Patients’ perspectives on treatment with Metacognitive Training for Depression (D-MCT): Results on acceptability

Author’s Accepted Manuscript Patients’ Perspectives on Treatment with Metacognitive Training for Depression (D-MCT): Results on Acceptability Lena Jelinek, Steffen Moritz, Marit Hauschildt www.elsevier.com/locate/jad

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S0165-0327(17)30472-X http://dx.doi.org/10.1016/j.jad.2017.06.003 JAD9002

To appear in: Journal of Affective Disorders Received date: 8 March 2017 Revised date: 22 April 2017 Accepted date: 6 June 2017 Cite this article as: Lena Jelinek, Steffen Moritz and Marit Hauschildt, Patients’ Perspectives on Treatment with Metacognitive Training for Depression (DMCT): Results on Acceptability, Journal of Affective Disorders, http://dx.doi.org/10.1016/j.jad.2017.06.003 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. 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.

Patients’ Perspectives on D-MCT

Jelinek et al.

Patients’ Perspectives on Treatment with Metacognitive Training for Depression (DMCT): Results on Acceptability

Lena Jelinek, Ph.D.,* Steffen Moritz, Ph.D., Marit Hauschildt, Ph.D. University Medical Center Hamburg-Eppendorf Department of Psychiatry and Psychotherapy, Martinistraße 52; 20246 Hamburg, Germany *Correspondence to: University Medical Center Hamburg-Eppendorf; Department of Psychiatry and Psychotherapy, Martinistraße 52, 20246 Hamburg. Tel.: +49 7410 55868; fax: +49 40 7410 57566. [email protected],

Abstract Background Our understanding of how patients perceive and evaluate treatment for depression is scarce. Because dropout rates are high among individuals in treatment for depression, it is necessary to expand the focus of research to patients’ perspectives on the treatment they receive. The aim of the two studies presented was to evaluate patient acceptance of Metacognitive Training for Depression (D-MCT), a highly standardized group intervention. Methods Acceptability was evaluated in an open case series (Study 1, N = 70) and a randomized controlled trial (RCT; Study 2, N = 84). In both studies, participants rated their subjective appraisal on a 15-item questionnaire after administration of eight D-MCT modules. In Study 1, modules were also evaluated individually after each session by a subsample of patients. In Study 2, ratings were compared to an active control intervention (walking and psychoeducation sessions), and assessment was repeated at 6 months follow-up. Results 1

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High rates of acceptance of the D-MCT were demonstrated in both studies immediately after treatment (post-assessment). In addition, the RCT showed better evaluations for the D-MCT than for the control condition at post-assessment as well as at 6 months follow-up. Weekly session evaluations in Study 1 indicated good acceptance for individual modules. Limitations Evaluations could only be obtained from completers; blinding of patients and therapists was not possible. Conclusions Results of the two studies suggest that D-MCT represents a promising group treatment in terms of patient acceptance and provide an example of how patients’ feedback may be used to improve treatment.

Keywords depression, intervention, metacognition, subjective ratings, acceptability

Introduction Research on depression deals with various aspects of the disorder, often focusing on neurobiology and treatment efficacy (van Grieken et al., 2016). However, patients’ perspectives on depression and its treatment have been neglected for a long time (Cuijpers, 2011; Zeng et al., 2016). This is troublesome as the patient’s perspective on the treatment of depression has been found to impact treatment outcomes (Deen et al., 2011; Winter and Barber, 2013). Moreover, one of the main problems with cognitive behavioral therapy (CBT), the most extensively researched evidence-based psychotherapy for depression (Cuijpers, 2015), is its high dropout rate (25–36%, Fernandez et al., 2015; Hans and Hiller, 2013; for psychotherapy in general, see Swift and Greenberg, 2012). These rather high rates indicate that patients’ needs are not being fully met and highlight the importance to include patients’ 2

