Contemporary Clinical Trials 90 (2020) 105954
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Development and evaluation of an 1-day Acceptance and Commitment Therapy workshop for Veterans with comorbid chronic pain, TBI, and psychological distress: Outcomes from a pilot study
T
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Lilian Dindoa,b, , Adrienne L. Johnsonc,d, Brent Langb, Merlyn Rodriguesb, Lindsey Martina,e, Ricardo Jorgea,b a Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, United States of America b Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States of America c William S. Middleton Memorial Veterans Hospital, Madison, WI, United States of America d Center for Tobacco Research and Intervention, University of Wisconsin, Madison, WI, United States of America e Department of Medicine, Baylor College of Medicine, Houston, TX, United States of America
A R T I C LE I N FO
A B S T R A C T
Keywords: Traumatic brain injury Acceptance and commitment therapy Veterans Brief psychotherapies Qualitative research Quantitative evaluation
Objectives: To 1) develop and refine a 1-day trans-diagnostic psychotherapeutic “ACT on Life” workshop tailored for Veterans with mild traumatic brain injury, stress-based psychopathology, and pain; 2) examine the feasibility, acceptability, and preliminary effects of this intervention. Setting: A Veterans Health Administration medical center. Participants: Veterans returning from Operations Iraqi Freedom, Enduring Freedom, and New Dawn with mild TBI, stress-based psychopathology, and chronic pain. Design: Phase I involved development of the intervention by experts and subsequent refinement based on Veteran feedback (N = 11). Phase II was a pilot randomized controlled trial comparing the effects of the revised intervention (N = 20) to treatment as usual (TAU; N = 12). Main measures: For phase I, qualitative feedback at 2 weeks and 3 months post-workshop was obtained from Veterans. For phase II, quantitative measures included the PTSD Checklist, Depression Anxiety and Stress Scale, Military-to-Civilian Questionnaire, WHO-Disability Assessment Schedule, Brief Pain Inventory, Acceptance and Action Questionnaire. Results: Veterans found the workshop acceptable, innovative and useful. Quantitative data from phase II suggested that participants in the ACT group, relative to TAU, showed improvement in psychiatric symptoms, functioning, and reintegration 3 months post-workshop. Unexpectedly, pain interference was lower in the TAU group at follow-up. Conclusions: Preliminary results support the feasibility, acceptability, and promising effects on psychological distress and community reintegration of this 1-day, transdiagnostic workshop for Veterans. Future research examining the effectiveness of this workshop with a larger sample size is necessary.
1. Introduction Traumatic brain injury (TBI) is the “signature wound” of Veterans of Operations Iraqi Freedom, Enduring Freedom, and New Dawn (OIF/ OEF/OND), with up to 20% of 2 million deployed Veterans experiencing post-concussive symptoms [1]. Among those with TBI, most also experience a comorbid mental health disorder, including depression,
posttraumatic stress disorder (PTSD) and/or other anxiety disorders (stress-based psychopathology), as well as chronic head, neck or back pain [2,3]. An estimated 42% of all OIF/OEF Veterans have the “polytrauma” of chronic pain, PTSD and mild TBI (mTBI) [4]. Suboptimal management of comorbid TBI, mental health disorders and pain results in increased morbidity, mortality and suicide risk and significantly decreased quality of life [5–7]. Unfortunately, Veterans are
⁎ Corresponding author at:Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, United States of America. E-mail address:
[email protected] (L. Dindo).
https://doi.org/10.1016/j.cct.2020.105954 Received 18 September 2019; Received in revised form 22 January 2020; Accepted 30 January 2020 Available online 04 February 2020 1551-7144/ Published by Elsevier Inc.
