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Measuring the implementation strength of a perinatal mental health intervention delivered by peer volunteers in rural Pakistan
Journal Pre-proof Measuring the implementation strength of a perinatal mental health intervention delivered by peer volunteers in rural Pakistan Ikhlaq Ahmad, Nadia Suleman, Ahmed Waqas, Najia Atif, Abid Ali Malik, Amina Bibi, Shaffaq Zulfiqar, Anum Nisar, Hashim Javed, Ahmed Zaidi, Zainab S. Khan, Siham Sikander PII:
S0005-7967(20)30010-3
DOI:
https://doi.org/10.1016/j.brat.2020.103559
Reference:
BRT 103559
To appear in:
Behaviour Research and Therapy
Received Date: 1 June 2018 Revised Date:
15 January 2020
Accepted Date: 20 January 2020
Please cite this article as: Ahmad, I., Suleman, N., Waqas, A., Atif, N., Malik, A.A., Bibi, A., Zulfiqar, S., Nisar, A., Javed, H., Zaidi, A., Khan, Z.S., Sikander, S., Measuring the implementation strength of a perinatal mental health intervention delivered by peer volunteers in rural Pakistan, Behaviour Research and Therapy (2020), doi: https://doi.org/10.1016/j.brat.2020.103559. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 Published by Elsevier Ltd.
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Measuring the implementation strength of a perinatal mental health intervention delivered
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by peer volunteers in rural Pakistan
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Ikhlaq Ahmad1,2, Nadia Suleman1, Ahmed Waqas1, Najia Atif1, Abid Ali Malik1, Amina Bibi1,
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Shaffaq Zulfiqar1, Anum Nisar1, Hashim Javed1, Ahmed Zaidi1, Zainab S Khan, Siham
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Sikander1, 2,
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Human Development Research Foundation, Pakistan;
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Health Services Academy, Islamabad, Pakistan;
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[email protected]
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[email protected],
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[email protected]
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[email protected], [email protected]
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[email protected], [email protected]
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[email protected], [email protected]
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[email protected]
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[email protected],
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Corresponding author:
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Ikhlaq Ahmad,
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Human Development Research Foundation, Islamabad
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Email: [email protected]
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Postal address: Hn. 06, Street 55, F-7/4 Islamabad, Pakistan
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Highlights • • • •
Implementation strength index is constructed based on four key constructs. Strength reflected provider competence and contact intensity. Index showed signification association clinical outcomes. Creating a single index may facilitate analyses.
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Abstract
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The South Asian region, including Pakistan, reports one of the highest rates of perinatal depression. Effective task-shifting perinatal mental health interventions exist and are gaining attention of policy makers, as a potential solution to bridge the existing treatment gap. However, no specific indicators are available to gauge the level of implementation for such interventions in the South Asian region.
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The Thinking Healthy Programme Peer-delivered (THPP) is a perinatal mental health intervention delivered, at scale, by peer volunteers (PVs). An effectiveness trial for THPP based on 570 depressed pregnant women was conducted in rural Rawalpindi, Pakistan. In addition, we also examined the implementation processes of THPP in order to develop an index to gauge implementation strength of this intervention.
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The key components of this index are based on four important intervention processes related to service provision which include; i) the competence of PVs, ii) supervisions attended by PVs and iii) number and duration of THPP sessions. We attempt to inform an implementation strength index which best correlates with reduced perinatal depression and disability at 6 months post childbirth. Knowledge of such an implementation strength index for a task-shifted perinatal depression intervention carries implications for scale up strategies.
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Keywords:
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Implementation strength, implementation strength index, THPP, measuring implementation intensity, perinatal depression, task-shifting, peer volunteers, Pakistan
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List of Abbreviations
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WHO
World Health Organization
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LMIC
low and middle income countries
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THP
Thinking Healthy Programme
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LHW
Lady Health Workers
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SHARE
South Asian hub for Advocacy Research and Education in mental health
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ISI
Implementation Strength Index
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THPP
Thinking Healthy Programme-Peer delivered
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WHO-DAS
World Health Organization Disability Assessment Schedule
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PHQ-9
Patient Health Questionnaire
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PV
Peer Volunteer
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ENACT
ENhancing Assessment of Common Therapeutic factors
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SPSS
Statistical Package for Social Sciences
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HDRF
Human Development Research Foundation
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Background
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The rates of perinatal depression are higher in low- and middle-income countries than high income countries (Parsons et al., 2011, Fisher et al., 2012). In LMICs, perinatal depression is largely under diagnosed and untreated due to the lack of skilled human resource, infrastructure and facilities; resulting in a huge treatment gap (Eaton et al., 2011). Effective interventions are available, but there are several barriers hindering their implementation on a wider scale (Nyatsanza, Schneider, Davies, & Lund, 2016), especially the shortage of skilled human resource (Saxena, Thornicroft, Knapp, & Whiteford, 2007). ‘Task shifting’ is an effective approach to alleviate shortage of health workforce.
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Task shifting has been used effectively to deliver maternal mental health programmes in the community (Petersen et al., 2011), by overcoming barriers hindering their scale up (Kakuma et al., 2011, Eaton et al., 2011, van Ginneken et al., 2013). It involves delegating tasks to either already existing workforce (such as community health workers, birth attendants) or creating a new cadre of workers trained to carry out a specialized task. One such example is the Thinking Healthy Programme (THP); a low intensity psychosocial intervention for perinatal depression delivered by the Lady Health Workers (LHW - government employees working on mother and child health agendas in the community).
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THP, endorsed by the WHO1, was tested for its effectiveness through a cluster randomised controlled trial in rural Pakistan. It demonstrated largest effect sizes in reducing perinatal depression than other perinatal psychological treatments tested in the LMIC (Rahman et al., 2013; Rahman, Malik, Sikander, Roberts, & Creed, 2008). Despite the strong evidence for its effectiveness, scale up of THP through LHWs was extremely challenging due to their excessive workload (Hafeez, Mohamud, Shiekh, Shah, & Jooma, 2011). The LHW delivered THP was later adapted for peer volunteers (PVs), as a potential solution to scaling-up of the THP.
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The PVs were local woman who shared either similar experiences (such as being a mother, or experienced similar psychosocial adversities) or similar characteristics (such as age, religion, ethnicity or socioeconomic status) as the target population and functioned voluntarily as a delivery agent of the THP (N. Atif et al., 2017; Singla et al., 2014). In order for the intervention to be deliverable by the PVs with no prior health experience, the content of THP was simplified after extensive formative research. (Atif et al., 2017; Singla et al., 2014). The effectiveness and cost effectiveness of this adapted version of the THP was evaluated through randomised trials in two diverse settings in Pakistan and India (Sikander et al., 2018).
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Implementation strength is defined as “measurement of strength or intensity of a program with which it has been delivered in real-world settings” (Carroll et al., 2007). This is different from 1
World Health Organization. Thinking Healthy: A Manual for Psychosocial Management of Perinatal Depression (WHO generic field-trial version 1.0). Geneva, WHO, 2015.
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intervention fidelity which refers to the degree to which an intervention is implemented as intended in the protocol. The implementation challenges of interventions delivered by nonspecialists have been highlighted especially in defining key components of intervention, measuring fidelity and training and supervision processes involved (Dixon, M., L., Melanie, & Crick, 2015).