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views of as well as experiences with treatment. With regard to choice of treatment, studies have reported that patients’ top priority is “effectiveness of the treatment”, followed by “side effects”. In fact, “increased stress related to treatment” was mentioned as one of the potential side effects of most concern from the patient’s but not from the clinician’s, perspective (Barr et al., 2016). When asked about impeding factors in the treatment of depression, patients rate “unavailability of mental healthcare when needed” (i.e., waiting periods) among the four most important themes (van Grieken et al., 2014). Likewise, therapy that is initiated soon after intake may potentially build on hope, which is considered an important factor in treatment success (van Grieken et al., 2016). Fortunately, the patient’s perspective is increasingly being taken into account and is today considered “a central component of current health policy agendas” (Barr et al., 2014), and particular projects are dedicated to patients’ engagement with treatment, such as INVOLVE of the National Institute for Health Research in the United Kingdom and the Patient Centered Outcomes Research Institute (PCORI) in the United States. As such, the patient’s role is evolving to playing an increasingly active role in every step of the research process (Domecq et al., 2014). Insight into patients’ subjective appraisal of their treatment will help us to meet their currently unmet needs and create conditions that treat more patients more effectively. Even if the best treatment currently available were accessible to all patients, however, the burden of depression as indicated by years lived with disability would be reduced by only 30% (Andrews et al., 2004), which further emphasizes that current treatment options may be considered unsatisfactory and that refinement of current treatment is necessary. Generally, the majority of patients diagnosed with depression prefer psychotherapy over pharmacotherapy (van Schaik et al., 2004). However, the percentage of treatment-seeking outpatients receiving psychotherapy has declined to 43%, which is associated with their difficulty accessing psychotherapy (Marcus and Olfson, 2010). To increase access to psychotherapy, 3

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reinforcement of group therapy has recently been promoted by the German Federal Ministry of Health (“Bundesministerium für Gesundheit”, 2017). From a global perspective, it seems of particular importance to develop treatments that are easy to disseminate and that allow task shifting, i.e., treatments that do not need to be delivered by highly trained health care professionals, in order to provide psychotherapy to resource-poor countries (Fairburn and Patel, 2014). To address these problems, we developed the Metacognitive Training for Depression (D-MCT) as a “low-threshold” group treatment of depression following in the tradition of the Metacognitive Training program developed by Steffen Moritz (e.g., Moritz et al., 2014), which was originally developed for patients with psychosis. The low-threshold characteristic of metacognitive training is twofold. First, the threshold is low with regard to administration, as group therapy sessions are highly standardized (using slide and video presentations) and thus easy to administer (appropriate for less experienced clinicians and health practitioners). The group program consists of eight independent modules, and thus patients can join the group at any time in the cycle (there is no waiting time). Second, the threshold is low with regard to participation as patients may, but are not required to, share their individual problems with the group (but are still guided to experience and reflect on how cognitive biases work and influence one’s mood). D-MCT is conceptualized as a variant of CBT that adopts a metacognitive perspective. To the best of our knowledge, D-MCT represents the first manualized intervention that systematically addresses a broad range of depression-related cognitive biases (see Table 1 for all biases included in D-MCT) with a focus on the metacognitive perspective. Although it shares some features with the transdiagnostically oriented Metacognitive Therapy developed by Adrian Wells (Wells, 2011), by targeting dysfunctional metacognitive coping strategies (i.e., thought suppression, rumination), D-MCT works on disorder-specific cognitive biases. In addition, D-MCT is designed to teach participants to recognize and correct their automatic 4

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and unconscious thought patterns that accompany depression and thus, unlike the metacognitive therapy developed by Wells, it also addresses the “content” of depressive thoughts. In addition to depressive thought patterns that are also targeted in classic CBT (e.g., overgeneralization, jumping to conclusions, mind reading), core target domains of D-MCT include a number of general cognitive (information-processing) biases that have been identified by basic cognitive research (e.g., mood-congruent memory, Mathews and MacLeod, 2005; problems in emotion recognition, Douglas and Porter, 2010; Naranjo et al., 2011). Cognitive biases are challenged in D-MCT by the use of creative and engaging exercises and by encouraging patients to take a metacognitive perspective (“to think about thinking”). Preliminary confirmation of the safety and effectiveness of a beta version of the D-MCT was attained in a pilot study involving 104 outpatients with depression (Jelinek et al., 2013). The training reduced depressive symptoms over a treatment period of 8 weeks as indicated by a significant improvement in 56.9% of the patients according to the Reliable Change Index (RCI) at a medium-to-large effect size (Cohen’s d = 0.73). Moreover, cognitive biases and rumination were significantly reduced and self-esteem was increased (effect sizes between d = 0.26 and 0.64). This German paper also makes a passing note of the positive subjective appraisal of D-MCT. To explore the differential efficacy of D-MCT, we performed a parallel RCT comparing two group interventions that were administered as add-ons to an intensive psychosomatic outpatient treatment program: D-MCT (experimental group) versus Health Training (active control group) (Jelinek et al., 2016). Intention-to-treat analyses demonstrated that at the end of treatment (t1), as well as 6 months later (t2), improvement in depression was significantly larger in the D-MCT relative to the active control group, with a medium effect size in self(t1: ηp2 = .049, t2: ηp2 = .114) as well as clinician-assessed depression (t1: ηp2 = .053, t2: ηp2 = 5