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2.3. Participants and procedure
often reluctant to seek treatment for mental health-related issues, due to beliefs that one should overcome psychological difficulties on his/her own and concern that receiving such care would negatively impact their careers [8]. Even among Veterans who start mental health treatment, only a small minority complete a recommended course of evidence-based therapy. Practical barriers, including time constraints, distance from a treatment facility, and competing priorities, are prevalent [9,10]. Given the elevated prevalence and related negative outcomes of chronic pain, stress-based psychopathology and TBI, along with low treatment rates among Veterans, it is important to identify efficient, accessible and transdiagnostic (i.e., applies to more than 1 diagnosis) treatments Veterans will use. Acceptance and Commitment Therapy (ACT) is a transdiagnostic intervention model that can address a range of psychosocial and behavior-related issues Veterans face by targeting key common factors, in particular, avoidance-based coping [11]. ACT helps patients overcome avoidance by promoting acceptance-based coping and engagement in meaningful life activities. From this perspective, for example, Veterans are asked to think about their “post-deployment mission(s)” and the value of engaging in actions that fulfill their mission, even when it may be difficult. With established efficacy in treating depression, anxiety and pain [12–14], ACT has been effectively implemented in both civilians and Veterans and delivered in various formats, including cost- and time-efficient 1-day group workshops [15]. Providing a 1-day ACT “workshop” for Veterans with mTBI, mental health disorders, and chronic pain allows unitary, comprehensive care for their emotional, physical and cognitive symptoms. Presenting the treatment as a “workshop” rather than “therapy” is also better suited for Veterans who may not be explicitly seeking specialized mental health care [8]. Finally, a 1-day workshop ensures treatment adherence and completion, the lack of which is often the greatest obstacle to effectively delivering mental health services [16]. This study had 2 phases and aims. In phase 1, the aim was to develop and refine a 1-day, transdiagnostic group workshop based on ACT (i.e. “ACT on Life”) tailored for OIF/OEF/OND Veterans with mTBI, stressbased psychopathology and chronic pain. In phase II, the aim was to conduct a pilot randomized controlled trial (RCT) to examine acceptability, feasibility and preliminary effects of the revised “ACT on Life” workshop, compared to treatment as usual (TAU) on stress-based symptoms of psychopathology, psychosocial functioning and pain interference. It was hypothesized that, at 3-month follow-up, Veterans randomized to “ACT on Life” would improve more in overall distress, functioning, and pain interference than the TAU group.
Veterans who had deployed to OEF/OIF/OND were recruited via advertisements and oral presentations at several locations, including the Michael E. Debakey Veterans Affairs (VA) Medical Center, community-based outpatient clinics, and local community outreach locations (i.e., Vet centers, universities, etc.). Veterans first completed a brief screening and met cutoffs if they: 1) had deployed to Iraq or/and Afghanistan, 2) reported close blast exposure and/or mechanical trauma to the head during their lifetime, 3) reported chronic pain at a level of 3 or higher on a 10-point scale, 4) had no history of schizophrenia or bipolar disorder, and 5) had psychotropic medications stable for at least 4 weeks. Those who screened positive completed an in-depth assessment and had to meet the following inclusion criteria: [1] diagnosis of an mTBI according to criteria provided by Department of Veterans Affairs/Department of Defense Clinical Practice Guidelines and further categorized by the clinician-administered Boston Assessment of TBI – Lifetime [18]; [2] diagnosis of current major depressive disorder, generalized anxiety disorder, or PTSD on the Structured Clinical Interview for the Diagnostic & Statistical Manual, Fourth Edition (SCID-I) [19] or the Clinician Administered PTSD Scale [20]; [3] no current suicidal or homicidal ideation; [4] negative status for diagnosis of substance dependence in the past year, based on the SCID-I; [5] negative status for lifetime diagnosis of psychotic disorder on the SCID-I. 2.4. ACT workshop The workshops were led by 2 clinical psychologists with extensive experience in ACT (author LD was always present). Each workshop included 4–8 Veterans, lasted approximately 5 h, and incorporated ACT and psychoeducational content. The workshop, described in pragmatic detail by Dindo and colleagues, included didactic and experiential exercises [17]. The ACT portion of the workshop (4 h) included Behavioral Change Training (2 h), which involved 1) teaching Veterans how to recognize ineffective patterns of avoidant coping and behaviors; 2) exploring and identifying personal values; 3) setting specific, trackable goals aimed at fostering these values despite adversity and challenges, as well as Acceptance and Mindfulness Training (2 h), which involved 1) teaching new ways to manage troublesome thoughts, feelings and physical sensations to prevent their interference with valued life directions; and 2) teaching ways to cultivate present moment awareness. The psychoeducational component of this workshop (1 h) included 1) reviewing the symptoms, and overlap of symptoms, of common problems among OIF/OEF Veterans (i.e., mTBI, PTSD, major depressive disorder, anxiety, chronic pain); 2) discussing resources available to Veterans. Illness education is helpful for patients who often have surprisingly little understanding of their illness, the rationales of its treatment, and their own ability to influence its course. For example, providing education regarding the characteristics and clinical course of mTBI decreases anxiety and negative expectations of recovery from the event. Veterans received printed copies of ACT and psychoeducation manuals highlighting and elaborating concepts discussed in the workshop. Some research suggests that men may do better in single-gender groups [21]. Further, the multidisciplinary team of expert VA providers who were involved in treatment development encouraged single-sex groups for this Veteran population. Thus, the ACT workshops were composed of male Veterans only.
