Differential Psychological Treatment Effects in Patients With Late-Life Depression and a History of Childhood Maltreatment.

OBJECTIVE: This is the first interventional study to assess the impact of childhood maltreatment (CM) on psychological treatment outcomes in patients with late-life depression (LLD). METHODS: This is a secondary analysis of a multicenter, randomized controlled trial with 251 participants aged ≥60 years with moderate to severe depression. Participants were randomly assigned to cognitive behavioral therapy for late life depression (LLD-CBT) or to a supportive intervention (SUI). Treatment outcomes were measured by changes in the Geriatric Depression Scale (GDS). RESULTS: In the intention-to-treat sample (n = 229), both LLD-CBT (n = 115) and SUI (n = 114) significantly reduced depressive symptoms in patients with CM, with large effects at post-treatment (d = 0.95 [95% CI: 0.65 to 1.25] in LLD-CBT; d = 0.82 [95% CI: 0.52 to 1.12] in SUI). A significant treatment group*CM interaction (F(1,201.31) = 4.71; p = .031) indicated greater depressive symptom reduction in LLD-CBT compared to SUI at week 5 and post-treatment for patients without CM, but not at 6-month follow-up. Across both treatments, higher severity of the CM subtype 'physical neglect' was associated with a smaller depressive symptom reduction (F(1,207.16) = 5.37; p = .021). CONCLUSIONS: Specific and non-specific psychotherapy effectively reduced depressive symptoms in older individuals with depression and early trauma. For patients without early trauma, LLD-CBT may be preferable over SUI. Considering early trauma subtypes may contribute to develop personalized treatment approaches.

Longitudinal Clusters of Long-Term Trajectories in Patients with Early-Onset Chronic Depression: 2 Years of Naturalistic Follow-Up after Extensive Psychological Treatment.

INTRODUCTION: In clinical trials, mostly group-level treatment effects of repeated cross-sectional measures are analyzed. However, substantial heterogeneity regarding individual symptom profiles and the variability of treatment effects are often neglected, especially over the long-term course. To provide effective personalized treatments, investigations of these characteristics are urgently needed. METHODS: Depression severity ratings over 104 weeks of follow-up after year-long treatment with the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or Supportive Psychotherapy (SP) were analyzed. Longitudinal cluster analysis and multinomial logistic regression analysis were conducted to investigate intraindividual trajectories from one of the largest psychotherapy trials in early-onset chronic depression. RESULTS: Two-year post-study-treatment trajectories of N = 188 patients with early-onset chronic depression were grouped into four prototypical clusters. Overall, 16.0% of patients remitted (cluster 1) and most of them did not receive any treatment during the 2-year follow-up. However, 84.0% of patients continued to experience subthreshold (37.2% cluster 2) or major depressive symptoms (46.8% clusters 3-4) and spent on average more than half of the follow-up in pharmacological and psychological treatment. Hierarchical regression analysis indicated that previous study treatment with CBASP or SP did not significantly predict cluster allocation, while baseline variables accounted for a large proportion of explained variance (R2 N = 0.64). CONCLUSION: While some patients experienced stable remission over 2 years of follow-up, the majority of patients experienced subthreshold or major depressive symptoms regardless of former study treatment with CBASP or SP. This calls for a long-term perspective implementing staging and innovative treatment approaches such as the sequential model or modular psychotherapy.

Oxytocin-Augmented Modular-Based Group Intervention for Loneliness: A Proof-Of-Concept Randomized Controlled Trial.