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.083). A significantly greater number of patients in the D-MCT group were in remission at the 6-month follow-up (38.7% vs. 13.8%). Finally, the decrease in cognitive biases and increase in psychological well-being/quality of life was larger in the D-MCT than the health training group over time (ηp2 = .037–.115). The aim of the current study was to gain insight into patients’ subjective appraisal of the D-MCT in order to improve the beta version of the training (Study 1) and then evaluate the revised version (Study 2) in order to increase the acceptance of anti-depression treatment and to target the high dropout rates found in patients with depression. In the pilot study (Study 1), feedback was additionally assessed after each module in order to evaluate the content of the individual modules as well as redundancies with other interventions.

Methods Study 1 (Open Case Series) Methods of the open case series are described in more detail elsewhere (Jelinek et al., 2013). One hundred and four outpatients with depression were recruited by the outpatient depression clinic of the Department of Psychiatry and Psychotherapy of the University Medical Center Hamburg-Eppendorf, Germany (59 women and 45 men, mean age of 40.03 years [SD = 10.69], 63.4% graduates of secondary school with a university entrance qualification). Diagnosis relied on assessment by experienced clinicians. Most patients were medicated at baseline assessment (t0, antidepressants n = 51, antipsychotics n = 3, combination n = 14). All patients received D-MCT once a week (90-min group sessions) over a period of 8 weeks and were allowed to receive parallel standard care, including antidepressant medication. Seventy-two patients (69%) completed the post-treatment assessment 8 weeks later (t1). The questionnaire on subjective appraisal was answered by 70 6

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patients (67.3%, per protocol sample). Over a time period of 18 months, all patients were also asked to fill out weekly evaluations immediately after each D-MCT session. Ratings were performed anonymously. Here, the sample size varied between 28 and 44 patients, depending on the D-MCT module (for sample sizes, please see Table 2). Patients received no compensation for participation in the study.

Study 2 (Randomized Controlled Trial) The methods of the RCT are described in more detail elsewhere (Jelinek et al., 2016). Eighty-four patients (62 women and 22 men, mean age of 45.5 years [SD=9.89], mean years of formal education 10.61 [SD = 1.69]) with a depressive disorder treated at a psychosomatic outpatient day clinic (RehaCentrum Hamburg, Klinikum Bad Bramstedt, Hamburg, Germany) were included in the study. Diagnosis of a single episode of major depressive disorder (MDD), recurrent depression, or dysthymia was verified using the Mini International Neuropsychiatric Interview (MINI; Sheehan et al., 1997). Patients were excluded if they were younger than 18 or older than 65 years of age, did not fulfill DSM-IV criteria for unipolar depression, suffered from psychotic symptoms (i.e., hallucinations, delusions, or mania), were currently suicidal (according to the Suicidal Behaviors Questionnaire-Revised, SBQ-R, Osman, 2002, total score > 6), showed signs of intellectual disability (estimated IQ < 70), or could not be assessed due to distress. Patients were not excluded on the basis of comorbid psychiatric disorders with the exception of the aforementioned diagnoses. Pharmacotherapy was tolerated. At baseline, 36 patients (43%) were diagnosed with a single episode of MDD, 47 (56%) with recurrent depression, and one with dysthymia (1%). At intake, more than half of the patients (n = 43) met criteria for at least one comorbid disorder according to the MINI 7

