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

Abstract

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://ichgcp.net/clinical-trials-registry/NCT03109028.

Keywords: Asylum seekers; Cost-effectiveness; Depression; Germany; Interventions; Mental health care; Refugees; SCCM; Stepped-care and collaborative model.

Conflict of interest statement

Dr. Banaschewski served in an advisory or consultancy role for Lundbeck, Medice, Neurim Pharmaceuticals, Oberberg GmbH, Takeda, and Infectopharm. He received conference support or speaker's fee from Lilly, Medice, and Takeda. He received royalties from Hogrefe, Kohlhammer, CIP Medien, Oxford University Press; the present work is unrelated to these relationships. Alkomiet Hasan has been invited to scientific meetings by Lundbeck, Janssen, and Pfizer, and he received paid speakerships from Desitin, Janssen, Otsuka, and Lundbeck. He was a member of Roche, Otsuka, Lundbeck, and Janssen advisory boards. Paul Plener was involved in clinical trials of Lundbeck and Servier. He received a speaker's honorarium from Shire and Infectopharm. Frank Padberg is a member of the European Scientific Advisory Board of Brainsway Inc., Jerusalem, Israel, and has received speaker's honoraria from Mag&More GmbH and the neuroCare Group. His lab has received support with equipment from neuroConn GmbH, Ilmenau, Germany, and Mag&More GmbH and Brainsway Inc., Jerusalem, Israel. The other authors declare no competing interests.

© 2022 The Author(s).

Figures

Figure 1

Intervention pyramid of the Stepped Care and Collaborative Model (SCCM) for adults (upper part) and adolescents (lower part of figure)

Figure 2

Flow chart of recruitment and randomization allocation

Figure 3

Scores on the PHQ-9 (primary outcome) and the MADRS scale (secondary outcome) as a function of randomization group (TAU vs. SCCM) and time (T0 vs. T1) for the ITT sample. Note. Error bars represent 95% confidence intervals.

Figure 4

Net-Monetary Benefit - cost-effectiveness acceptability curves for all scenarios of SCCM vs TAU on PHQ. Note. Probability that SCCM intervention is acceptable (values on the vertical axis) in relation to TAU on the willingness to pay for a reduction of PHQ values by one point, given varying thresholds for willingness to pay (horizontal axis) based on 10,000 bootstrapped ICER replications. The small dotted line (0.95 – probability) indicates the upper 95%CI, i.e. the maximum amount that has to be invested to be confident that SCCM is cost-effective. Intersections of CEAC with the confidence line represents cost-effectiveness for a specific scenario. Thus, these λ were €171 for Base Case, €52 for Optimal Case, and €375 for On-top Case (representing cost of intervention only), respectively. SCCM=Stepped and Collaborative Care, TAU=Treatment as Usual, PHQ=Patient Health Questionnaire, CEAC=Cost-Effectiveness Acceptability Curve.

Figure 5

Net-Monetary Benefit - cost-effectiveness acceptability curves for all scenarios of SCCM vs TAU concerning QALY. Note. Probability that SCCM intervention is acceptable (values on the vertical axis) in relation to TAU on the willingness to pay for an additional quality adjusted life year, given varying thresholds for willingness to pay (horizontal axis) based on 10,000 bootstrapped ICER replications. The small dotted line (0.95 – probability) indicates the upper 95%CI, i.e. the maximum amount that has to be invested to be confident that SCCM is cost-effective. Intersections of CEAC with the confidence line represents cost-effectiveness for a specific scenario.These λ were €11,874 and €20,000 for Base Case, and €1,100 and €30,000 for Optimal Case. CEAC for the On-top Case (representing cost of intervention only) asymptotically approximates the upper 95%CI, the higher the chosen WTP, but did not intersect the confidence line. SCCM=Stepped and Collaborative Care, TAU=Treatment as Usual, QALY=Quality Adjusted Life Years, CEAC=Cost-Effectiveness Acceptability Curve.