INTRODUCTION: Loneliness poses a significant health problem and existing psychological interventions have shown only limited positive effects on loneliness. Based on preliminary evidence for impaired oxytocin signaling in trait-like loneliness, the current proof-of-concept study used a randomized, double-blind, placebo-controlled design to probe intranasal oxytocin (OT) as an adjunct to a short-term modular-based group intervention for individuals suffering from high trait-like loneliness (HL, UCLA Loneliness Scale ≥55). METHODS: Seventy-eight healthy HL adults (56 women) received five weekly group psychotherapy sessions. HL participants received OT or placebo before the intervention sessions. Primary outcomes were trait-like loneliness measured at baseline, after the intervention, and again at two follow-up time points (3 weeks and 3 months), and, assessed at each session, state loneliness (visual analog scale), perceived stress (Perceived Stress Scale, PSS-10), quality of life (World Health Organization Five Well-Being Index, WHO-5), and the therapeutic relationship (Group Questionnaire, GQ-D). RESULTS: The psychological intervention was associated with significantly reduced perceived stress and improved trait-like loneliness across treatment groups, which was still evident at the 3-month follow-up. OT had no significant effect on trait-like loneliness, quality of life, or perceived stress. However, compared to placebo, OT significantly facilitated the decrease in state loneliness within sessions and significantly improved positive bonding between the group members. CONCLUSION: Despite significantly improved trait-like loneliness after the intervention, OT did not significantly augment this effect. Further studies are needed to determine optimal intervention designs to translate the observed acute effects of OT into long-term benefits.

Identifying subgroups with differential response to CBASP versus Escitalopram during the first eight weeks of treatment in outpatients with persistent depressive disorder.

There exists little empirical evidence helping clinicians to select the most effective treatment for individual patients with persistent depressive disorder (PDD). This study identifies and characterizes subgroups of patients with PDD who are likely to benefit more from an acute treatment with psychotherapy than from pharmacotherapy and vice versa. Non-medicated outpatients with PDD were randomized to eight weeks of acute treatment with the Cognitive Behavioral Analysis System of Psychotherapy (CBASP; n = 29) or escitalopram plus clinical management (ESC/CM; n = 31). We combined several baseline variables to one composite moderator and identified two subgroups of patients: for 56.0%, ESC/CM was associated with a greater reduction in depression severity than CBASP, for the remaining 44.0%, it was the other way around. Patients likely to benefit more from ESC/CM were more often female, had higher rates of moderate-to-severe childhood trauma, more adverse life events and more previous suicide attempts. Patients likely to benefit more from CBASP were older, had more often an early illness onset and more previous treatments with antidepressants. Symptomatic response, remission, and reductions in symptom severity occurred more often in those patients treated with their likely more effective treatment condition. The findings suggest that the baseline phenotype of patients with PDD moderates their benefit from acute treatment with CBASP relative to ESC/CM. Once confirmed in an independent sample, these results could serve to guide the choice between primarily psychotherapeutic or pharmacological treatments for outpatients with PDD.

Symptom-specific improvement across therapies and their putative mediators: A mediation network intervention analysis.

OBJECTIVE: We evaluated differential treatment effects on specific symptoms and their mediators for Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and Supportive Psychotherapy (SP) in persistently depressed patients. METHOD: We conducted a Bayesian mediation network intervention analysis with data from a randomized controlled trial comparing CBASP and SP. Three networks were calculated to investigate (1) differential treatment effects on specific symptoms, (2) differential treatment effects on the potential mediators interpersonal problems and social functioning, and (3) associations between change in symptoms and change in the potential mediators. RESULTS: First, we found no evidence that CBASP more strongly improves most depressive symptoms specifically, except minimal evidence of symptom-specific effects on sleeping problems and self-esteem. Second, no and minimal evidence for differential treatment effects on interpersonal problems and social functioning was shown, respectively. Third, interpersonal problems and social functioning were strongly related to depressive symptoms. CONCLUSION: While CBASP showed superior treatment effects for overall symptom severity, this treatment might not be superior in improving specific symptoms and the potential mediators interpersonal problems and social functioning. Still, interpersonal problems and social functioning seem to play an important role for depression symptoms. Future research needs to further investigate potential working mechanisms of CBASP.Trial registration: ClinicalTrials.gov identifier: NCT00970437.