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(comorbid disorders: anxiety disorders n = 38, substance use disorder n = 4, and eating disorder n = 1). Mean illness duration was 96 months (M = 95.63, SD = 104.96). On average, patients had experienced a total of three depressive episodes (M = 3.03, SD = 5.69) and were hospitalized for the second time (M = 1.68, SD = 1.13). All patients received an intensive psychosomatic outpatient treatment program 5 days a week for 8 hours a day and were randomized to one of the following add-on interventions: DMCT (experimental group) or Health Training (HT, active control group). Randomization was performed after baseline assessment according to a fixed computer-generated randomization plan with a 1:1 allocation ratio. D-MCT was delivered twice a week (60-min group sessions) over a period of 4 weeks and was based on a published manual (Jelinek et al., 2015; for English material, see www.uke.de/depression). HT was equivalent regarding frequency and duration of sessions and group format. It was comprised of weekly group walking sessions (60 min) and weekly psychoeducation sessions on various health topics (60 min; e.g., stress reduction, nutrition, and weight loss). Patients were assessed by raters blind to treatment allocation at baseline (t0) as well as 4 weeks (post-treatment, t1) and 6 months later (followup, t2). Patients were reimbursed for their expenses to attend the follow-up assessment (€30). Completion rate at t1 was 94.0% and at t2 was 71.4% (see Jelinek et al., 2016). The questionnaire on subjective appraisal of the treatment was answered by 41 patients of the HT (95.3%) and 36 patients of the D-MCT (87.8%) at post-treatment (t1) and by 29 (67.4%) and 31 (75.6%) patients, respectively, at the follow-up assessment (t2, per protocol sample).

Measures Acceptability

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A subjective appraisal rating scale was constructed. The questionnaire consisted of 15 questions regarding acceptance of the interventions that were answered using a 5-point Likert scale (1 = completely agree and 5 = completely disagree; see Figures 1 and 2 for items). Moreover, in two open questions patients were asked to state what they liked and disliked about the training in their own words. This questionnaire was presented at the end of treatment (Study 1: after 8 weeks; Study 2: after 4 weeks, along with an evaluation of the HT) and, for the RCT, additionally at follow-up 6 months after treatment. In Study 1, subjective appraisal was also assessed after each session, but only over a time period of 18 months, thus data was only available for a subsample. Items were largely similar for both studies (see Table 2).

Data Analyses For the RCT, Student’s t tests were calculated in order to compare groups (D-MCT/HT).

Results Study 1 (Open Case Series) On average, patients with available data from baseline and post-treatment assessment (complete case sample, CC) attended seven of the eight D-MCT modules (M = 6.60, SD = 1.47). In non-completers (n = 32, 31%), 12 (37.5%) attended more than half of the possible eight D-MCT sessions and none dropped out after one session. The number of D-MCT sessions attended by dropouts were: two sessions n = 11; three sessions n = 5, four sessions n = 4, five sessions n = 2, six sessions n = 2, seven sessions n = 5, eight sessions n = 3. Four patients informed the study therapists about their reason to drop out from the intervention:

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three patients dropped out because they started inpatient treatment and one patient was no longer able to provide childcare during session. Analyses were carried out for the CC sample, which comprised N = 70 (38 women and 32 men, mean age of 41.13 years [SD = 9.90], mean years of formal education 11.81 years [SD = 1.56]), and did not differ significantly from non-completers. As can be seen in Figures 1 and 2, D-MCT was positively evaluated by the majority of the patients. All patients evaluated the training as “useful and sensible” (100% endorsement of “I completely agree” or “I agree”) and affirmed that the rationale of the treatment was clear to them. Moreover, 82% stated that they had transferred the lessons learned to everyday life, 97% indicated that the training was fun, and 94% said they would recommend the training to others. Eighty-five percent stated that the training improved their understanding of the disorder. Only 14% indicated that they had to force themselves to attend the training. In the free text fields, patients lauded the structure of the training (“open group”, “images in the presentation”, “presentation of the information”), and the atmosphere (“fun”, “dealing in a humorous way with a heavy topic”) as well as groupspecific factors (“exchange with other patients”). However, especially for the more severely depressed patients, the amount of information addressed within one module was often too large, as indicated by answers to open questions. The results related to the acceptability of each individual D-MCT module are displayed in Table 2. Patients generally evaluated individual modules positively.

Study 2 (RCT) In Study 2, data for 77 participants with a depressive disorder (58 women and 19 men, mean age of 45.90 years [SD = 9.72], mean years of formal education of 10.60 [SD = 1.71]) were available at the post-treatment assessment (t1). The completers did not differ significantly 10