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There are tools available to measure different aspects of implementation but a composite implementation strength measuring tool for mental health intervention is not readily available. Measuring implementation strength helps to determine the impact of different components of the program on intervention outcomes. It also helps inform scalability of the program in new settings and helps to differentiate between treatment failure and implementation failure. The present study reports the development of an Implementation Strength Index for a peer-delivered program for perinatal depression. To our knowledge, this is the first study that reports the development of an indicator of implementation strength for a psychosocial intervention conducted at a large scale in Pakistan. This study tests following the hypotheses:
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H1. A single index of implementation index has adequate factor validity and reliability.
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H2. A higher implementation index is associated with decreased severity of depressive symptoms and disability.
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Methods
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Setting:
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The present study was embedded in a cluster randomized controlled trial (based on 570 depressed women) that evaluated the effectiveness of THPP, conducted in sub-district Kallar Syedan of the District Rawalpindi. This sub-district is rural and predominantly agrarian with a population of approximately 200,000. It has eleven Union Councils (the smallest administrative unit), with each serving 10-15 adjacent villages (Sikander et al., 2015).
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Description of the Trial
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It was a community-based cluster randomized controlled trial (Sikander et al., 2018). Forty village clusters with a population of 2500 to 3600 were randomized equally into treatment and control conditions (20 clusters in each). A total of 570 depressed mothers were recruited, with 283 in the treatment arm receiving THPP sessions. After taking informed consent, trained clinical psychologists used Patient Health Questionnaire -9 items (PHQ-9) to screen and recruit pregnant women with depression. At baseline, those who scored >10 on PHQ-9 were enrolled into the study. The participants in the intervention arm received 10 individual and 4 group session by PVs in their community. At the end-line (6 months post childbirth), all mothers were assessed for depression (PHQ-9) and for disability (using WHO-DAS). Both instruments are cross culturally validated and have been used in earlier studies in Pakistan (Castro et al., 2015; Gallis et al., 2018; Hamdani et al., 2017; Kroenke, Spitzer, & Williams, 2001). 6
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Description of Thinking Healthy Program Peer-delivered
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Forty-five local women (peer volunteers) were identified, recruited, trained and supervised to deliver the Thinking Healthy Programme- Peer Delivered (THPP). They worked in close collaboration with the local LHWs to deliver THPP to depressed mothers (n=283). Local health facilities were used as training and supervision centres for PVs, supervisors of LHWs also participated in trainings and supervisions. THPP entails ten home-based individual sessions and four group sessions delivered between the periods of third trimester of pregnancy till six months postnatal (Najia Atif et al., 2016).
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The PVs were trained using the cascade model of training and supervision. The master trainer (mental health specialist), trained and supervised the THPP facilitators (university graduates with no mental health experience), who in turn trained and supervised the PVs. Four intervention facilitators were recruited as full time employees. The facilitators’ training involved classroom training (20 hours), which was followed by six months of field training. The classroom training focused on building capacity of intervention facilitators in use of counselling skills, CBT approach, in-depth understanding of strategies used in delivery of THPP. They were also trained in identification and management of potential risks. The field training was aimed to help the facilitators gain first-hand experience of delivering the intervention. During field training, they received regular fortnightly supervisions via Skype.
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The Facilitators, on the completion of their training, trained and supervised the PVs at their local primary care facilities called Basic Health Units (BHU). PVs’ classroom trainings focused on psycho-education, use of basic counselling skills, in-depth understanding of the THPP, and its delivery. The PVs received monthly group supervisions for their continuous support and learning. Details of the cascade model of training and supervision can be found elsewhere (N. Atif et al., 2018). Figure 1 shows the cascade model of training and supervision.
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Development of Implementation Index
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Different approaches are available to measure the implementation of a public health programme. Hargreaves and colleagues suggest five step approach for measuring implementation strength of a given program: i) developing a logic model, ii) identifying key indicators of implementation, iii) collection and analyses of data from various sources, iv) developing a composite measure for implementation strength, and v) correlating implementation index and clinical outcomes (Hargreaves et al 2016). We applied this five-step approach to the context of THPP (Table 1). The logic model shows the pathways for improving maternal mental health outcomes. We identified several inputs, processes and outputs required to achieve a good clinical impact as shown in the logic model. We also delineated two key maternal mental health outcomes including depressive symptoms and disability.
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Identifying key indicators for implementation strength and analysing the data
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For the construction of implementation index, we used only services provider level indicators. Based on the logic model and consultations with the intervention development and implementation team, we identified four key indicators to construct this measurement tool in context of the THPP. These indicators included: dose delivered i.e. number of THPP sessions; duration of the session; competency of peers and their attendance in monthly supervision sessions. Initially, it was proposed that the amount of training and supervision received by the peers should also be used as an indicator for implementation index. However, we dropped it since the amount of training and supervision received was consistent across all the peers (since they all received the same number of training hours).
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Process data on these indicators were collected for 45 PVs. Each indicator was weighted on a 0100 percentage scale to facilitate scoring (J. Schellenberg, Bobrova, N., Avan, BI, 2012). Data on dosage and duration of the THPP session was marked on specifically designed session logs maintained by the intervention facilitators and peers. Dosage was defined as the “total number of the sessions delivered by peers, divided by the maximum number of sessions (14 for each participant), multiplied by 100”. For instance, if a PV were allotted three participants, she was supposed to have delivered a maximum of 42 sessions to these three participants. In case, a peer delivered 35 sessions in all, the dosage delivered would be calculated as 35 divided by 42 and multiplied by 100 meaning 83% dosage delivered by this peer.
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Similarly, session duration was defined as “duration of the session divided by the ideal duration of a THPP session, multiplied by 100”. The team decided that the ideal duration of a session would be around 45 minutes to deliver the content appropriately. Duration of each session was recorded in the PV intervention session logs by the respective peers, themselves. For example, if a peer delivered 35 sessions to her three depressed trial participants, with 1200 minutes recorded on the logs divided by total ideal duration for these sessions i.e. 1575 minutes multiplied by 100, gives us 76% score on the duration indicator.
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Similarly, competency of each peer was evaluated by intervention facilitators using competency checklist. The checklist was informed by ENhancing Assessment of Common Therapeutic factors (ENACT); an 18-items tool, used by the non-specialists for peer ratings of skills for delivering psychosocial interventions in low-resource settings (Kohrt et al., 2015). Competency of each peer was evaluated at 3 time-points during the implementation of THPP (immediately after training, at one year and then at 18 months’ post training) (N. Atif et al., 2018). We used the average of these three-time point as the accumulative competency of each peer, presented as percentage scores.
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Attendance of the PVs during supervisions was recorded by intervention facilitators during the implementation of the programme. These attendance records were then converted into 8
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percentages for each peer calculated as total number of supervision sessions attended by each peer divided by maximum number of supervision sessions available for each peer (during the implementation phase) and multiplied by 100. Implementation strength indices were calculated at the peer level rather than at the cluster level because there was more than one peer in one village cluster. Each peer was assigned three to seven mothers with depression, to deliver sessions of THPP.
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Outcomes
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Data on outcomes that is depression and disability were collected at 6-month post childbirth. The nine-item Patient Health Questionnaire (PHQ-9) was used as a measure of depression and WHODAS for disability.
