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Open Access 01-12-2022 | Study protocol

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

Authors: Ingo Schäfer, Philipp Hiller, Sascha Milin, Annett Lotzin

Published in: Trials | Issue 1/2022

Abstract

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

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Title: 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
Authors: Ingo Schäfer
Philipp Hiller
Sascha Milin
Annett Lotzin
Publication date: 01-12-2022
Publisher: BioMed Central
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06761-4

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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