Predictors of outcome of the culturally sensitive group psychotherapy Empowerment for refugees with affective disorders

Theoretical background: Due to various pre-, peri-, and post-displacement stressors that are active in the context of forced migration, refugees are at significant risk of developing mental disorders in the post-migration environment. It is a major challenge for researchers and clinicians to provide effective, culturally sensitive, and accessible mental health interventions to cover the urgent need for psychosocial care in this population. First, this dissertation gives an overview on the existing mental health interventions for refugees and asylum seekers. Second, a systematic overview of available predictor studies in this field is provided. Predictor studies represent a key element in transcultural health care research as they target the question of which refugees benefit from specific treatment options and which ones do not. Data on outcome predictors can be used to allocate refugees to those interventions which they are most likely to benefit from or modify treatment for non-responders, finally providing an empirical foundation to structure the health care system in the most effective and pragmatic possible way. As the number of available predictor studies in the field of refugee treatment is scarce, this dissertation aims to provide a comprehensive predictor analysis of psychotherapeutic treatment for refugees based on a novel group intervention named Empowerment. Methods: This dissertation was conducted within the framework of the multicenter randomized controlled trial MEHIRA (Mental Health in Refugees and Asylum Seekers), investigating a stepped and collaborative care model (SCCM) for refugees with affective disorders. 149 participants who reported moderate depressive symptoms at baseline were allocated to level 3 of the SCCM and randomly assigned either to the Empowerment group therapy or Treatment-as-usual (TAU). Empowerment is a 12-week culturally sensitive group treatment that was developed to equip refugees with functional self-help skills to deal with depressive symptoms and post-migration stressors. Depressive symptoms were assessed at baseline (T0) and post-intervention (T1) using the self-rated Patient Health Questionnaire 9 (PHQ-9) as a primary outcome, and the clinician-rated Montgomery Asberg Depression Rating Scale (MADRS) as a secondary outcome. Predictor analysis was conducted using regression models with change scores (T1-T0) of PHQ-9 and MADRS. Predictors were selected following a mixed-method approach. First, hypothesis-guided hierarchical regression models were calculated with five literature-based predictors. These were baseline depression (PHQ-9, MADRS), post-migration context factors (residence status, employment, housing), and a comorbid PTSD. Second, explorative bivariate regression models were calculated with multiple further baseline variables. Third, final regression models were calculated integrating both findings from hypothesis-guided and explorative models. All analyses were applied both to the Intention-to-treat (ITT) and Per protocol (PP) sample and both to the treatment (Empowerment) and control (TAU) condition. Results: Primary evaluations showed that Empowerment was effective in reducing depressive symptoms (PHQ-9 and MADRS) compared to TAU. Concerning the ITT sample, baseline PHQ-9 (β=-0.35, t=-3.27, p=.002) and baseline self-efficacy (β=-0.24, t=-2.26, p=.027) predicted PHQ-9 change scores, and baseline MADRS (β=-0.71, t=-8.65, p<.001) predicted MADRS change scores, in Empowerment. Concordantly, baseline self-efficacy (β=-0.30, t=-2.41, p=.020) predicted PHQ-9 change scores, and baseline MADRS (β=-0.56, t=-5.50, p<.001) predicted MADRS change scores, in TAU. Thus, analyses were repeated in the pooled ITT sample of both conditions to identify general predictors of refugee treatment outcome. It was found that baseline PHQ-9 (β=-0.30, t=-3.82, p<.001) and baseline self-efficacy (β=-0.29, t=-3.65, p<.001) were predictors of change in PHQ-9, and baseline MADRS (β=-0.71, t=-10.36, p<.001) and housing (β=-0.17, t=-2.51, p=.013) were predictors of change in MADRS. Concerning the PP sample, concomitant psychotherapy (β=0.57, t=3.66, p=.001) and identification as a migrant (β=0.44, t=2.80, p=.010) were predictors of MADRS change scores in Empowerment. In TAU, baseline self-efficacy (β=-0.43, t=-2.89, p=.006) and baseline MADRS (β=-0.34, t=-2.65, p=.012) predicted change in PHQ-9 and MADRS, respectively. Discussion: High rates of baseline depression severity and perceived self-efficacy predicted symptom improvement in participants of both conditions. Although these factors seem to represent global predictors of successful refugee treatment, they may be of high practical relevance in implementing the Empowerment intervention under real-life conditions. Contrary to the hypotheses, post-migration context factors and comorbid PTSD did not predict outcomes in Empowerment. It appears that Empowerment represents a suitable low-threshold intervention to treat a broad and diversified population of refugees in different post-migration stages and settings. A widespread dissemination of the intervention into routine practice may contribute to significant improvements in culturally sensitive mental health care. Ultimately, the presented results may find application in the development of decision-making tools that allow for optimized treatment allocations and ensure a pragmatic health care delivery to refugees in need. To extend the database on relevant outcome predictors, future studies should examine further important socio-cultural variables, such as discrimination and racism, social participation, and strategies of acculturation in the context of culturally sensitive treatment