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Statistical Analysis
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All analyses were done using SPSS (v.21). To explore the association between implementation index scores and clinical outcomes, PHQ-9 and disability scores (i.e. depression and disability) regression analysis was done. Scatter plots were also used for visual representation of the associations between implementation index and clinical outcomes. Implementation strength index was plotted on x-axis whereas PHQ-9 and disability scores were plotted on y-axis. Fitted line was drawn to examine the possible relationship between implementation index and outcomes. Baseline scores on PHQ-9 and WHODAS were not used as controlling variables in the regression models. To yield a composite score on the implementation index, firstly, percentage scores were computed independently for each of the four indicators identified. Secondly, these independently drawn percentage scores were grouped for an accumulative score i.e., implementation strength index, ranging from 0-100 percent (Gold, Singh, & Frost, 1993). The higher the score, the better the implementation strength.
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Principal Component Analysis (PCA) was used to determine factor validity of the implementation index. Before running the PCA, adequacy of sample size was determined using the KMO measure of sampling adequacy and Bartlett’s test of sphericity. Number of factors to retain was decided on two main criteria: Eigen value > 1 and Cattell Scree plot. Only those items were retained that had a KMO value > 0.5 in the anti-image of the correlation matrix, a communality > 0.2 and factor loading > 0.32. Internal consistency of the implementation index was measured using the Cronbach’s alpha considered acceptable at 0.60. PCA and reliability analysis were conducted using the FACTOR programme.
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Results
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Characteristics of Peer Volunteers (PVs)
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Basic demographic characteristics of peers are given in Table 2. Average competency of peers was 82.67% (SD=6.45), number of sessions delivered were 92.15% (SD=6.51), duration of
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sessions 81.23% (SD=9.72) and number of supervised sessions attended were 64.62% (SD=24.15).
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Association between implementation strength index and clinical outcomes
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The implementation strength index for THPP ranged from 77% to 96% at the level of individual peers, corresponding to a good level of implementation. There was no significant association between PHQ-9 scores and implementation strength index (p= 0.805), as indicated in Table 3. A one-unit increase in implementation strength resulted in a decrease of 0.03 units in PHQ-9 scores. Although the correlation was statistically non-significant, a weak inverse relationship was evident between implementation strength index and the severity of depressive symptoms. However, implementation index was significantly correlated with the disability measure (p=0.002).
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Table 3 demonstrates a strong relationship between measure of disability and implementation index of THPP (p= 0.002). A unit increase in implementation strength led to 0.44 points decrease in disability scores. Peer level scatter plots with fitted regression lines between changes in implementation index of THPP and depression and disability scores are shown in figure 2 and 3.
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Dimension reduction & internal consistency
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Principal component analysis (PCA) was performed to affirm the factor validity of the implementation index. The study sample was found to have a slightly lower Kaiser-Meyer-Olkin measure of sampling adequacy (0.57) and a statistically significant Bartlett’s test of sphericity (X2=8.0, P=0.04). Based on the criteria of Eigen value > 1, Cattell scree plot and parallel analysis, only one factor was retained. This factor explained 49.43% of the cumulative proportion of the variance in implementation strength index. All items except the duration of session was found to have a communality value > 0.20 and factor loadings > 0.32 (Table 4). The duration of sessions yielded a communality value of 0.002 and factor loading of 0.04, hence, it was excluded from the final analysis. Alpha coefficient value for the implementation strength index comprising the three items was 0.49 which was lower than the accepted value of 0.60.
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Discussion
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Summary of results
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This article reports the development of first index to gauge the implementation strength of a peer mediated perinatal mental health intervention in a low- and middle-income country. Exploratory factor analysis and reliability indices depicted a valid and reliable implementation strength index comprising of three service delivery level indices: competency levels, average number of sessions and number of supervised sessions. Inverse relationship between implementation 10
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strength index and total scores on WHODAS was observed, however, it yielded no significant association with scores on PHQ-9.
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Development of implementation index
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The development of the implementation index was done in accordance with our logic model and an extensive consultation process with the intervention developers and delivery team. These four service provider level indicators were identified as crucial components of an implementation index. These are mainly competency of delivery agents, dosage of interventions, number of sessions delivered and duration of each session. One of the key barriers in the choice of indicators for implementation strength was the lack of literature relevant to psychological interventions. Therefore, implementation indices developed for public health programs in other domains were consulted. A few of these programs were summarized and critically evaluated in two key literature reviews (Schellenberg et al., 2012; Hargreaves et al., 2016). Methodological
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Statistical validation
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The development procedure of the implementation index ensured inclusion of service delivery agents and intervention experts, ensuring a good face validity. After the testing of this implementation index in the field, its dimensionality and content validity were tested using several statistical validation procedures. Exploratory factor analysis was done to ascertain the dimensionality of the implementation index. It revealed a unidimensional factor structure explaining 49% of the variance in the index scores. However, it deemed only three out of four of the indicators to be suitable for calculating the overall implementation index; leading to exclusion of “duration of sessions” component from the implementation index. Reliability analysis revealed an unacceptable internal consistency of the IS index. This may be due to several reasons. Firstly, Cronbach’s alpha value is dependent on the number of items in a scale which disadvantages the use of an index based on only three items (University of Virginia Library, 2015). In addition, competency and supervision are strongly related to quality of the intervention than number of supervised sessions or duration of session. Hence, the items or constructs included in the implementation index were quite heterogeneous, thus, further lowering the alpha value. This has been shown in several psychometric studies where heterogeneity in
gaps, limitations and a lack of consensus on defining and measuring implementation were identified in these two reviews. These two reviews also developed a framework for future indices of
implementation strength and provided several case studies highlighting their use of public health programs. Most of the programmes fulfil the needs of a project and cannot be generalised in other settings. Moreover, only a few of the programs provided validation procedures for their tools or associations between implementation processes and outcomes.
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items led to poor Cronbach’s alpha values (Ruuttu et al., 2006; Andrews et al., 1993; Andrews et al.,1989).
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Association of implementation strength index with depressive symptoms and disability
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Albeit the implementation index was a significant predictor of WHODAS scores, it did not yield a significant association with PHQ-9 scores. However, the peer volunteers exhibited good scores on implementation indices, showing little variability in the implementation strength. There could be a myriad of reasons for this statistical insignificance. Firstly, the implementation indices chosen may be suitable for exploring disability but not depressive symptoms among pregnant women. Secondly, the association between the THPP intervention and PHQ-9 may be driven by other constructs of implementation. We encourage future research for identifying more constructs of implementation that are strongly associated with the outcomes. Thirdly, the use of simplistic scoring matrix for calculation of implementation strength is yet another limitation that may have yielded non-significant results.
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It is suggested that future studies should use more transparent weighting and scoring systems (J. Schellenberg, Bobrova, N., Avan, BI, 2012). Hargreaves et al suggested this by creating a more representative composite scoring system, based on factor analysis loadings of individual components or by conducting a regression analyses to determine their relative weights (Hargreaves et al 2016). Lastly, this non-significant association between PHQ-9 scores and implementation index may also reflect the ineffectiveness of the THPP intervention in maintaining remission of depressive symptoms at six-month follow-up in the parent trial (Sikander et al., 2019). The THPP program is based on an evidence-based CBT model, however, significant challenges exist in its delivery by peer volunteers in Pakistan. It should, however, be noted that successful trials have previously been conducted where lady health workers were employed as delivery agents of THP intervention.
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Rationale for mixed findings
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The answer for the mixed findings for depression severity and disability may be due to the complex nature of the relationship between these two constructs (Bruce, 2000). This has been documented in previous research showing heterogeneous trajectories of depressive symptoms and poor psychosocial functioning (Bruce, 2001; Yaroslavsky et al. 2013; Peer and Spaulding 2007). Measures of disability such as the WHODAS assess psychosocial disability as perceived by the study participants. Further research is encouraged to explore the rationale for the usefulness of THPP in reducing disability but not depressive symptoms. Unpacking of the THPP intervention into its specific and non-specific therapeutic components may be the key to finding this answer (Fixsen, Naoom, Blase, & Friedman, 2005).