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from the non-completers. On average, patients in the D-MCT group attended seven of the eight D-MCT sessions (M = 6.71, SD = 2.08). As can be seen in Figures 1 and 2, subjective appraisal of the D-MCT at the post-treatment assessment was positive in the RCT; 83% judged the D-MCT to be “useful and sensible”, 78% indicated that they would “apply the lessons learned in everyday life”, 80% judged the training as “fun”, and 85.4% “would recommend D-MCT to others”. In response to the two open-ended questions, patients stated, for instance, that the examples used in the training were “easy to understand” and “taken from real life”. They also liked the group format (“hearing what other participants say”, “I feel less alone”), “handouts and material”, “transfer to daily life”, and found that “the recurrent theme was easy to follow”. Suggestions for improvement predominantly concerned the time slot of the group sessions (“too late in the day”) and the need for a more detailed introduction of the homework assignment. In comparison to HT, D-MCT received better evaluations at posttreatment assessment on all items (see Table 3). Superior evaluation of the D-MCT was also found at the 6-month follow-up. Six months after the training was completed, patients still assessed D-MCT as superior with regard to usefulness, positive effects on other treatment, fun, long-term benefits, understanding of the disorder, and improvement in coping with depression. However, at the follow-up assessment patients rated both interventions similarly low on two items — “The training had negative effects on other interventions” and “My disorder became worse due to the training”—and participants in the D-MCT disagreed more with the item “My thinking is more confused” compared to participants in the control intervention on trend level.

Discussion The aim of the present study was to investigate patients’ perspectives on the D-MCT, a highly standardized CBT-based depression-specific group treatment that has been shown to be 11

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effective in an open case series and a RCT. In summary, acceptability of D-MCT was high in both the open case series (Study 1) as well as in the RCT (Study 2). In both studies, the majority of the patients would recommend D-MCT to others (85.4–94%), and the majority assessed the training as “useful and sensible” (83–100%) and affirmed its transfer to their daily lives (78–82%). Finally, D-MCT received better evaluations than the control treatment (HT) on all items at t1 (and the majority of items at t2) in the RCT. Dropout during treatment, representing another index for acceptability, differed between the two studies. Despite positive therapy appraisal in both studies by the completers, the dropout rate during treatment was much lower in Study 2 (6%) than in Study 1 (31%), and thus requires explanation. First, in Study 1 we used a preliminary version of the D-MCT, which we revised for Study 2. In addition, in Study 1 we reassessed patients after 8 weeks and in Study 2 already after 4 weeks. Moreover, differences between the two studies in both available resources for data collection and treatment settings may be responsible for the discrepancy in dropout. Regarding data collection, “dropout during treatment” refers to the patients that did not complete post-treatment assessment. This does not necessarily mean patients terminated D-MCT prematurely. Indeed, 12 patients (37.5% of the dropouts) attended more than half of the possible D-MCT sessions and none dropped out after one session in Study 1. While we did not systematically note reasons for dropout in Study 1, reasons for uncollected post-treatment assessment may have been a result of a lack of resources (pilot study was not externally funded, i.e. patients did not receive reimbursement for assessments) and questionnaires had to be filled out at home and sent back by patients after treatment had terminated. Moreover, differences in treatment settings even more likely explain the discrepancy. In Study 1, we recruited patients seeking treatment at an outpatient depression clinic, which offers treatment contacts on a weekly to monthly basis, corresponding to a common outpatient sample. Consequently, the sample may have been more heterogeneous 12

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with regard to patients' individual treatment needs and agenda. For example, several of the participants who received D-MCT were additionally enrolled on waitlist for inpatient treatment or individual psychotherapy and may therefore have dropped out prematurely when they were offered the treatment slot they applied for (as indicated by three patients as reason for dropout). Yet others may have benefited sufficiently from only few D-MCT sessions and therefore terminated treatment before the end of 8 weeks. In Study 2, however, all patients were engaged in an intense and rather binding treatment plan (5 days a week, for 8h/day), and while patients were accommodated at home, treatment resembled a common inpatient program. As indicated by the meta-analysis by Fernandez and colleagues (2015), dropout is generally higher in outpatient treatment than in inpatient treatment and may potentially explain higher dropout in Study 1. In the course of refining treatment, we need to have a better understanding of patients’ perspectives on our interventions in order to reduce the dropout rate and be able to treat more patients with depression more effectively. Therefore, it is of special interest that the majority (80–97%) of the patients in our trials affirmed that they had fun during D-MCT. “Fun” is deemed an important component in the treatment of depression because the condition is characterized by poor motivation and a low level of joy. This potential aspect of intervention has, so far, primarily been stressed in the therapeutic use of video games (e.g., Russoniello et al., 2013). To the best of our knowledge, however, D-MCT represents the only approach in which entertainment and engagement are explicit factors. Moreover, our results confirmed that the large majority of patients did not have to force themselves to attend sessions (as was also indicated by attendance rates). In view of the disorder-inherent low motivation, attendance is a particular challenge in the treatment of depression. D-MCT, with its unique features, seems to address this problem successfully. In the targeting of depression-specific cognitive biases, patients are generally taught that “to err is human”. As it has been suggested 13

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that depression is associated with an abnormal response to negative feedback (Elliott et al., 1997, 1996) and performance deterioration in post-error trials (Compton et al., 2008; Steffens et al., 2001), it may be particularly important for patients to experience cognitive errors/“mistakes” in a positive, playful, and “fun” atmosphere.