Cognitive Behavioral Therapy for Late-Life Depression (CBTlate): Results of a Multicenter, Randomized, Observer-Blinded, Controlled Trial.

INTRODUCTION: Different psychotherapeutic interventions for late-life depression (LLD) have been proposed, but their evaluation in large, multicenter trials is rare. OBJECTIVE: The present study evaluated the efficacy of a specific cognitive behavioral therapy (CBT) for LLD (LLD-CBT) in comparison with a supportive unspecific intervention (SUI), both administered in a specialist psychiatric outpatient setting. METHODS: In this randomized, controlled, parallel group trial, we recruited participants (≥60 years) with moderate to severe depression at 7 trial sites in Germany. Participants were randomly assigned to the LLD-CBT or SUI group. The primary outcome was depression severity at the end of treatment measured by change on the Geriatric Depression Scale (GDS). Secondary outcomes included change in observer-rated depression, anxiety, sleep ratings, and quality of life throughout the treatment phase and at 6-month follow-up. RESULTS: Between October 1, 2018, and November 11, 2020, we randomly assigned 251 patients to either LLD-CBT (n = 126) or SUI (n = 125), of whom 229 provided primary-outcome data. There was no significant between-group difference in the change in GDS scores at the end of treatment (estimated marginal mean difference: -1.01 [95% CI: -2.88 to 0.86]; p = 0.287). Secondary analyses showed significant improvements in several outcomes after 8 weeks and at follow-up in both treatment arms. CONCLUSIONS: Our data suggest that LLD-specific CBT and a supportive unspecific treatment both provide clinical benefit in patients with moderate to severe LLD without evidence for superiority of LLD-CBT.

["IThink it's Good that they Choose who they want to be Stroked by" -The Support Quality of Animal-BasedTherapy]. / "Ich finde es gut, dass sie sich aussuchen, von wem sie gestreichelt werden wollen" ­ Die Unterstützungsqualität tiergestützter Therapie.

For Adolescents with personality impairments it's often difficult to accept therapy offers. Personality impairment may be preceded by (early childhood) trauma, which undermines trust in others.Thus, adolescents with traumatic experience often have limited motivation to start psychotherapy, also due to the greater need for autonomy and the process of detachment in this age phase. However, adolescence is a particularly sensitive period, as personality impairments may consolidate and personality disorders (PD) develop. To address low trust and lowmotivation in adolescents with high risk for or already full PD an animal-assisted group therapy adjunct to individual mentalization-based therapy was developed and piloted. Two groups with a total of eleven patients each were conducted, four of whom agreed to talk about their experiences with animal-assisted therapy in an interview after completion of therapy. Interviews were analyzed qualitatively and evaluated with regard to the aspects of what the adolescents liked and disliked, what expectationsweremet or unmet, andwhat effects the adjunct intervention had on the adolescents' therapeutic success.The categorized statements are discussed related to the theories of human-animal interaction according to Hediger et al. (2019) and a new hypothesis about animals as teambuilding catalysts could be established. In sum, alpacas were perceived suitable as therapy animals for adolescents with personality impairments.

An online program with individualized vs automated support for significant others of depressed individuals - study protocol of a randomized controlled trial.