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Direction for future research
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It would be ideal to use individual participant level data instead of calculating means for participants assigned to one peer in future studies. Further insights into key components of the 12
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intervention to develop implementation indices that are more sensitive to outcome measures is highly recommended. A limitation in this study, was the use of session logs maintained by peers themselves for recording dose and duration of the THPP session. This may have introduced a reporting bias in reporting of these two indicators. However, literature does support the use of such self-reported and self-documented measures despite its limitations (Grizzard, Bartick, Nikolov, Griffin, & Lee, 2006). Future research studies should focus on identifying more components of implementation strength along with robust method for measuring them. This might be helpful to identify which constructs are strongly correlated with the outcomes.
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Conclusion
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Development of implementation index for evidence-based task-shifted psychological interventions is necessary to aid in scale up of these programmes. Policy makers and local governments can use these findings to monitor their implementation strength and impact on clinical outcomes. Developing a measure for assessing implementation strength of THPP will also be a useful addition to monitor packages of intervention being implemented in the LMICs.
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Ethical considerations
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The development of implementation index for THPP was based on existing data collected as part of the randomised trial. The trial had ethical clearance from, the Institutional Review Board of Human Development Research Foundation (HDRF) Pakistan, and the University of Liverpool, UK.
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Conflict of Interest
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No competing interests reported by authors.
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Acknowledgement
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We acknowledge the contribution of all peer volunteers for their assistance and support in the field.
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Funding
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This research did not receive any grant/funds from any agency in the public, commercial or notfor-profit sectors.
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Keller, M. B., McCullough, J. P., Klein, D. N., Arnow, B., Dunner, D. L., Gelenberg, A. J., . . . Zajecka, J. (2000). A Comparison of Nefazodone, the Cognitive Behavioral-Analysis System of Psychotherapy, and Their Combination for the Treatment of Chronic Depression. New England Journal of Medicine, 342(20), 1462-1470. doi: 10.1056/nejm200005183422001 Kessler, R. C. (1997). THE EFFECTS OF STRESSFUL LIFE EVENTS ON DEPRESSION. Annual Review of Psychology, 48(1), 191-214. doi: 10.1146/annurev.psych.48.1.191 Kohrt, B. A., Jordans, M. J., Rai, S., Shrestha, P., Luitel, N. P., Ramaiya, M. K., . . . Patel, V. (2015). Therapist competence in global mental health: Development of the ENhancing Assessment of Common Therapeutic factors (ENACT) rating scale. Behav Res Ther, 69, 11-21. doi: 10.1016/j.brat.2015.03.009 Kroenke, K., Spitzer, R. L., & Williams, J. B. (2001). The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med, 16. doi: 10.1046/j.1525-1497.2001.016009606.x Nyatsanza, M., Schneider, M., Davies, T., & Lund, C. (2016). Filling the treatment gap: developing a task sharing counselling intervention for perinatal depression in
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Khayelitsha, South Africa. BMC Psychiatry, 16, 164. doi: 10.1097/nmd.0000000000000530
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10.1186/s12888-016-0873-y Petersen, I., Lund, C., Bhana, A., Flisher, A. J., Health, M., & Consortium, P. R. P. (2011). A task shifting approach to primary mental health care for adults in South Africa: human resource requirements and costs for rural settings. Health Policy and Planning, 27(1), 4251. Peer JE, Spaulding WD. Heterogeneity in recovery of psychosocial functioning during psychiatric rehabilitation: an exploratory study using latent growth mixture modeling. Schizophrenia research. 2007 Jul 1;93(1-3):186-93. Rahman, A., Fisher, J., Bower, P., Luchters, S., Tran, T., Yasamy, M. T., . . . Waheed, W. (2013). Interventions for common perinatal mental disorders in women in low-and middle-income countries: a systematic review and meta-analysis. Bulletin of the World Health Organization, 91. doi: 10.2471/blt.12.109819 Rahman, A., Malik, A., Sikander, S., Roberts, C., & Creed, F. (2008). Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial. Lancet, 372. doi: 10.1016/s0140-6736(08)61400-2 Saxena, S., Thornicroft, G., Knapp, M., & Whiteford, H. (2007). Resources for mental health: scarcity, inequity, and inefficiency. Lancet, 370(9590), 878-889. doi: 10.1016/s01406736(07)61239-2 Schellenberg, J., Bobrova, N., & Avan, B. (2012). Measuring implementation strength: literature review draft report 2012. Measuring implementation strength: Literature review draft report 2012. Measuring implementation strength: Literature review draft report 2012. In K. Sabot (Ed.): London School of Hygiene & Tropical Medicine. Sikander, S., Ahmad, I., Atif, N., Zaidi, A., Vanobberghen, F., & Helen A. Weiss3, A. N., Hanani Tabana4, Qurat Ul Ain1, Amina Bibi1, Samina Bilal1, Tayyiba Bibi1, Rakshanda Liaqat1 , Maria Sharif1, Shaffaq Zulfiqar1, Daniela C Fuhr5, LeShawndra N Price6*, Vikram Patel7V and Atif Rahman8V (2018). Delivering the Thinking Healthy Programme for perinatal depression through volunteer
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peers: a cluster randomised controlled trial in Pakistan. Lancet Psychiatry, (Under review). Sikander, S., Lazarus, A., Bangash, O., Fuhr, D. C., Weobong, B., Krishna, R. N., . . . Patel, V. (2015). The effectiveness and cost-effectiveness of the peer-delivered Thinking Healthy Programme for perinatal depression in Pakistan and India: the SHARE study protocol for randomised controlled trials. Trials, 16(1), 534. doi: 10.1186/s13063-015-1063-9 Sikander S, Ahmad I, Atif N, Zaidi A, Vanobberghen F, Weiss HA, Nisar A, Tabana H, Ain QU, Bibi A, Bilal S. Delivering the Thinking Healthy Programme for perinatal depression through volunteer peers: a cluster randomised controlled trial in Pakistan. The Lancet Psychiatry. 2019 Feb 1;6(2):128-39. Singla, D., Lazarus, A., Atif, N., Sikander, S., Bhatia, U., Ahmad, I., . . . Rahman, A. (2014). “Someone like us”: Delivering maternal mental health through peers in two South Asian contexts. Journal of Affective Disorders, 168, 452-458. doi: 10.1016/j.jad.2014.07.017 SPSS. The SPSS TwoStep Cluster Component: A scalable component enabling more efficient customer segmentation [Internet]. 2001. Available: http://www.spss.ch/upload/1122644952_The SPSS TwoStep Cluster Component.pdf 16
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van Ginneken, N., Tharyan, P., Lewin, S., Rao, G. N., Meera, S. M., Pian, J., . . . Patel, V. (2013). Non-specialist health worker interventions for the care of mental, neurological and substance-abuse disorders in low- and middle-income countries. Cochrane Database Syst Rev(11), Cd009149. doi: 10.1002/14651858.CD009149.pub2
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Yaroslavsky I, Pettit JW, Lewinsohn PM, Seeley JR, Roberts RE. Heterogeneous trajectories of depressive symptoms: Adolescent predictors and adult outcomes. Journal of affective disorders. 2013 Jun 1;148(2-3):391-9.
