Böge Kerem, Karnouk Carine, Hoell Andreas, Tschorn Mira, Kamp-Becker Inge, Padberg Frank, Übleis Aline, Hasan Alkomiet, Falkai Peter, Salize Hans-Joachim, Meyer-Lindenberg Andreas, Banaschewski Tobias, Schneider Frank, Habel Ute, Plener Paul, Hahn Eric, Wiechers Maren, Strupf Michael, Jobst Andrea, Millenet Sabina, Hoehne Edgar, Sukale Thorsten, Dinauer Raphael, Schuster Martin, Mehran Nassim, Kaiser Franziska, Bröcheler Stefanie, Lieb Klaus, Heinz Andreas, Rapp Michael, Bajbouj Malek
Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin, Campus Benjamin Franklin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
Lancet Reg Health Eur. 2022 Jun 6;19:100413. doi: 10.1016/j.lanepe.2022.100413. eCollection 2022 Aug.
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).
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.
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 1.30, 95% CI 1.12 to 1.48, p < .001; Cohen's d=.23; baseline-adjusted PHQ-9 mean difference at T 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.
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.
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.
目前的证据表明，难民群体中心理困扰的患病率很高，而资源稀缺，语言、机构、经济和文化障碍又加剧了这一问题。本研究的目的是调查与德国精神卫生保健系统内的常规护理做法（常规治疗，TAU）相比，阶梯式护理与协作模式（SCCM）在减轻难民抑郁症状方面的总体有效性和成本效益。
在德国的七个大学站点进行了一项多中心、临床医生盲法、随机对照试验。庇护寻求者和有相关抑郁症状的难民，患者健康问卷得分≥5分，难民健康筛查得分≥12分。参与者被随机分配到两个治疗组之一（SCCM或TAU），在2018年4月至2020年3月期间进行为期三个月的干预。在SCCM中，参与者被分配到根据其症状严重程度量身定制的干预措施，包括观察等待、同伴或智能手机干预、心理团体治疗或心理健康专家治疗。主要终点定义为12周后抑郁症状的变化（患者健康问卷-9，PHQ-9）。次要结果是从基线到干预后蒙哥马利-Åsberg抑郁评定量表（MADRS）的变化。
意向性分析样本包括584名参与者，他们被随机分配到SCCM组（n = 294）或TAU组（n = 290）。使用具有时间的混合效应一般线性模型，以及以随机分组时间交互作用为固定效应、研究站点为随机效应，我们发现意向性分析和符合方案分析中时间（p < .001）和组间时间交互作用（p < .05）有显著影响。12周后SCCM组PHQ-9评分的估计边际均值显著低于TAU组（意向性分析：T时PHQ-9平均差异为1.30，95%CI为1.12至1.48，p < .001；Cohen's d = .23；基线调整后T时PHQ-9平均差异为0.57，95%CI为0.40至0.74，p < .001）。成本效益和净货币效益分析为主要结果和质量调整生命年提供了成本效益证据。敏感性分析证实了结果的稳健性。
与TAU相比，SCCM在减轻抑郁症状方面更有效且具有成本效益。研究结果表明，在资源有限的情况下，特别是在被迫迁移和大流行的背景下，这是一种提供心理健康服务的合适模式。
本项目由创新基金和德国卫生部资助[资助编号01VSF16061]。本试验已在ClinicalTrials.gov上注册，注册号为：NCT03109028。https://clinicaltrials.gov/ct2/show/NCT03109028 。