2. Phase 1 2.1. Methods This study was fully approved by an Institutional Review Board, and all Veterans provided written informed consent. The study is also registered in clinicaltrials.gov (NCT02844946). 2.2. Development of protocol An ACT patient manual previously developed by Dindo and colleagues [17] was modified for Veterans with mTBI, stress-based psychopathology and chronic pain by adding more Veteran-centered language and exercises related to experiences of OIF/OEF/OND Veterans with the triad of difficulties. Next, a multi-disciplinary team of a clinical psychologist, neuropsychiatrist, cognitive psychologist, chaplain and anthropologist provided extensive feedback on the exercises and examples to enhance relevance to the difficulties, experiences and lives of Veterans with polytrauma. The intervention was then piloted with 11 Veterans with the polytrauma clinical triad (see inclusion/exclusion criteria below) who provided qualitative feedback on the intervention and materials 2 weeks and 3 months after the workshop,
2.5. Interviews and follow-up assessments Two weeks and three months post-workshop, the project coordinator conducted 15- to 20-min qualitative, semistructured phone interviews with each participant (interview guides available as appendix). 2
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class to solidify and reinforce concepts learned, 2) inclusion of a Veteran in the research team, 3) greater utilization of manuals during the workshop, 4) greater use of military language, and 4) inclusion of more community resources and complementary medicine treatment options. At 3 months, qualitative data were sorted into 6 unique domains (for details, see Supplement, Summary of 3-month postworkshop qualitative feedback). The domains were 1) mental and physical health past 3 months, 2) most memorable workshop experience, 3) barriers and facilitators to using skills, 4) use of ACT Manuals since workshop, 5) suggestions for workshop improvements, and 6) interest in similar workshops. Overall, many Veterans described better management of their physical and emotional health, but some continued to struggle. The group atmosphere, exercises, and various ACT metaphors remained salient at this time. Application of skills learned varied, but the practical demonstration of skills in the workshop was consistently reported as helpful. Suggestions for improvement included [1] greater use of military terminology in discussion and materials, [2] follow-up sessions or a multiple-session format, [3] items to help remember key concepts (e.g., flashcards, motivational magnets), [3] identification of goals for individual Veterans and homework assignments at the end of workshops and [4] an alternate venue (e.g., outside the VAMC for those who do not like to go to a VAMC; at community-based outpatient clinics for those who live far from the main VAMC). Veterans expressed interest in attending future workshops.