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1 2
Table 1: Logic model Inputs Master trainer
Intervention facilitators
Intervention Package (THPP)
Processes Collaboration with primary health care system
Outputs Competency of the Peer Volunteers
Identification of Peer Volunteers
Intervention delivered to mothers
Training and supervision of Peer Volunteers
Attendance of the PVs in supervisions
Funds
Outcomes Reduction in depressive symptoms (PHQ-9 scores at 6th month post childbirth)
Impact Improved maternal mental health
Reduction in disability (WHO-DAS scores at 6th month post childbirth)
3 4 5
Variables
(%)
Age (mean, [SD]) 18-25 26-35 36 - 45
30 [5.7] 7 (15.6%) 29 (64.4%) 9 (20%)
2:
6
Demographic
7
characteristics
8 9 10
18
Table
of
Peer Volunteers
(n=45)
Highest level of education completed (mean, 12 [2.1] 22 (49%) [SD]) Secondary 9 (20%) Intermediate 14 (31%) Graduate Married 33 (73.3%) Single 10 (22.2%) Divorced 2 (4.5%) No of children (mean, SD) 2 [2.0]
1 2 3 4
5 6 7 8 9 10 11
Table 3: Association between PHQ-9 and Implementation Strength Index (n=45) Implementation strength index Predictor
SE B
β
F
R2
p
.105
-.038
.061
.001
.805
Model 1
PHQ-9
Model 2
19
WHO-DAS
.31
-.44
10.34
.19
.002
1
Note: PHQ-9=Patient Health Questionnaire; WHO-DAS=World Health Organization Disability
2
Assessment Schedule
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Table 4: Factor analysis for Implementation Strength Index Variable
Factor loading
Communality
Competency
0.82
0.67
Average number of sessions
0.57
0.32
Number of supervised
0.70
0.49
sessions 10 11 12
20
Figure 1: Cascade model of training and supervision
Master Trainer in UK
Local Trainers in Pakistan
Volunteer Peers in rural Rawalpindi
Women with perinatal depression in villages
Figure 1: Association between PHQ-9 and ISI
Association between PHQ-9 and ISI (n=45) 14
PHQ-9 scores
12 10 8 6 4 2 0 75
80
85
90
ISI
95
100
Figure 3: Association between WHO-DAS and ISI
Assocation between WHO-DAS and ISI (n=45) 40
WHODAS scores
35 30 25 20 15 10 5 0 75
80
85
90
ISI
95
Highlights • • • •
Implementation strength index is constructed based on four key constructs. Strength reflected provider competence and contact intensity. Index showed signification association clinical outcomes. Creating a single index may facilitate analyses.
S0005-7967(20)30010-3
DOI:
https://doi.org/10.1016/j.brat.2020.103559
Reference:
BRT 103559
To appear in:
Behaviour Research and Therapy
Received Date: 1 June 2018 Revised Date:
15 January 2020
Accepted Date: 20 January 2020
Please cite this article as: Ahmad, I., Suleman, N., Waqas, A., Atif, N., Malik, A.A., Bibi, A., Zulfiqar, S., Nisar, A., Javed, H., Zaidi, A., Khan, Z.S., Sikander, S., Measuring the implementation strength of a perinatal mental health intervention delivered by peer volunteers in rural Pakistan, Behaviour Research and Therapy (2020), doi: https://doi.org/10.1016/j.brat.2020.103559. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 Published by Elsevier Ltd.
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Measuring the implementation strength of a perinatal mental health intervention delivered
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by peer volunteers in rural Pakistan
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Ikhlaq Ahmad1,2, Nadia Suleman1, Ahmed Waqas1, Najia Atif1, Abid Ali Malik1, Amina Bibi1,
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Shaffaq Zulfiqar1, Anum Nisar1, Hashim Javed1, Ahmed Zaidi1, Zainab S Khan, Siham
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Sikander1, 2,
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1
Human Development Research Foundation, Pakistan;
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2
Health Services Academy, Islamabad, Pakistan;
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[email protected]
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[email protected],
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[email protected]
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[email protected], [email protected]
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[email protected], [email protected]
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[email protected], [email protected]
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[email protected]
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[email protected],
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Corresponding author:
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Ikhlaq Ahmad,
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Human Development Research Foundation, Islamabad
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Email: [email protected]
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Postal address: Hn. 06, Street 55, F-7/4 Islamabad, Pakistan
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1
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Highlights • • • •
Implementation strength index is constructed based on four key constructs. Strength reflected provider competence and contact intensity. Index showed signification association clinical outcomes. Creating a single index may facilitate analyses.
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1
Abstract
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The South Asian region, including Pakistan, reports one of the highest rates of perinatal depression. Effective task-shifting perinatal mental health interventions exist and are gaining attention of policy makers, as a potential solution to bridge the existing treatment gap. However, no specific indicators are available to gauge the level of implementation for such interventions in the South Asian region.
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The Thinking Healthy Programme Peer-delivered (THPP) is a perinatal mental health intervention delivered, at scale, by peer volunteers (PVs). An effectiveness trial for THPP based on 570 depressed pregnant women was conducted in rural Rawalpindi, Pakistan. In addition, we also examined the implementation processes of THPP in order to develop an index to gauge implementation strength of this intervention.
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The key components of this index are based on four important intervention processes related to service provision which include; i) the competence of PVs, ii) supervisions attended by PVs and iii) number and duration of THPP sessions. We attempt to inform an implementation strength index which best correlates with reduced perinatal depression and disability at 6 months post childbirth. Knowledge of such an implementation strength index for a task-shifted perinatal depression intervention carries implications for scale up strategies.
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Keywords:
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Implementation strength, implementation strength index, THPP, measuring implementation intensity, perinatal depression, task-shifting, peer volunteers, Pakistan
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1
List of Abbreviations
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WHO
World Health Organization
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LMIC
low and middle income countries
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THP
Thinking Healthy Programme
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LHW
Lady Health Workers
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SHARE
South Asian hub for Advocacy Research and Education in mental health
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ISI
Implementation Strength Index
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THPP
Thinking Healthy Programme-Peer delivered
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WHO-DAS
World Health Organization Disability Assessment Schedule
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PHQ-9
Patient Health Questionnaire
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PV
Peer Volunteer
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ENACT
ENhancing Assessment of Common Therapeutic factors
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SPSS
Statistical Package for Social Sciences
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HDRF
Human Development Research Foundation
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Background
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The rates of perinatal depression are higher in low- and middle-income countries than high income countries (Parsons et al., 2011, Fisher et al., 2012). In LMICs, perinatal depression is largely under diagnosed and untreated due to the lack of skilled human resource, infrastructure and facilities; resulting in a huge treatment gap (Eaton et al., 2011). Effective interventions are available, but there are several barriers hindering their implementation on a wider scale (Nyatsanza, Schneider, Davies, & Lund, 2016), especially the shortage of skilled human resource (Saxena, Thornicroft, Knapp, & Whiteford, 2007). ‘Task shifting’ is an effective approach to alleviate shortage of health workforce.
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Task shifting has been used effectively to deliver maternal mental health programmes in the community (Petersen et al., 2011), by overcoming barriers hindering their scale up (Kakuma et al., 2011, Eaton et al., 2011, van Ginneken et al., 2013). It involves delegating tasks to either already existing workforce (such as community health workers, birth attendants) or creating a new cadre of workers trained to carry out a specialized task. One such example is the Thinking Healthy Programme (THP); a low intensity psychosocial intervention for perinatal depression delivered by the Lady Health Workers (LHW - government employees working on mother and child health agendas in the community).