BACKGROUND: Due to budget restrictions in mental health care, non-professional caregivers are increasingly burdened with the emotional and practical care for their depressed relatives. However, informal family caregiving is mostly a stressful role with negative consequences on the physical and mental health of the caretakers to the extent that they have an elevated risk of experiencing psychiatric disorders themselves. While psychoeducation for relatives of depressed individuals showed positive results both in terms of the caretakers' strain and the depressive symptoms of the affected person, there are major barriers to participate in presence in those programs. Digital programs might be a viable alternative. We found no empirically evaluated digital program available for informal caregivers of depressed patients. METHODS: An online program for relatives of depressed individuals has been developed including four interactive modules on 1) psychoeducation, 2) how to strengthen the relationship with the depressed person, 3) how to deal with the depressive symptoms of the patient, and 4) find the right balance between caring for the depressed person and self-care. We investigate if this self-help program is more effective when used with individualized versus automated e-mail support, and if both supported conditions are more effective than treatment-as-usual (TAU in form of written information material) in terms of the risk of mental diseases in caregivers. The primary outcome is the reduction of the caregiver's nonspecific mental distress as measured by the change of the Kessler Psychological Distress Scale score from baseline to four weeks after randomization. Caregivers (n = 500:500:250) will be randomized to one of the three conditions. DISCUSSION: Psychological support for caregivers of individuals with mental disorders such as depression should be offered as part of integrated services. There is a huge potential to develop and implement interactive online approaches to support informal caregivers of patients with depression to function in their multiple roles and to help them to remain healthy. TRIAL REGISTRATION: DRKS, DRKS00025241 . Registered 5 Mai 2021.

Effects of alliance ruptures and repairs on outcomes.

This study explored whether treatment outcomes in a trial on the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) vs. Supportive Psychotherapy (SP) for patients with early-onset chronic depression differ between alliance patterns.Session-to-session ratings of the therapeutic alliance (Helping Alliance Questionnaire (HAQ)) from 254 outpatients with chronic depression (CBASP: 134; SP: 120) who took part in a multicenter randomized controlled trial of CBASP vs. SP were used to categorize patients into three alliance pattern categories for the patients' and therapists' rating separately. Based on the reliable change in the HAQ from one session to the next categories were: no rupture, unrepaired rupture, rupture-repair. Depression severity (24-item Hamilton Rating Scale for Depression) at post-treatment, at 12- and 24- months follow-up was the outcome.The alliance pattern categories for therapists and patients did not differ between CBASP and SP. Only the alliance patterns calculated for patients were associated with outcome: in the unrepaired rupture category, patients had higher HRSD-ratings across time points (p = 0.047).CBASP was not associated with more or fewer ruptures or repairs as compared to SP in the treatment of chronic depression. The study highlights the need to resolve ruptures to avoid poor outcomes.Trial registration: ClinicalTrials.gov identifier: NCT00970437.

Interactive impact of childhood maltreatment, depression, and age on cortical brain structure: mega-analytic findings from a large multi-site cohort.

BACKGROUND: Childhood maltreatment (CM) plays an important role in the development of major depressive disorder (MDD). The aim of this study was to examine whether CM severity and type are associated with MDD-related brain alterations, and how they interact with sex and age. METHODS: Within the ENIGMA-MDD network, severity and subtypes of CM using the Childhood Trauma Questionnaire were assessed and structural magnetic resonance imaging data from patients with MDD and healthy controls were analyzed in a mega-analysis comprising a total of 3872 participants aged between 13 and 89 years. Cortical thickness and surface area were extracted at each site using FreeSurfer. RESULTS: CM severity was associated with reduced cortical thickness in the banks of the superior temporal sulcus and supramarginal gyrus as well as with reduced surface area of the middle temporal lobe. Participants reporting both childhood neglect and abuse had a lower cortical thickness in the inferior parietal lobe, middle temporal lobe, and precuneus compared to participants not exposed to CM. In males only, regardless of diagnosis, CM severity was associated with higher cortical thickness of the rostral anterior cingulate cortex. Finally, a significant interaction between CM and age in predicting thickness was seen across several prefrontal, temporal, and temporo-parietal regions. CONCLUSIONS: Severity and type of CM may impact cortical thickness and surface area. Importantly, CM may influence age-dependent brain maturation, particularly in regions related to the default mode network, perception, and theory of mind.

Cognitive behavioural therapy for insomnia does not appear to have a substantial impact on early markers of cardiovascular disease: A preliminary randomized controlled trial.