A house is not a home: a network model perspective on the dynamics between subjective quality of living conditions, social support, and mental health of refugees and asylum seekers

Background: Providing adequate living conditions for forcibly displaced people represents a significant challenge for host countries such as Germany. This study explores refugee mental health’s reciprocal, dynamic relationship with post-migration living conditions and social support. Methods: The study sample included 325 Arabic- or Farsi-speaking asylum seekers and refugees residing in Germany since 2014 and seeking mental health treatment. Associations between reported symptoms of post-traumatic stress and depression and the subjective quality of living conditions and perceived social support were analyzed using a two-level approach including multiple linear regression and network analyses. Results: Post-migration quality of living conditions and perceived social support were significantly associated with negative mental health outcomes on both levels. In the network, both post-migration factors were negatively connected with overlapping symptoms of psychiatric disorders, representing potential target symptoms for psychological treatment. Conclusion: Post-migration quality of living conditions and social support are important factors for refugee mental health and should be targeted by various actors fostering mental well-being and integration

Shared sorrow, shared costs: cost-effectiveness analysis of the Empowerment group therapy approach to treat affective disorders in refugee populations

Background Refugees and asylum seekers (RAS) in Germany need tailored and resource-oriented mental healthcare interventions. Aims To evaluate the cost-effectiveness of group psychotherapy for RAS with moderate depressive symptoms. Method This is a post hoc cost-effectiveness analysis of Empowerment group psychotherapy that was embedded in a stratified stepped and collaborative care model (SCCM) from the multicentre randomised controlled MEHIRA trial. One hundred and forty-nine participants were randomly assigned to SCCM or treatment as usual (TAU) and underwent Empowerment (i.e. level 3 of the SCCM for adults) or TAU. Effects were measured with the nine-item Patient Health Questionnaire (PHQ-9) and quality adjusted life-years (QALY) post-intervention. Health service and intervention costs were measured. Incremental cost-effectiveness ratios (ICER) were estimated and net monetary benefit (NMB) regressions with 95% confidence intervals were performed. Cost-effectiveness was ascertained for different values of willingness to pay (WTP) using cost-effectiveness acceptability curves for probable scenarios. Trial registration number: NCT03109028 on ClinicalTrials.gov. Results Health service use costs were significantly lower for Empowerment than TAU after 1 year. Intervention costs were on average €409.6. Empowerment led to a significant change in PHQ-9 scores but not QALY. Bootstrapped mean ICER indicated cost-effectiveness according to PHQ-9 and varied considerably for QALY in the base case. NMB for a unit reduction in PHQ-9 score at WTP of €0 was €354.3 (€978.5 to −€269.9). Results were confirmed for different scenarios and varying WTP thresholds. Conclusions The Empowerment intervention was cost-effective in refugees with moderate depressive symptoms regarding the clinical outcome and led to a reduction in direct healthcare consumption. Concerning QALYs, there was a lack of confidence that Empowerment differed from TAU

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 T(1) 1.30, 95% CI 1.12 to 1.48, p < .001; Cohen's d=.23; baseline-adjusted PHQ-9 mean difference at T(1) 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/NCT0310902

Empowerment group therapy for refugees with affective disorders: results of a multi-center 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