2.6. Qualitative data analytic plan We used rapid qualitative analysis, a systematic and rigorous process, to succinctly condense and review data to inform workshop implementation [22]. A qualitative methodologist (author LM) trained the project coordinator in rapid analysis. For 2-week interviews, both analysts worked together to create a summary template, containing key domains derived from the interview guide. Analysts then independently summarized 3 transcripts to test usability of the summary template and met in consensus meetings to resolve discrepancies. The project coordinator then summarized the remaining 9 transcripts independently. Data were placed in a matrix display to identify key findings across the sample for each domain [23]. The project coordinator created a summary document for each domain to succinctly present data for review, which was subsequently reviewed by the qualitative methodologist and updated, based on feedback. Working independently, the project coordinator followed the steps outlined above (i.e., developing/testing a summary template and creating transcript summaries, matrix and domain summaries) for the 3-month interviews. The qualitative methodologist also reviewed and provided feedback on the matrix and domain summaries at 3 months. 3. Results In Phase I, 2 ACT workshops were conducted with 11 OIF/OEF Veterans meeting the inclusion/exclusion criteria listed above (Group 1 had 5 men, and Group 2 had 6 men). The average age of Veterans was 37.5 (SD = 6.1); 45% were Hispanic, 36% were African American, and 18% were white; 45% were currently married; average amount of education was 14.3 (SD = 2.1) years; 45% were currently employed part- or full-time; 73% were former members of the army; average number of deployments was 2.6 (SD = 1.9). In terms of past month psychiatric diagnoses, 10 of the 11 met criteria for PTSD, 4 met criteria for major depressive episode, and 1 had generalized anxiety disorder. All met criteria for an mTBI (2 were Stage 1, 4 were stage II, and 5 were stage III).
3.2. Adaptations before RCT trial Several adaptations were made to address concerns and suggestions from the pilot phase. These included [1] greater use of military terminology, [2] inclusion of a Veteran research collaborator during workshops, [3] adjustment of timing to allow easier access to parking at the workshop facility (i.e., VAMC), and [4] increased emphasis on skills during the workshop and encouragement to use skills learned after the workshop. The length (1 day) and location (VAMC) of the workshop remained unchanged because the second study aim was to evaluate the feasibility and acceptability of this format and standard treatment location in an RCT.
3.1. Qualitative results
4. Phase 2 - RCT
The 2-week post-workshop feedback was organized into 10 unique domains derived from the interview guide (for details, see Supplement, Summary of 2-week post workshop qualitative feedback from Veterans). The domains were 1) reasons for participating/ expectations, 2) workshop length and amount of information presented, 3) ACT instructor impressions, 4) group setting, 5) exercise/ skills/strategies learned on day of workshop, 6) manual content, 7) general descriptions of managing life/stress since workshop, 8) use of specific ACT skills since workshop, 9) use of ACT treatment manuals since workshop, and 10) telling others about ACT workshop. Overall, Veterans participated in the workshop because they wanted to learn new ways to cope with their health issues (i.e., PTSD, TBI) and to help other Veterans. They preferred the 1-day length over a longer course but also desired to extend the workshop to better “dissect” content and feel less rushed. They appreciated and felt heard by the instructor, despite her nonVeteran status and felt “safe” and comfortable expressing experiences and emotions, contrary to their usual experience in groups. Veterans particularly enjoyed the camaraderie with other Veterans in the group and being in a “male-only” setting. They indicated that the focus on “values” helped raise awareness of the importance of living a life consistent with what matters most. The practical, “hands-on” exercises were most effective in teaching new coping strategies. Veterans reported similar levels of stress as before the workshop but noted more awareness of stressors and greater focus on valued activities. They found the workshop helpful, motivational and informative and would recommend it to other Veterans but noted its lack of specific goal-setting strategies. Suggestions for improvement included 1) a follow-up
4.1. Method 4.1.1. Participants and procedure Inclusion, exclusion, and recruitment methods were the same as in Phase 1. Of 177 Veterans completing screening, 60 met screening criteria and were eligible to complete an in-person baseline assessment. Of these, 52 completed the baseline assessment; and 42 met inclusion criteria. (See Fig. 1). Following the baseline interview, participants were randomly assigned to ACT (n = 27) or to TAU (n = 12). A 2:1 ACT to TAU ratio assignment ratio was used in order to increase the number of patients with active treatment for estimating the within (treatment) group effect size, while still maintaining adequate power. Of 27 Veterans invited to the ACT workshop, 20 attended (74.1% attendance rate; Fig. 1). The TAU group followed standard care through the VHA system, including continued utilization of VHA psychiatric and medical services. Demographic information for both groups appears in Table 1. Content and structure of the workshop remained largely similar to those of the pilot phase, with the addition of adaptations noted above. Veterans randomized to ACT completed qualitative, semistructured interviews at 2 weeks and 3 months postworkshop, using the same guides developed for Phase 1. 4.1.2. Measures The following assessments were completed at baseline and 3-month follow-up. For symptoms of psychopathology, the PTSD Checklist3
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Fig. 1. CONSORT diagram of the flow of participants in the RCT. Note: ACT = Acceptance and Commitment Therapy; TAU = Treatment as Usual.