According to the World Health Organization, cardiovascular diseases are the leading cause of death in the world. Therefore, early prevention of these diseases is a public health priority. Epidemiological data suggest that insomnia may be a modifiable risk factor for cardiovascular diseases. A randomized controlled trial in a sample of insomnia patients without cardiovascular disease was conducted to investigate the effects of insomnia treatment on early markers of cardiovascular diseases assessed by 24-hr ambulatory blood pressure, heart rate and heart rate variability monitoring, and morning fasting blood samples. Forty-six patients with insomnia disorder were randomized to cognitive behavioural therapy for insomnia (CBT-I; n = 23) or a waitlist control condition (n = 23). Contrary to the hypothesis, intention-to-treat analyses did not show any significant treatment effects on early markers of cardiovascular disease (d = 0.0-0.6) despite successful insomnia treatment (d = 1.3). Potential methodological and conceptual reasons for these negative findings are discussed. Future studies might include larger sample sizes that are at risk of cardiovascular diseases and focus on other cardiovascular markers.

Patients' interpersonal problems as moderators of depression outcomes in a randomized controlled trial comparing mindfulness-based cognitive therapy and a group version of the cognitive-behavioral analysis system of psychotherapy in chronic depression.

OBJECTIVES: Interpersonal problems were examined as moderators of depression outcomes between mindfulness-based cognitive therapy (MBCT) and cognitive behavioral analysis system of psychotherapy (CBASP) in patients with chronic depression. METHODS: Patients received treatment-as-usual and, in addition, were randomized to 8-weeks of MBCT (n = 34) or 8-weeks of CBASP (n = 34). MBCT and CBASP were given in a group format. The Hamilton depression rating scale (HAM-D) was the primary and the Beck Depression Inventory (BDI-II) the secondary outcome. The subscales of the Inventory of interpersonal problems (IIP-32) were moderators. Multilevel models were performed. RESULTS: Higher scores on the "vindictive/self-centered" subscale were associated with a better outcome in MBCT than in CBASP (HAM-D: p < .01; BDI-II: p < .01). Higher scores on the "nonassertive" subscale were associated with a better outcome in CBASP than in MBCT (HAM-D: p < .01; BDI-II: p < .01). CONCLUSIONS: If these results can be replicated in larger trials, MBCT should be preferred to CBASP in chronically depressed patients being vindictive/self-centered, whereas CBASP should be preferred to MBCT in chronically depressed patients being nonassertive.

Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression.

OBJECTIVES: A recent trial comparing Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and supportive psychotherapy in chronic depression found CBASP to be more effective in treating depressive symptoms. We aimed to evaluate adverse events that occurred during this trial. MATERIALS AND METHOD: A randomized trial of chronically depressed outpatients was performed. The treatment included 32 sessions of CBASP or supportive psychotherapy. Therapists asked patients about adverse events and their intensity in each session using a standardized checklist. We analyzed the mean number of (severe) adverse events per patient up to Session 32 with gamma frailty recurrent event models. RESULTS: Two hundred and sixty patients were included in the analyses (66% female, mean age 45 years). Patients in the supportive psychotherapy group reported less severe adverse events in general, and less severe adverse events related to personal life and to occupational life than patients in the CBASP group. Less adverse events related to suicidal thoughts were reported in the CBASP compared with the supportive psychotherapy group. CONCLUSIONS: Differences in the adverse events profile may be explained by the treatment elements. Adverse events related to personal and occupational life for example might be considered a necessary and expected yet temporary adverse treatment outcome of an effective CBASP treatment.

Do interpersonal fears mediate the association between childhood maltreatment and interpersonal skills deficits? A matched cross-sectional analysis.