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THP, endorsed by the WHO1, was tested for its effectiveness through a cluster randomised controlled trial in rural Pakistan. It demonstrated largest effect sizes in reducing perinatal depression than other perinatal psychological treatments tested in the LMIC (Rahman et al., 2013; Rahman, Malik, Sikander, Roberts, & Creed, 2008). Despite the strong evidence for its effectiveness, scale up of THP through LHWs was extremely challenging due to their excessive workload (Hafeez, Mohamud, Shiekh, Shah, & Jooma, 2011). The LHW delivered THP was later adapted for peer volunteers (PVs), as a potential solution to scaling-up of the THP.
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The PVs were local woman who shared either similar experiences (such as being a mother, or experienced similar psychosocial adversities) or similar characteristics (such as age, religion, ethnicity or socioeconomic status) as the target population and functioned voluntarily as a delivery agent of the THP (N. Atif et al., 2017; Singla et al., 2014). In order for the intervention to be deliverable by the PVs with no prior health experience, the content of THP was simplified after extensive formative research. (Atif et al., 2017; Singla et al., 2014). The effectiveness and cost effectiveness of this adapted version of the THP was evaluated through randomised trials in two diverse settings in Pakistan and India (Sikander et al., 2018).
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Implementation strength is defined as “measurement of strength or intensity of a program with which it has been delivered in real-world settings” (Carroll et al., 2007). This is different from 1
World Health Organization. Thinking Healthy: A Manual for Psychosocial Management of Perinatal Depression (WHO generic field-trial version 1.0). Geneva, WHO, 2015.
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intervention fidelity which refers to the degree to which an intervention is implemented as intended in the protocol. The implementation challenges of interventions delivered by nonspecialists have been highlighted especially in defining key components of intervention, measuring fidelity and training and supervision processes involved (Dixon, M., L., Melanie, & Crick, 2015).
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There are tools available to measure different aspects of implementation but a composite implementation strength measuring tool for mental health intervention is not readily available. Measuring implementation strength helps to determine the impact of different components of the program on intervention outcomes. It also helps inform scalability of the program in new settings and helps to differentiate between treatment failure and implementation failure. The present study reports the development of an Implementation Strength Index for a peer-delivered program for perinatal depression. To our knowledge, this is the first study that reports the development of an indicator of implementation strength for a psychosocial intervention conducted at a large scale in Pakistan. This study tests following the hypotheses:
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H1. A single index of implementation index has adequate factor validity and reliability.
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H2. A higher implementation index is associated with decreased severity of depressive symptoms and disability.
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Methods
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Setting:
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The present study was embedded in a cluster randomized controlled trial (based on 570 depressed women) that evaluated the effectiveness of THPP, conducted in sub-district Kallar Syedan of the District Rawalpindi. This sub-district is rural and predominantly agrarian with a population of approximately 200,000. It has eleven Union Councils (the smallest administrative unit), with each serving 10-15 adjacent villages (Sikander et al., 2015).
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Description of the Trial
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It was a community-based cluster randomized controlled trial (Sikander et al., 2018). Forty village clusters with a population of 2500 to 3600 were randomized equally into treatment and control conditions (20 clusters in each). A total of 570 depressed mothers were recruited, with 283 in the treatment arm receiving THPP sessions. After taking informed consent, trained clinical psychologists used Patient Health Questionnaire -9 items (PHQ-9) to screen and recruit pregnant women with depression. At baseline, those who scored >10 on PHQ-9 were enrolled into the study. The participants in the intervention arm received 10 individual and 4 group session by PVs in their community. At the end-line (6 months post childbirth), all mothers were assessed for depression (PHQ-9) and for disability (using WHO-DAS). Both instruments are cross culturally validated and have been used in earlier studies in Pakistan (Castro et al., 2015; Gallis et al., 2018; Hamdani et al., 2017; Kroenke, Spitzer, & Williams, 2001). 6
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Description of Thinking Healthy Program Peer-delivered
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Forty-five local women (peer volunteers) were identified, recruited, trained and supervised to deliver the Thinking Healthy Programme- Peer Delivered (THPP). They worked in close collaboration with the local LHWs to deliver THPP to depressed mothers (n=283). Local health facilities were used as training and supervision centres for PVs, supervisors of LHWs also participated in trainings and supervisions. THPP entails ten home-based individual sessions and four group sessions delivered between the periods of third trimester of pregnancy till six months postnatal (Najia Atif et al., 2016).
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The PVs were trained using the cascade model of training and supervision. The master trainer (mental health specialist), trained and supervised the THPP facilitators (university graduates with no mental health experience), who in turn trained and supervised the PVs. Four intervention facilitators were recruited as full time employees. The facilitators’ training involved classroom training (20 hours), which was followed by six months of field training. The classroom training focused on building capacity of intervention facilitators in use of counselling skills, CBT approach, in-depth understanding of strategies used in delivery of THPP. They were also trained in identification and management of potential risks. The field training was aimed to help the facilitators gain first-hand experience of delivering the intervention. During field training, they received regular fortnightly supervisions via Skype.
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The Facilitators, on the completion of their training, trained and supervised the PVs at their local primary care facilities called Basic Health Units (BHU). PVs’ classroom trainings focused on psycho-education, use of basic counselling skills, in-depth understanding of the THPP, and its delivery. The PVs received monthly group supervisions for their continuous support and learning. Details of the cascade model of training and supervision can be found elsewhere (N. Atif et al., 2018). Figure 1 shows the cascade model of training and supervision.
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Development of Implementation Index
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Different approaches are available to measure the implementation of a public health programme. Hargreaves and colleagues suggest five step approach for measuring implementation strength of a given program: i) developing a logic model, ii) identifying key indicators of implementation, iii) collection and analyses of data from various sources, iv) developing a composite measure for implementation strength, and v) correlating implementation index and clinical outcomes (Hargreaves et al 2016). We applied this five-step approach to the context of THPP (Table 1). The logic model shows the pathways for improving maternal mental health outcomes. We identified several inputs, processes and outputs required to achieve a good clinical impact as shown in the logic model. We also delineated two key maternal mental health outcomes including depressive symptoms and disability.
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Identifying key indicators for implementation strength and analysing the data
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For the construction of implementation index, we used only services provider level indicators. Based on the logic model and consultations with the intervention development and implementation team, we identified four key indicators to construct this measurement tool in context of the THPP. These indicators included: dose delivered i.e. number of THPP sessions; duration of the session; competency of peers and their attendance in monthly supervision sessions. Initially, it was proposed that the amount of training and supervision received by the peers should also be used as an indicator for implementation index. However, we dropped it since the amount of training and supervision received was consistent across all the peers (since they all received the same number of training hours).
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Process data on these indicators were collected for 45 PVs. Each indicator was weighted on a 0100 percentage scale to facilitate scoring (J. Schellenberg, Bobrova, N., Avan, BI, 2012). Data on dosage and duration of the THPP session was marked on specifically designed session logs maintained by the intervention facilitators and peers. Dosage was defined as the “total number of the sessions delivered by peers, divided by the maximum number of sessions (14 for each participant), multiplied by 100”. For instance, if a PV were allotted three participants, she was supposed to have delivered a maximum of 42 sessions to these three participants. In case, a peer delivered 35 sessions in all, the dosage delivered would be calculated as 35 divided by 42 and multiplied by 100 meaning 83% dosage delivered by this peer.