items are rated on a 7-point scale, ranging from 1 (“never true”) to 7 (“always true”), with higher scores reflecting greater inflexibility. Example items include, “Emotions cause problems in my life,” and “My painful memories prevent me from having a fulfilling life.” It has been shown to have good internal consistency and validity and also to mediate behavioral outcomes in ACT interventions [31].
Civilian Version (PCL-C) is a 17-item self-report questionnaire assessing the presence and severity of DSM-IV symptoms of PTSD during the past month. It has demonstrated good reliability and validity and is regularly used in clinical practice [24]. The Depression Anxiety and Stress Scale (DASS-21) is a 21-item self-report questionnaire that includes 3 subscales to assess frequency of depression, anxiety and stress over the past week. Total scores are calculated by summing the 3 subscale scores. It has demonstrated adequate construct validity and internal consistency and has been used extensively with military personnel and individuals with TBI [25] [26]. Other instruments were used to measure functioning. For example, the Military to Civilian Questionnaire (M2C-Q) is a 16-item, self-report measure of post deployment community reintegration with demonstrated good construct validity and high internal consistency [27]. Higher scores reflect greater difficulty in reintegration over the past month. The World Health Organization-Disability Assessment Schedule 2.0 (WHODAS-2) is a 36-item, self-report measure of psychosocial functioning and disability due to health conditions. It demonstrates good reliability, validity and sensitivity to change after treatment. Higher WHODAS-2 total scores reflect greater functional disability [28]. To measure pain, the Brief Pain Inventory (BPI) assesses location, intensity and interference of pain. It contains 17 items and demonstrates good reliability and validity [29]. The Acceptance and Action Questionnaire-II (AAQ-II) is an ACTspecific self-report measure of psychological inflexibility [30]. Seven
4.1.3. Quantitative data analytic plan Group differences between the ACT and TAU groups on demographic variables were examined, using Chi-square tests and independent samples t-tests as appropriate (Table 2). General Linear Mixed Modeling was used to compare changes in outcomes between the ACT and TAU groups from baseline to 3-month follow-up. Separate models were constructed to examine changes in distress (DASS-21), PTSD symptoms (PCLC), functioning (M2CQ, WHODAS-II), and pain interference (BPI). Full-information maximum likelihood estimation was used to estimate missing values for dependent variables. Due to the small sample size, we report mean differences, confidence intervals and effect sizes for quantitative outcome data. The analyses were conducted using PROC Mixed in SAS 9.4. 5. Results 5.1. Qualitative 2-week feedback Feedback in the RCT was very similar to that provided in the pilot 4
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Table 1 Demographic characteristics, military history and clinical characteristics of treatment and control groups at baseline.