Objective: Childhood maltreatment, interpersonal fear and a specific kind of interpersonal skills deficit (preoperational thinking) have all been associated with persistent depressive disorder (PDD). We hypothesize that interpersonal fears mediate the association between childhood maltreatment and preoperational thinking.Method: A total of 108 matched participants have been examined cross-sectionally (31 healthy controls, 30 patients with episodic depression and 47 patients with PDD) with the following instruments: the Childhood Trauma Questionnaire (CTQ-SF), a measure of interpersonal fear (CBASP Interpersonal Questionnaire) and the Lübeck Questionnaire of Preoperational Thinking.Results: Patients with PDD reported significantly more childhood maltreatment than patients with episodic depression (d = 0.65) and healthy controls (d = 1.29). They also had more interpersonal fears (d = 0.71 and d = 2.11 respectively) and higher levels of preoperational thinking (d = 0.90 and d = 2.78 respectively). The association between childhood maltreatment and preoperational thinking was mediated through interpersonal fears.Conclusions: Our findings might have important implications for psychotherapy of PDD because they demonstrate how specific problems in social interactions can be associated with interpersonal fears that arise secondary to childhood maltreatment.

[Anxiety and Depression in Transition - Desiderata for Improved Care and Research: Results of the Joint Task Force Transition of DGPPN and DGKJP]. / Angst und Depression in der Transition ­ Desiderate für eine verbesserte Versorgung und Forschung: Ergebnisse der gemeinsamen Task-Force Transition von DGPPN und DGKJP.

Anxiety and Depression in Transition - Desiderata for Improved Care and Research: Results of the Joint Task Force Transition of DGPPN and DGKJP Abstract. Affective disorders (e. g., anxiety, depression) frequently begin during adolescence. Yet therapeutic approaches during adolescence differ in some respects from those employed during adulthood. During the transition from adolescence to adulthood, there is a high risk of discontinuation of therapeutic treatment, which may consequently affect integration in employment. There is a need for age-specific therapeutic strategies that address the relevant issues of adolescents as well as the presently unmet needs in research and treatment for this specific population.

Two-Year Follow-Up after Treatment with the Cognitive Behavioral Analysis System of Psychotherapy versus Supportive Psychotherapy for Early-Onset Chronic Depression.

BACKGROUND: Evidence on the long-term efficacy of psychotherapeutic approaches for chronic depression is scarce. OBJECTIVE: To evaluate the effects of the Cognitive Behavioral Analysis System of Psychotherapy (CBASP) compared to Supportive Psychotherapy (SP) 1 year and 2 years after treatment termination. METHODS: In this study, we present 1- and 2-year follow-up assessments of a prospective, multicenter, evaluator-blinded, randomized clinical trial of outpatients with early-onset chronic major depression (n = 268). The initial treatment included 32 sessions of CBASP or SP over 48 weeks. The primary outcome was the rate of "well weeks" (Longitudinal Interval Follow-Up Evaluation; no/minimal symptoms) after 1 year and 2 years. The secondary outcomes were, among others, clinician- and self-rated depressive symptoms, response/remission rates, and quality of life. RESULTS: Of the 268 randomized patients, 207 (77%) participated in the follow-up. In the intention-to-treat analysis, there was no statistically significant difference between CBASP and SP patients in experiencing well weeks (CBASP: mean [SD] of 48.6 [36.9] weeks; SP: 39.0 [34.8]; rate ratio 1.26, 95% CI 0.99-1.59, p = 0.057, d = 0.18) and in remission rates (CBASP: 1 year 40%, 2 years 40.2%; SP: 1 year 28.9%, 2 years 33%) in the 2 years after treatment. Statistically significant effects were found in favor of CBASP 1 year after treatment termination regarding the rate of well weeks, self-rated depressive symptoms, and depression-related quality of life. CONCLUSIONS: CBASP lost its superiority over SP at some point between the first and the second year. This suggests the necessity of maintenance treatment for early-onset chronically depressed patients remitted with CBASP during the acute therapy phase, as well as the sequential integration of other treatment strategies, including medication for those who did not reach remission.