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Similarly, session duration was defined as “duration of the session divided by the ideal duration of a THPP session, multiplied by 100”. The team decided that the ideal duration of a session would be around 45 minutes to deliver the content appropriately. Duration of each session was recorded in the PV intervention session logs by the respective peers, themselves. For example, if a peer delivered 35 sessions to her three depressed trial participants, with 1200 minutes recorded on the logs divided by total ideal duration for these sessions i.e. 1575 minutes multiplied by 100, gives us 76% score on the duration indicator.
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Similarly, competency of each peer was evaluated by intervention facilitators using competency checklist. The checklist was informed by ENhancing Assessment of Common Therapeutic factors (ENACT); an 18-items tool, used by the non-specialists for peer ratings of skills for delivering psychosocial interventions in low-resource settings (Kohrt et al., 2015). Competency of each peer was evaluated at 3 time-points during the implementation of THPP (immediately after training, at one year and then at 18 months’ post training) (N. Atif et al., 2018). We used the average of these three-time point as the accumulative competency of each peer, presented as percentage scores.
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Attendance of the PVs during supervisions was recorded by intervention facilitators during the implementation of the programme. These attendance records were then converted into 8
1 2 3 4 5 6
percentages for each peer calculated as total number of supervision sessions attended by each peer divided by maximum number of supervision sessions available for each peer (during the implementation phase) and multiplied by 100. Implementation strength indices were calculated at the peer level rather than at the cluster level because there was more than one peer in one village cluster. Each peer was assigned three to seven mothers with depression, to deliver sessions of THPP.
7
Outcomes
8 9 10
Data on outcomes that is depression and disability were collected at 6-month post childbirth. The nine-item Patient Health Questionnaire (PHQ-9) was used as a measure of depression and WHODAS for disability.
11
Statistical Analysis
12 13 14 15 16 17 18 19 20 21 22 23
All analyses were done using SPSS (v.21). To explore the association between implementation index scores and clinical outcomes, PHQ-9 and disability scores (i.e. depression and disability) regression analysis was done. Scatter plots were also used for visual representation of the associations between implementation index and clinical outcomes. Implementation strength index was plotted on x-axis whereas PHQ-9 and disability scores were plotted on y-axis. Fitted line was drawn to examine the possible relationship between implementation index and outcomes. Baseline scores on PHQ-9 and WHODAS were not used as controlling variables in the regression models. To yield a composite score on the implementation index, firstly, percentage scores were computed independently for each of the four indicators identified. Secondly, these independently drawn percentage scores were grouped for an accumulative score i.e., implementation strength index, ranging from 0-100 percent (Gold, Singh, & Frost, 1993). The higher the score, the better the implementation strength.
24 25 26 27 28 29 30 31
Principal Component Analysis (PCA) was used to determine factor validity of the implementation index. Before running the PCA, adequacy of sample size was determined using the KMO measure of sampling adequacy and Bartlett’s test of sphericity. Number of factors to retain was decided on two main criteria: Eigen value > 1 and Cattell Scree plot. Only those items were retained that had a KMO value > 0.5 in the anti-image of the correlation matrix, a communality > 0.2 and factor loading > 0.32. Internal consistency of the implementation index was measured using the Cronbach’s alpha considered acceptable at 0.60. PCA and reliability analysis were conducted using the FACTOR programme.
32
Results
33
Characteristics of Peer Volunteers (PVs)
34 35
Basic demographic characteristics of peers are given in Table 2. Average competency of peers was 82.67% (SD=6.45), number of sessions delivered were 92.15% (SD=6.51), duration of
9
1 2
sessions 81.23% (SD=9.72) and number of supervised sessions attended were 64.62% (SD=24.15).
3 4 5
Association between implementation strength index and clinical outcomes
6 7 8 9 10 11 12 13
The implementation strength index for THPP ranged from 77% to 96% at the level of individual peers, corresponding to a good level of implementation. There was no significant association between PHQ-9 scores and implementation strength index (p= 0.805), as indicated in Table 3. A one-unit increase in implementation strength resulted in a decrease of 0.03 units in PHQ-9 scores. Although the correlation was statistically non-significant, a weak inverse relationship was evident between implementation strength index and the severity of depressive symptoms. However, implementation index was significantly correlated with the disability measure (p=0.002).
14 15 16 17
Table 3 demonstrates a strong relationship between measure of disability and implementation index of THPP (p= 0.002). A unit increase in implementation strength led to 0.44 points decrease in disability scores. Peer level scatter plots with fitted regression lines between changes in implementation index of THPP and depression and disability scores are shown in figure 2 and 3.
18
Dimension reduction & internal consistency
19 20 21 22 23 24 25 26 27 28
Principal component analysis (PCA) was performed to affirm the factor validity of the implementation index. The study sample was found to have a slightly lower Kaiser-Meyer-Olkin measure of sampling adequacy (0.57) and a statistically significant Bartlett’s test of sphericity (X2=8.0, P=0.04). Based on the criteria of Eigen value > 1, Cattell scree plot and parallel analysis, only one factor was retained. This factor explained 49.43% of the cumulative proportion of the variance in implementation strength index. All items except the duration of session was found to have a communality value > 0.20 and factor loadings > 0.32 (Table 4). The duration of sessions yielded a communality value of 0.002 and factor loading of 0.04, hence, it was excluded from the final analysis. Alpha coefficient value for the implementation strength index comprising the three items was 0.49 which was lower than the accepted value of 0.60.
29
Discussion
30
Summary of results
31 32 33 34 35
This article reports the development of first index to gauge the implementation strength of a peer mediated perinatal mental health intervention in a low- and middle-income country. Exploratory factor analysis and reliability indices depicted a valid and reliable implementation strength index comprising of three service delivery level indices: competency levels, average number of sessions and number of supervised sessions. Inverse relationship between implementation 10
1 2
strength index and total scores on WHODAS was observed, however, it yielded no significant association with scores on PHQ-9.
3 4 5 6
Development of implementation index
7 8 9 10 11 12 13 14 15 16 17 18 19 20 21
The development of the implementation index was done in accordance with our logic model and an extensive consultation process with the intervention developers and delivery team. These four service provider level indicators were identified as crucial components of an implementation index. These are mainly competency of delivery agents, dosage of interventions, number of sessions delivered and duration of each session. One of the key barriers in the choice of indicators for implementation strength was the lack of literature relevant to psychological interventions. Therefore, implementation indices developed for public health programs in other domains were consulted. A few of these programs were summarized and critically evaluated in two key literature reviews (Schellenberg et al., 2012; Hargreaves et al., 2016). Methodological
22
Statistical validation
23 24 25 26 27 28 29 30 31 32 33 34 35 36 37
The development procedure of the implementation index ensured inclusion of service delivery agents and intervention experts, ensuring a good face validity. After the testing of this implementation index in the field, its dimensionality and content validity were tested using several statistical validation procedures. Exploratory factor analysis was done to ascertain the dimensionality of the implementation index. It revealed a unidimensional factor structure explaining 49% of the variance in the index scores. However, it deemed only three out of four of the indicators to be suitable for calculating the overall implementation index; leading to exclusion of “duration of sessions” component from the implementation index. Reliability analysis revealed an unacceptable internal consistency of the IS index. This may be due to several reasons. Firstly, Cronbach’s alpha value is dependent on the number of items in a scale which disadvantages the use of an index based on only three items (University of Virginia Library, 2015). In addition, competency and supervision are strongly related to quality of the intervention than number of supervised sessions or duration of session. Hence, the items or constructs included in the implementation index were quite heterogeneous, thus, further lowering the alpha value. This has been shown in several psychometric studies where heterogeneity in
gaps, limitations and a lack of consensus on defining and measuring implementation were identified in these two reviews. These two reviews also developed a framework for future indices of
implementation strength and provided several case studies highlighting their use of public health programs. Most of the programmes fulfil the needs of a project and cannot be generalised in other settings. Moreover, only a few of the programs provided validation procedures for their tools or associations between implementation processes and outcomes.