Age mean (SD) Ethnicity, % White African American Hispanic/Latino Othera Marital status, % Married Otherb Years of education mean (SD) Employment status, % Employed (Full or parttime) Otherc Military branch % Army Marine corps Otherd Number of deployments mean (SD)e Past month diagnoses, % Posttraumatic stress disorderf Major depressive episodeg Generalized anxiety disorderg Most severe traumatic brain injuryh Mild, Stage I Mild, Stage II Mild, Stage III Currently in psychotherapy, % yes Currently taking psychotropics, % yes
ACT on Life (n = 20)
Treatment As Usual (n = 12)
P value
37.7 (6.3)
34.7 (5.8)
0.19 0.99
42 21 21 15
42 17 25 17
68 32 14.1 (1.8)
50 50 14.3 (1.6)
47 53
58 42
47 26 26 2.2 (1.3)
50 25 25 2.4 (1.1)
0.65
63 47 21
75 67 8
0.490 .290 .35
26 53 21
25 58 17
63
50
0.47
26
33
0.68
Table 2 Means and SEs for participants in ACT on Life and Treatment as Usual conditions at baseline and 12-week follow-up. ACT (n = 20)
TAU (n = 12) Effect Size
DASS-21 Total Baseline 53.4 ± 6.3 59.7 ± 8.0 3-month follow-up 42.7 ± 6.3 65.6 ± 8.3 d = 0.68 PCL Total Baseline 56.3 ± 4.3 56.2 ± 5.4 3-month follow-up 49.2 ± 3.8 54.4 ± 4.8 d = 0.33 WHODAS Total without work 40.9 ± 5.2 40.8 ± 7.1 Baseline 3-month follow-up 38.3 ± 5.6 41.7 ± 7.7 d = 0.30 Military-to-Civilian Total Baseline 2.03 ± 0.21 2.01 ± 0.27 3-month follow-up 1.81 ± 0.22 2.14 ± 0.30 d = 0.47 BPI Pain Severity Baseline 5.5 ± 0.4 4.5 ± 0.5 3-month follow-up 5.3 ± 0.5 4.2 ± 0.7 d = 0.10 BPI Pain Interference Baseline 5.0 ± 0.7 5.5 ± 0.8 3-month follow-up 5.6 ± 0.6 4.6 ± 0.8 d = 0.78 Acceptance and Action Questionnaire Baseline 27.3 ± 2.8 29.5 ± 3.7 3-month follow-up 22.8 ± 2.8 30.3 ± 3.8 d = 0.56
0.31
0.72 0.55
0.81
Note: ACT = Acceptance and Commitment Therapy; TAU = Treatment as Usual; DASS-21 = Depression, Anxiety, and Stress Scale; PCL = Post-Traumatic Stress Disorder. Checklist; WHODAS=World Health Organization Disability Assessment Scale; BPI = Brief Pain Inventory.
0.94
of learned skills to Veterans' life conditions (i.e., physical and emotional stressors) and greater utilization and success of skills learned (e.g., grounding exercises, cognitive defusion strategies). Despite this, Veterans desired even more focus on these practical skills and made additional suggestions for utilization of skills following the workshop. Other novel suggestions for improvement included using workshop completers as recruiters for future workshops, focusing more on pain management, and providing a certificate of completion at the end of the workshop. Veterans in the RCT did not recommend greater use of military terminology.
Note. Percentages may not add to 100% due to rounding. a Other included Biracial, Asian, and/or Native-American. b Other included Single, Widowed, or Divorced. c Other included Student, Unemployed, Disabled, or Retired. d Other included Air Force, Navy, National Guard, and/or Coast Guard. e Self-repoted total of both combat and non-combat deployments. f Based on Clinician Administered PTSD Scale for Diagnostic & Statistical Manual, Fourth Edition. g Based on the Structured Clinical Interview for Diagnostic & Statistical Manual, Fourth Edition. h Based on the Boston Assessment of Traumatic Brain Injuries-Lifetime.