Long-Term Subjective Appraisal In the RCT, subjective ratings of D-MCT were repeated 6 months after the post-treatment assessment to explore the patients’ long-term appraisal of the training. Positive ratings and, in fact, superiority in comparison to HT were maintained for the majority of the items, indicating that patients’ positive evaluations of D-MCT are reliable and long lasting. However, these results need to be replicated independently, and comparison to additional group interventions would be desirable.

Implications for Application of D-MCT D-MCT may generally be considered a low-intensity program, with group CBT located in the middle between low- and high-intensity interventions, according to the National Institute for Health and Clinical Excellence (2009). Moreover, requirements for participation in D-MCT are lower than in standard CBT groups (e.g., D-MCT has an open group format, inferences are made from demonstrations and examples, and personal problems do not need to be shared). Therefore, D-MCT may be used to bridge the time gap between diagnosis of depression and high-intensity intervention (such as individual CBT), which may not always be immediately available. At this point, we believe that particularly strong points of the administration of D-MCT are that its low-intensity, seminar-like setting and entertaining nature may reduce the prejudice, skepticism, and stigma associated with psychotherapy by 14

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many patients and potentially increase their treatment motivation. Participants in our trials evaluated the group setting and sharing of experiences with their fellow patients as positive factors in feeling understood, reducing self-stigmatization as well as shame. This may be specifically promoted by the entertaining approach of the D-MCT, which alternates fun and serious elements and structured reports of individual problems, in contrast to problem-focused groups in which extensive listening and dealing with the problems of others may be overwhelming for some patients. Instead, D-MCT provides a positive self-experience in the group while at the same time respect and compassion for the seriousness of the disorder are conveyed. Finally, in addition to potential individual benefits, group CBT programs are considered more cost- and time-effective than individual CBT (Tucker and Oei, 2007).

Revision Based on Feedback Although patients’ perspectives on the complete D-MCT program were the main focus of the two studies, individual modules were additionally assessed in Study 1 in order to revise contents based on the participants’ feedback. Favorable evaluations were also found on the individual module level, especially with regard to fun, personal relevance, and use in everyday life. Patients’ feedback on the general as well as individual level was used to revise the beta version of the training for the RCT (e.g., sessions were shortened from 90 to 60 min, examples were modified), and thus, in combination, the two studies provide an example of how patients’ feedback may be integrated in the evaluation and improvement of treatments. This ongoing, elaborate process is necessary to refine the training. Although it is difficult to collect strong evidence for the efficacy of a treatment if parts of the treatment are changed during the evaluation process, refinement is necessary in order to improve the patients’ outcome, which should always be the ultimate goal.

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Limitations Although the study has a number of strengths (e.g., two studies, a large number of participants, evaluation of individual modules, use of an active control intervention in the RCT), limitations also need to be addressed. First and most importantly, the present results have to be interpreted in view of researcher allegiances (Munder et al., 2013). As the study was conducted by the developer of D-MCT (LJ, SM, MH) and members of their working group, a biasing effect is likely, so replication studies by other research groups would be highly desirable. Secondly, other biasing effects need to be mentioned, particularly the lack of therapist and patient blinding in the RCT that may affect the outcome if patients learn that they are not receiving the experimental treatment (Mohr et al., 2009). However, the credibility of the treatment rationale and of the positive outcome expectations was explained to the therapists as well as to the patients in the control group. “Walking” (which was part of the health training) is considered an active anti-depressive intervention (for a recent meta-analysis on effects of exercise on depression, see Schuch et al., 2016), and the health training groups were conducted by experienced, competent, and dedicated personnel, ensuring effective delivery with the required allegiance (the control group may not be considered a placebo group). Thirdly, evaluations were only obtained from completers and may thus be biased. However, the completion rate of 94% from t0 to t1 was rather high for the RCT, and at 69% it was still acceptable for the open case series.