Cognitive behavioural therapy for the treatment of late life depression: study protocol of a multicentre, randomized, observer-blinded, controlled trial (CBTlate).

BACKGROUND: Late-life depression (LLD) is one of the most prevalent mental disorders in old age. It is associated with various adverse outcomes and frequent use of health care services thereby remaining a serious public health concern. Compared with depression in early adulthood, most treatment options of LLD are less effective. Psychotherapy may be particularly beneficial for LLD due to specific psychological conditions in old age and a low risk of side effects. Although cognitive behavioural therapy (CBT) is highly established and effective in depression in young and mid-life there is only a limited number of small studies on CBT in LLD. An LLD-specific CBT has not yet been compared to an active, but unspecific supportive psychological intervention in a multicentre trial. METHODS: Here we present the design of the CBTlate trial, which is a multicentre, randomized, observer-blinded, active-controlled, parallel group trial. CBTlate aims at including 248 patients with LLD of both genders at 7 sites in Germany. The purpose of the study is to test the hypothesis that a 15-session individually-delivered CBT specific for LLD is of superior efficacy in reducing symptoms of depression in comparison with a supportive unspecific intervention (SUI) of the same quantity. The intervention includes 8 weeks of individual treatment sessions twice per week and a follow-up period of 6 months after randomization. The primary end point is the severity of depression at the end of treatment measured by the self-rated 30-item Geriatric Depression Scale (GDS). Secondary endpoints include depressive symptoms at week 5 and at follow-up (6 months after randomization). Additional secondary endpoints include the change of depressive symptoms assessed with a clinician-rating-scale and a patient reported outcome instrument for major depressive disorder, anxiety symptoms, sleep, cognition, quality of life, and overall health status from baseline to end-of treatment and to end of follow-up. Add-on protocols include MRI and the collection of blood samples. DISCUSSION: This study is the first multicentre trial of a specific CBT intervention for LLD compared to an unspecific supportive psychological intervention administered in a specialist setting. It has important implications for developing and implementing efficient psychotherapeutic strategies for LLD and may be a significant step to broaden treatment options for people suffering from LLD. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03735576, registered on 24 October 2018); DRKS (DRKS00013769, registered on 28 June 2018).

Cognitive-Behavioral Analysis System of Psychotherapy, Drug, or Their Combination for Persistent Depressive Disorder: Personalizing the Treatment Choice Using Individual Participant Data Network Metaregression.

BACKGROUND: Persistent depressive disorder is prevalent, disabling, and often difficult to treat. The cognitive-behavioral analysis system of psychotherapy (CBASP) is the only psychotherapy specifically developed for its treatment. However, we do not know which of CBASP, antidepressant pharmacotherapy, or their combination is the most efficacious and for which types of patients. This study aims to present personalized prediction models to facilitate shared decision-making in treatment choices to match patients' characteristics and preferences based on individual participant data network metaregression. METHODS: We conducted a comprehensive search for randomized controlled trials comparing any two of CBASP, pharmacotherapy, or their combination and sought individual participant data from identified trials. The primary outcomes were reduction in depressive symptom severity for efficacy and dropouts due to any reason for treatment acceptability. RESULTS: All 3 identified studies (1,036 participants) were included in the present analyses. On average, the combination therapy showed significant superiority over both monotherapies in terms of efficacy and acceptability, while the latter 2 treatments showed essentially similar results. Baseline depression, anxiety, prior pharmacotherapy, age, and depression subtypes moderated their relative efficacy, which indicated that for certain subgroups of patients either drug therapy or CBASP alone was a recommendable treatment option that is less costly, may have fewer adverse effects and match an individual patient's preferences. An interactive web app (https://kokoro.med.kyoto-u.ac.jp/CBASP/prediction/) shows the predicted disease course for all possible combinations of patient characteristics. CONCLUSIONS: Individual participant data network metaregression enables treatment recommendations based on individual patient characteristics.