Empowerment group therapy for refugees with affective disorders: results of a multicenter randomized controlled trial.

BACKGROUND: Against the background of missing culturally sensitive mental health care services for refugees, we developed a group intervention (Empowerment) for refugees at level 3 within the stratified Stepped and Collaborative Care Model of the project Mental Health in Refugees and Asylum Seekers (MEHIRA). We aim to evaluate the effectiveness of the Empowerment group intervention with its focus on psychoeducation, stress management, and emotion regulation strategies in a culturally sensitive context for refugees with affective disorders compared to treatment-as-usual (TAU). METHOD: At level 3 of the MEHIRA project, 149 refugees and asylum seekers with clinically relevant depressive symptoms were randomized to the Empowerment group intervention or TAU. Treatment comprised 16 therapy sessions conducted over 12 weeks. Effects were measured with the Patient Health Questionnaire-9 (PHQ-9) and the Montgomery-Åsberg Depression Rating Scale (MÅDRS). Further scales included assessed emotional distress, self-efficacy, resilience, and quality of life. RESULTS: Intention-to-treat analyses show significant cross-level interactions on both self-rated depressive symptoms (PHQ-9; F(1,147) = 13.32, p < 0.001) and clinician-rated depressive symptoms (MÅDRS; F(1,147) = 6.91, p = 0.01), indicating an improvement in depressive symptoms from baseline to post-intervention in the treatment group compared to the control group. The effect sizes for both scales were moderate (d = 0.68, 95% CI 0.21-1.15 for PHQ-9 and d = 0.51, 95% CI 0.04-0.99 for MÅDRS). CONCLUSION: In the MEHIRA project comparing an SCCM approach versus TAU, the Empowerment group intervention at level 3 showed effectiveness for refugees with moderately severe depressive symptoms.

Predicting treatment outcomes of the Empowerment group intervention for refugees with affective disorders: Findings from the MEHIRA project.

BACKGROUND: Research on outcome predictors in the field of transcultural treatment for refugees and asylum seekers (RAS) is scarce. We aimed to evaluate predictors of outcome of a group intervention (Empowerment) for RAS with affective disorders which was incorporated at level three of the stratified stepped-care model within the Mental Health in Refugees and Asylum Seekers (MEHIRA) project. METHODS: A predictor analysis was performed at level three of the MEHIRA project, where 149 refugees with moderate depressive symptoms were treated either with Empowerment or Treatment-as-usual (TAU). Outcome measures were depression severity as assessed by patient-rated Patient Health Questionnaire 9 (PHQ-9) and clinician-rated Montgomery Asberg Depression Rating Scale (MADRS). Regression models with change scores (T1-T0) of PHQ-9 and MADRS as dependent variables were fit. Predictor selection was a mixed-method approach combining testing of literature-based hypotheses and explorative hypothesis-generating analyses of multiple baseline variables. RESULTS: Intention-to-treat (ITT) analyses revealed significant linear relationships between change in PHQ-9 and baseline depression severity (ß = -0.35, t = -3.27, p = .002) and perceived self-efficacy (ß = -0.24, t = -2.26, p = .027) in the treatment (verum) condition. MADRS change scores were predicted by baseline depression severity (ß = -0.71, t = -8.65, p < .001) in the treatment (verum) condition. LIMITATIONS: Due to small cell numbers, single predictors could not be evaluated reliably. CONCLUSIONS: Severity of depression and self-efficacy at baseline were predictors of symptom improvement at level three (Empowerment) of the MEHIRA project. Comorbidity and trauma indicators did not predict outcomes in the treatment (verum) condition, pointing towards broad applicability of the Empowerment intervention in refugee populations.

Effectiveness and cost-effectiveness for the treatment of depressive symptoms in refugees and asylum seekers: A multi-centred randomized controlled trial.

Background: Current evidence points towards a high prevalence of psychological distress in refugee populations, contrasting with a scarcity of resources and amplified by linguistic, institutional, financial, and cultural barriers. The objective of the study is to investigate the overall effectiveness and cost-effectiveness of a Stepped Care and Collaborative Model (SCCM) at reducing depressive symptoms in refugees, compared with the overall routine care practices within Germany's mental healthcare system (treatment-as-usual, TAU). Methods: A multicentre, clinician-blinded, randomised, controlled trial was conducted across seven university sites in Germany. Asylum seekers and refugees with relevant depressive symptoms with a Patient Health Questionnaires score of ≥ 5 and a Refugee Health Screener score of ≥ 12. Participants were randomly allocated to one of two treatment arms (SCCM or TAU) for an intervention period of three months between April 2018 and March 2020. In the SCCM, participants were allocated to interventions tailored to their symptom severity, including watchful waiting, peer-to-peer- or smartphone intervention, psychological group therapies or mental health expert treatment. The primary endpoint was defined as the change in depressive symptoms (Patient Health Questionnaire-9, PHQ-9) after 12 weeks. The secondary outcome was the change in Montgomery Åsberg Depression Rating Scale (MADRS) from baseline to post-intervention. Findings: The intention-to-treat sample included 584 participants who were randomized to the SCCM (n= 294) or TAU (n=290). Using a mixed-effects general linear model with time, and the interaction of time by randomisation group as fixed effects and study site as random effect, we found significant effects for time (p < .001) and time by group interaction (p < .05) for intention-to-treat and per-protocol analysis. Estimated marginal means of the PHQ-9 scores after 12 weeks were significantly lower in SCCM than in TAU (for intention-to-treat: PHQ-9 mean difference at T1 1.30, 95% CI 1.12 to 1.48, p < .001; Cohen's d=.23; baseline-adjusted PHQ-9 mean difference at T1 0.57, 95% CI 0.40 to 0.74, p < .001). Cost-effectiveness and net monetary benefit analyses provided evidence of cost-effectiveness for the primary outcome and quality-adjusted life years. Robustness of results were confirmed by sensitivity analyses. Interpretation: The SSCM resulted in a more effective and cost-effective reduction of depressive symptoms compared with TAU. Findings suggest a suitable model to provide mental health services in circumstances where resources are limited, particularly in the context of forced migration and pandemics. Funding: This project is funded by the Innovationsfond and German Ministry of Health [grant number 01VSF16061]. The present trial is registered under Clinical-Trials.gov under the registration number: NCT03109028. https://clinicaltrials.gov/ct2/show/NCT03109028.