Conclusion Based on the results of the two studies, D-MCT represents a promising group treatment in terms of patient acceptance. Our results showed that important attributes of the D-MCT (e.g., 16

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fun, engaging, positive atmosphere) were positively reflected by patients’ subjective feedback. Several additional distinct features (e.g., one topic per module, open-group format) seem to make it especially feasible for the treatment of depression. Efficacy studies of antidepression interventions should include an assessment of patients’ perspectives as a standard measure in order to make treatment more patient-centered and trustworthy.

Contributors LJ, SM, and MH designed the study and wrote the protocol. LJ analyzed the data and wrote the first draft of the manuscript. LJ, SM, and MH edited the manuscript. All authors read and approved the final manuscript.

Financial Support The RCT was funded by a grant from “Verein zur Förderung der Rehabilitationsforschung in Hamburg, Mecklenburg-Vorpommern und Schleswig-Holstein (vffr)” (www.reha-vffr.de); grant #161. The vffr had no role in the design and conduct of the study; collection, management, analysis, or interpretation of the data; preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication.

Conflicts of Interest Metacognitive Training for Depression (D-MCT) was developed by the authors (LJ, SM, and MH).

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Acknowledgements We would like to thank Dr. Ruth Veckenstedt, Francesca Bohn, Natalia Steiner, Martina Fieker, Irmgard Musyal, Mirja Schwarz, Mario Broccucci, and Dr. Gabriela Kuhn for their help with recruitment of participants for the RCT and Prof. Christian Otte for his help in recruiting patients for the open case series.

Table 1 D-MCT Modules and Content Module Name

Content (Cognitive Bias)

1

Thinking and Reasoning 1

Mental filter, overgeneralization

2

Memory

Mood-congruent memory, false memories

3

Thinking and Reasoning 2

“Should” statements, disqualifying the positive, black-and-

4

Self-Worth

Perfectionism, self-worth

5

Thinking and Reasoning 3

Magnification and minimization, attributional style

6

Behaviors and Strategies

Dysfunctional coping strategies: withdrawal, ruminating, thought suppression

7

Thinking and Reasoning 4

Jumping to conclusions: mind reading, fortune telling

8

Perception

Identification of emotions, emotional reasoning

white thinking

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of Feelings

19

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Table 2 Subjective Appraisal of D-MCT Modules (Study 1): Percent Endorsement “I Completely Agree” (1) and “I Agree” (2) Module

Item

N

1

2

3

4

5

6

7

8

33

28

30

31

35

41

33

44

·

The session was fun.

90.9

96.4

96.7

96.8

85.7

92.7

97

90.9

·

I learned something new.

97

89.3

90

90.3

80.0

75.6

87.5a

86.4

·

The content of today’s

90.6a

92.9

89.3b

90.0c

91.4

97.4d

87.9

86e

100a

92.9

90

93.5

97.1

100f

90.9

95.3e

81.3a

82.1

86.2g

74.2

82.4h

77.5f

84.8

72.7

96.9a

92.9

89.7g

87.1

91.4

90f

100

76.7e

8i

9.1j

22.7j

20.8k

13.8g

21.9a

3.4g

17.1l

session was personally relevant to me. ·

I will apply the lessons learned in today’s session in everyday life.

·

Today’s session will help me to cope better with depression.

·

Today’s session will help me to appraise situations in a less one-sided/negative way.

·

The content of today’s session overlapped with the content of other therapies (e.g., CBT depression group, interpersonal skill training).

a j

N = 32; b N = 28; c N = 30; d N = 39; e N = 43; f N = 40; g N = 29; h N = 34; i N = 25; j N = 22;

N = 25; k N = 24; l N = 35

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Jelinek et al.

2.33 (1.15)

3.45 (1.15)

t(74) = 4.23,

t(64.40) = 3.08,

The training had positive

4.32 (0.91)

p = .003

4.83 (0.51)d

p < .001

effects on other interventions.

The training had negative

part of my treatment program.

2.92 (1.24)

t(64.39) = 5.88,

1.53 (0.77)

t(64.98) = 3.94,

The training was an important

2.88 (1.22) e

p < .001

p < .001

1.97 (0.74)

3.56 (1.30)

my everyday life.

I apply the lessons learned in

the training regularly.

4.56 (0.84)

t(69.21) = 4.02,

t(65.01) = 5.43,

I had to force myself to attend

2.59 (1.20)

Statistics

p < .001

1.39 (0.69)

The training was useful and

(n = 41)

sensible.

