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A Randomized Controlled Trial of STARC („Skills Training in Affect Regulation - a Culture-sensitive approach“) in refugees with substance use problems

A Randomized Controlled Trial of STARC („Skills Training in Affect Regulation - a Culture-sensitive approach“) in refugees with substance use problems - PREPARE (Subproject 4)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00017668
Enrollment
286
Registered
2021-08-25
Start date
2020-09-24
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hazardous or harmful substance use (ICD-10 F1X.1) or substance dependence (ICD-10 F1X.2) Symptoms of PTSD, depression or anxiety disorders F10.1 F10.2 F11.1 F11.2 F12.1 F12.2 F13.1 F13.2 F14.1 F14.2 F15.1 F15.2 F16.1 F16.2 F18.1 F18.2 F19.1 F19.2

Interventions

Group 1: STARC-SUD is a culture-sensitive transdiagnostic cognitivebehavioural group therapy for refugees with hazardous substance use or SUD and psychological distress. The intervention consists of 1

Sponsors

Zentrum für Interdisziplinäre Suchtforschung der Universtität Hamburg, Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Psychological distress (GHQ-12 > 13); (2) Hazardous substance or SUD (AUDIT > 7, DUDIT > 6); (3) Exposure to traumatic experiences (e.g., war, persecution, torture, or traumatic experiences during flight; PCL-5); (4) Asylum seeker or refugee with residence status

Exclusion criteria

Exclusion criteria: (1) Acute psychosis; (2) Acute suicidality.

Design outcomes

Primary

MeasureTime frame
Psychological distress at post-treatment and 3-month follow-up measured by General Health Questionnaire - 12 (GHQ-12)

Secondary

MeasureTime frame
at post-treatment and 3-month follow-up: -Emotion dysregulation (Difficulties in Emotion Regulation Scale; DERS) -Substance use severity (Alcohol / Drug] Use Disorder Identification Test; AUDIT / DUDIT); Use in the last 30 days (Addiciton Severity Index; ASI) -Symptoms of posttraumatic stress disorder (PTSD Checklist for DSM-5; PCL-5)

Countries

Germany

Contacts

Public ContactPhilipp Hiller

Zentrum für Interdisziplinäre Suchtforschung (ZIS) der Universität Hamburg, Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf

hiller@zis-hamburg.de040 - 7410 - 57903

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 13, 2026