5.3. Quantitative results Means and standard errors for key dependent measures at baseline and 3-month follow-up are presented in Table 2. Compared to those in the TAU group, Veterans in the ACT group showed positive trends in the reduction of combined symptoms of anxiety, depression and/or stress (DASS-21 Total scores, Mdifference = −16.55, 95% CI [−35.9, 2.8], d = 0.68, p = .09) and in self-reported past-month posttraumatic symptoms (PCL-C Total Scores, Mdifference = −5.1, 95% CI [−17.1, 7.0], d = 0.33, p = .39). In addition, at 3-month follow-up, Veterans in the ACT group showed positive trends towards decreases in disability compared to those in the TAU group (WHODAS-II Total scores, Mdifference = −4.2, 95% CI [−15.2, 6.9], d = 0.30, p = .44). Furthermore, in terms of military-to-civilian reintegration, Veterans in the ACT group demonstrated greater reductions in difficulties than those in the TAU group (M2C-Q, Mdifference = 0.36, 95% CI [−1.6, 2.3], d = 0.47, p = .23). It is noteworthy that participants in ACT exhibited positive trends in the improvements in psychological flexibility, the proposed processes targeted in ACT treatments; whereas participants in the TAU group did not (AAQ Mdifference = −5.4, 95% CI [−13.0, 2.3], d = 0.56, p = .16). There were no meaningful differences at the 12-week follow-up between Veterans in the ACT and TAU groups in pain severity (BPI-Pain Severity subscale, Mdifference = 0.12, 95% CI [−1.07, 1.32], d = 0.10, p = .50). Unexpected and contrary to our hypotheses, the TAU group exhibited a greater drop in pain interference than the ACT group (BPI-
across all domains (see Supplement 1). Novel themes primarily highlighted participants' recognition and acceptance of adaptations (e.g., alternate workshop times, demonstration of multiple skills in group) made by the study team. Suggestions for improvement included highlighting differences between this and other psychotherapy groups offered at the VHA and providing greater information on available resources within and outside the VA system (e.g., psychotherapy groups, complementary medicine, VA patient advocates, etc.). Lastly, Veterans in the RCT group noted specific improvements in areas of functioning (e.g., time management, communication, patience) and utilization of skills, despite their consistent stress levels and cognitive barriers related to their TBI (e.g., memory loss).
5.2. Qualitative 3-month feedback Feedback in the RCT was similar to pilot feedback, except for specific suggestions for workshop improvements and improved application of learned skills (see Supplement 2). Novel themes included adaptation 5
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Contrary to hypotheses and previous literature highlighting the benefits of ACT for chronic pain symptoms [37], Veterans in the TAU group exhibited greater reduction in pain interference than those in the ACT group. Given the small sample size of this pilot trial, it is important for this unexpected finding to be explored further in larger, well-powered studies. Furthermore, as suggested by the Veterans' qualitative responses in the RCT, we may need to modify workshop materials to focus more on chronic pain symptoms these Veterans are experiencing. Overall, our results support the feasibility and acceptability of a 1day, transdiagnostic workshop for Veterans with the polytrauma clinical triad. Furthermore, preliminary positive effects of the workshop were found for all outcome variables except pain severity and pain interference. These preliminary results are exciting and warrant further investigation, given the high rates of physical and psychiatric comorbidity [4] and low rates of treatment utilization [8,38] among these Veterans. Additionally, the brief nature of this workshop effectively removes the potential for treatment dropout, a main deterrent to effective mental health care [16]. Finally, this study supports concurrent treatment of these coexisting medical and psychiatric conditions, with the potential to decrease patients' burden and cost of attending multiple visits. To our knowledge, no other studies examine concurrent treatment of mTBI, stress-based psychopathology and chronic pain. As this was a pilot study, one limitation is the small sample size and resulting low power, which led us to present mean differences and effect sizes. Nonetheless, the moderate effect sizes found for the DASS-21 total score, PCL, M2CQ, and AAQ are similar to those reported in a meta-analysis looking at the effectiveness of ACT compared to other treatments/wait-list on psychological outcomes in those with acquired brain injury [39]. Although our findings are promising, an adequately powered RCT examining the effectiveness of this brief ACT workshop for Veterans with the polytrauma clinical triad is necessary. Future research with larger samples will also allow mediation analyses, important for developing and adapting interventions for difficult-to-treat populations. Another limitation is the use of a relatively short (3month) follow-up period. Future studies should examine functioning over a longer period to determine whether the positive effects we found here decay over time, to inform timing of potential booster sessions. With the growing number of female military service members, it will also be important for future studies to assess the value of this intervention on female Veterans with polytrauma. Strengths of our study include its longitudinal nature, which allowed examination of the prospective impact through a 3-month follow-up. Furthermore, our use of validated, semistructured diagnostic interviews (i., BAT-L [18], Clinician Administered PTSD Scale [20], SCID-I [19]) assured that Veterans met eligibility criteria and allowed comprehensive assessment of their mental and physical health. Another strength was our use of qualitative and quantitative data, allowing us to collect feedback on the development and feasibility of this study and support preliminary effects of this novel treatment. Conclusion. Given the high prevalence of co morbid mental health problems and pain among combat Veterans with mTBI, adapting evidence-based treatments that reach and are acceptable to this Veteran population and address psychosocial distress and disability is of paramount importance. The results of this pilot trial, which suggests that a 1-day ACT workshop can have a positive impact on Veterans with polytrauma, merits further investigation.