(n = 36)

Item

2.43 (1.22) c

4.57 (0.97) c

1.90 (1.04)

2.23 (0.50)

4.39 (0.80)

1.45 (0.62)

(n = 31)

D-MCT

D-MCT

HT

Follow-up (t2)

Post-treatment (t1)

Table 3. Subjective Appraisal of D-MCT and HT in the Randomized Controlled Trail: Mean (SD)

Patients’ Perspectives on D-MCT

3.55 (1.21)

4.70 (0.67) b

2.90 (1.26)

3.14 (1.19)

3.76 (1.30)

2.72 (1.10)

(n = 29)

HT

t(57) = 3.53,

p = .542

t(55) = 0.61,

p = .002

t(58) = 3.33,

p = .030

t(37.02) = 3.84,

p = .030

t(46.09) = 2.24,

p < .001

t(43.73) = 5.56,

Statistics

21

understanding of the disorder.

p < .001

t(73.46) = 5.12,

3.12 (1.31)

The training has improved my

1.78 (0.99)

p < .001

the training in the long run.

t(74) = 4.45,

2.78 (1.10)

I am certain I will benefit from

t(55.10) = 3.83, p < .001

4.02 (1.21)

to the training. 1.80 (0.75)

4.82 (0.51)

My disorder became worse due

p = .003

t(75) = 3.11,

4.61 (0.93)

My thinking is more confused.

3.90 (1.07)

p < .001

training to others.

t(62.61) = 5.53,

2.51 (1.19)

I would recommend the

1.33 (0.63)

p < .001

t(57.91) = 4.26,

training were clear to me.

2.00 (1.05)

1.22 (0.48)

The goals and rationale of the

p < .001

t(65.06) = 4.86,

1.47 (0.65)

The training was fun.

2.49 (1.14)

p < .001

effects on other interventions.

Patients’ Perspectives on D-MCT

1.69 (0.60)

1.93 (0.96)

4.52 (0.72)

4.53 (0.82) c

1.37 (0.61) c

1.35 (0.66)

1.71 (0.97)

Jelinek et al.

3.14 (1.40) a

3.10 (1.29)

4.31 (0.89)

4.14 (1.03)

2.66 (1.31)

2.00 (1.13)

2.41 (1.09)

p <.001

t(35.71) = 5.11,

p <.001

t(51.69) = 3.95,

p =.332

t(54.06) = 0.98,

p = .107

t(53.53) = 1.63,

p < .011

t(39.36) = 4.79,

p = .011

t(44.43) = 2.67,

p = .010

t(58) = 2.65,

p = .001

22

2.03 (0.94)

3.42 (1.14) p < .001

t(74.73) = 5.85,

2.00 (0.77)

Jelinek et al.

a

n = 28. b n = 27, c n = 30, d n = 35; e n = 40.

Note. Ratings were made on a 5-point Likert scale (1 = completely agree and 5 = completely disagree).

disorder has improved.

My ability to cope with the

Patients’ Perspectives on D-MCT 2.90 (1.05) p < .001

t(58) = 3.79,

23

Jelinek et al.

OCS

RCT

OCS

RCT

OCS

RCT

OCS

RCT

OCS

RCT

completely agree

RCT

OCS

RCT

OCS

RCT

OCS agree

My ability to cope with the disorder has improved

The training improved my understanding of the disorder

I am certain I will benefit from the training in the long run

OCS

I would recommend the training to others RCT

The goals and rationale of the training were clear

The training was fun

The training had positive effects on other interventions

The training was an important part of my treatment

OCS

I apply the lessons learned in my everyday life RCT

The training was useful and sensible

0%

20%

30%

neither agree nor disagree

10%

40%

disagree

50%

60%

80%

90%

completely disagree

70%

100%

24

Figure 1: Subjective Appraisal of D-MCT in the Randomized Controlled Trail (RCT, N = 36) and Open Case Series (OCS, N = 70) – Positive Items

Patients’ Perspectives on D-MCT

Jelinek et al.

25

Figure 2: Subjective Appraisal of D-MCT in the Randomized Controlled Trail (RCT, N = 36) and Open Case Series (OCS, N = 70) – Inverse Items

Patients’ Perspectives on D-MCT

Patients’ Perspectives on D-MCT

Jelinek et al.

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Highlights - Patient acceptance of the D-MCT was high - Patients’ positive evaluations of D-MCT were reliable and long lasting - Attributes of the D-MCT (e.g., fun) were positively reflected by patients’ feedback - Individual modules were evaluated positively - Patient’s views may be used to improve interventions and reduce dropout

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