A multicenter, randomized controlled trial to compare the effectiveness of STARC-SUD (Skills Training in Affect Regulation - a Culture-sensitive approach) versus treatment as usual in trauma-exposed refugees with substance use problems

BACKGROUND: Refugees often report high levels of psychological distress due to traumatic experiences before and during flight as well as many post-migration stressors. Refugees with hazardous substance use or existing substance use disorder (SUD) are a particularly vulnerable group for whom few preventive and therapeutic measures are available. The aim of this study is to investigate the effectiveness of an integrative culturally sensitive group therapy approach (STARC-SUD) to improve affect regulation in refugees with substance-related problems.

METHODS: The study aims to include N = 286 male refugees with psychological distress (GHQ-12 > 13) and hazardous substance use or SUD (AUDIT > 7 or DUDIT > 6). Therapists working supported by interpreters will deliver the STARC-SUD intervention in addiction aid facilities in six metropolitan regions of Germany. The primary endpoint is severity of psychological distress (GHQ-12). The effectiveness of STARC-SUD is compared with treatment as usual (TAU) post-intervention and 3 months later.

DISCUSSION: This trial will be one of the first RCTs on a culturally sensitive transdiagnostic intervention for trauma-exposed refugees with hazardous substances or SUD. The trial might gain new insights into the efficacy of such an intervention.

TRIAL REGISTRATION: OSF Registry osf.io/nhxd4 . Registered prospectively on September 22, 2020, doi: 10.17605/OSF.IO/NHXD4. DRKS DRKS00017668.