Pain Interference subscale, Mdifference = 1.48, 95% CI [−0.36, 3.33], d = 0.78, p = .03). 6. Discussion Our findings support the feasibility and acceptability of an intensive 1-day ACT workshop in this difficult-to-treat population. After adapting this evidence-based, transdiagnostic treatment [31] [12] for Veterans with this comorbid profile, the pilot RCT study also showed that Veterans in the ACT group, relative to those in the TAU group, showed positive trends towards improvements in in psychiatric symptoms, overall functioning and reintegration. Qualitative data from the pilot phase demonstrated an appreciation for the novelty of this treatment and provided important suggestions for adapting the intervention for Veterans. Suggestions included incorporating a Veteran into the treatment team, greater utilization of military terminology, increased time reviewing manuals and practicing learned skills during session and adjusting workshop timing. Following these adaptations, Veterans from the RCT phase noted general acceptance of the workshop as presented and increased use of skills learned and reported improvements in physical and emotional health. Consistent with core processes in the ACT model of psychological flexibility (e.g., acceptance, attention to the present moment, committed action, and values-based decisions) [32], Veterans at multiple times reported greater focus on increased functionality within the context of physical limitations and elevated stressors. Veterans in both pilot and RCT phases suggested extending the workshop beyond 1 session. It may be that severity of the polytrauma clinical triad may warrant additional treatment time [33] [7]. For example, several Veterans reported cognitive barriers to using the patient manual and workshop skills (e.g., forgetting learned skills after the workshop, misplacing the manual). Thus, repeated presentation and practice of skills and additional memory aids may be particularly important for Veterans experiencing the clinically significant sequelae of the polytrauma clinical triad. Quantitative results among Veterans in the RCT highlighted trends towards greater reduction in psychiatric symptom (DASS-21 and PCLC) for those in the ACT group. Notably, the relative reduction for the ACT group compared to the TAU group in PCLC scores is above the minimum of 5 points that the VA National Center for PTSD recommends in determining a positive response to treatment for PTSD [34]. Furthermore, the ACT group demonstrated greater improvements in functional ability, based on average WHODAS scores. We also evaluated the effect of this treatment on post deployment reintegration difficulties due to the significant challenges faced by Veterans in adjusting to civilian life following deployment [27,35]. Compared to TAU, Veterans in the ACT group exhibited positive trends towards improvements in reintegration. This latter finding is particularly interesting, given that Veterans in this study participated, on average, 8.5 years ( ± 3.0) post deployment, suggesting that the current 1-day treatment helps Veterans address issues of reintegration that have plagued them for years. Given the small sample size of this study, the small-tomedium effect sizes observed for psychiatric symptoms and functioning are noteworthy. Findings are consistent with relevant literature on the efficacy of 1-day, ACT-based workshops for patients with comorbid medical and psychiatric issues [15]. Given that the goal of ACT interventions is to enhance psychological flexibility, it is also noteworthy and promising that positive trends in enhanced psychological flexibility (AAQ) were observed for the ACT but not for the TAU group. Future well-powered studies should examine whether improvements in these processes mediate improvements in distress and functioning. Understanding the mechanisms or processes that mediate clinical improvement in mental health symptoms and functioning allows intervention optimization by refining and emphasizing components responsible for change and eliminating nonactive ingredients [36].
Funding This work was made possible by grant number 1 I21 RX00220901A1 from the Veterans Affairs Rehabilitation Research and Development Service awarded to Lilian N. Dindo and was partially supported by the use and resources of the Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety (CIN13–413). The funding agency did not play a role in study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the 6
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decision to submit the article for publication.The opinions expressed reflect those of the authors and not necessarily those of the Department of Veterans Affairs, the US government or Baylor College of Medicine.
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