11
1 2
items led to poor Cronbach’s alpha values (Ruuttu et al., 2006; Andrews et al., 1993; Andrews et al.,1989).
3
Association of implementation strength index with depressive symptoms and disability
4 5 6 7 8 9 10 11 12 13
Albeit the implementation index was a significant predictor of WHODAS scores, it did not yield a significant association with PHQ-9 scores. However, the peer volunteers exhibited good scores on implementation indices, showing little variability in the implementation strength. There could be a myriad of reasons for this statistical insignificance. Firstly, the implementation indices chosen may be suitable for exploring disability but not depressive symptoms among pregnant women. Secondly, the association between the THPP intervention and PHQ-9 may be driven by other constructs of implementation. We encourage future research for identifying more constructs of implementation that are strongly associated with the outcomes. Thirdly, the use of simplistic scoring matrix for calculation of implementation strength is yet another limitation that may have yielded non-significant results.
14 15 16 17 18 19 20 21 22 23 24
It is suggested that future studies should use more transparent weighting and scoring systems (J. Schellenberg, Bobrova, N., Avan, BI, 2012). Hargreaves et al suggested this by creating a more representative composite scoring system, based on factor analysis loadings of individual components or by conducting a regression analyses to determine their relative weights (Hargreaves et al 2016). Lastly, this non-significant association between PHQ-9 scores and implementation index may also reflect the ineffectiveness of the THPP intervention in maintaining remission of depressive symptoms at six-month follow-up in the parent trial (Sikander et al., 2019). The THPP program is based on an evidence-based CBT model, however, significant challenges exist in its delivery by peer volunteers in Pakistan. It should, however, be noted that successful trials have previously been conducted where lady health workers were employed as delivery agents of THP intervention.
25
Rationale for mixed findings
26 27 28 29 30 31 32 33 34
The answer for the mixed findings for depression severity and disability may be due to the complex nature of the relationship between these two constructs (Bruce, 2000). This has been documented in previous research showing heterogeneous trajectories of depressive symptoms and poor psychosocial functioning (Bruce, 2001; Yaroslavsky et al. 2013; Peer and Spaulding 2007). Measures of disability such as the WHODAS assess psychosocial disability as perceived by the study participants. Further research is encouraged to explore the rationale for the usefulness of THPP in reducing disability but not depressive symptoms. Unpacking of the THPP intervention into its specific and non-specific therapeutic components may be the key to finding this answer (Fixsen, Naoom, Blase, & Friedman, 2005).
35
Direction for future research
36 37
It would be ideal to use individual participant level data instead of calculating means for participants assigned to one peer in future studies. Further insights into key components of the 12
1 2 3 4 5 6 7 8
intervention to develop implementation indices that are more sensitive to outcome measures is highly recommended. A limitation in this study, was the use of session logs maintained by peers themselves for recording dose and duration of the THPP session. This may have introduced a reporting bias in reporting of these two indicators. However, literature does support the use of such self-reported and self-documented measures despite its limitations (Grizzard, Bartick, Nikolov, Griffin, & Lee, 2006). Future research studies should focus on identifying more components of implementation strength along with robust method for measuring them. This might be helpful to identify which constructs are strongly correlated with the outcomes.
9
Conclusion
10 11 12 13 14
Development of implementation index for evidence-based task-shifted psychological interventions is necessary to aid in scale up of these programmes. Policy makers and local governments can use these findings to monitor their implementation strength and impact on clinical outcomes. Developing a measure for assessing implementation strength of THPP will also be a useful addition to monitor packages of intervention being implemented in the LMICs.
15
Ethical considerations
16 17 18 19
The development of implementation index for THPP was based on existing data collected as part of the randomised trial. The trial had ethical clearance from, the Institutional Review Board of Human Development Research Foundation (HDRF) Pakistan, and the University of Liverpool, UK.
20 21
Conflict of Interest
22
No competing interests reported by authors.
23
Acknowledgement
24 25
We acknowledge the contribution of all peer volunteers for their assistance and support in the field.
26
Funding
27 28
This research did not receive any grant/funds from any agency in the public, commercial or notfor-profit sectors.
29
13
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45
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1 2
Table 1: Logic model Inputs Master trainer
Intervention facilitators
Intervention Package (THPP)
Processes Collaboration with primary health care system
Outputs Competency of the Peer Volunteers
Identification of Peer Volunteers
Intervention delivered to mothers
Training and supervision of Peer Volunteers
Attendance of the PVs in supervisions
Funds
Outcomes Reduction in depressive symptoms (PHQ-9 scores at 6th month post childbirth)
Impact Improved maternal mental health
Reduction in disability (WHO-DAS scores at 6th month post childbirth)
3 4 5
Variables
(%)
Age (mean, [SD]) 18-25 26-35 36 - 45
30 [5.7] 7 (15.6%) 29 (64.4%) 9 (20%)
2:
6
Demographic
7
characteristics
8 9 10
18
Table
of
Peer Volunteers
(n=45)
Highest level of education completed (mean, 12 [2.1] 22 (49%) [SD]) Secondary 9 (20%) Intermediate 14 (31%) Graduate Married 33 (73.3%) Single 10 (22.2%) Divorced 2 (4.5%) No of children (mean, SD) 2 [2.0]
1 2 3 4
5 6 7 8 9 10 11
Table 3: Association between PHQ-9 and Implementation Strength Index (n=45) Implementation strength index Predictor
SE B
β
F
R2
p
.105
-.038
.061
.001
.805
Model 1
PHQ-9
Model 2
19
WHO-DAS
.31
-.44
10.34
.19
.002
1
Note: PHQ-9=Patient Health Questionnaire; WHO-DAS=World Health Organization Disability
2
Assessment Schedule
3 4 5 6 7 8 9
Table 4: Factor analysis for Implementation Strength Index Variable
Factor loading
Communality
Competency
0.82
0.67
Average number of sessions
0.57
0.32
Number of supervised
0.70
0.49
sessions 10 11 12
20
Figure 1: Cascade model of training and supervision
Master Trainer in UK
Local Trainers in Pakistan
Volunteer Peers in rural Rawalpindi
Women with perinatal depression in villages
Figure 1: Association between PHQ-9 and ISI
Association between PHQ-9 and ISI (n=45) 14
PHQ-9 scores
12 10 8 6 4 2 0 75
80
85
90
ISI
95
100
Figure 3: Association between WHO-DAS and ISI
Assocation between WHO-DAS and ISI (n=45) 40
WHODAS scores
35 30 25 20 15 10 5 0 75
80
85
90
ISI
95
Highlights • • • •
Implementation strength index is constructed based on four key constructs. Strength reflected provider competence and contact intensity. Index showed signification association clinical outcomes. Creating a single index may facilitate analyses.