Cross-sectoral Collaboration in Multidisciplinary Treatment of Trauma-affected Refugees

NCT04244864 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2026-01-15

No results posted yet for this study

Summary

INTRODUCTION Trauma-affected refugees are at high risk of developing mental health problems including post-traumatic stress disorder (PTSD) and depression. In addition to traumatic stress, refugees are furthermore subject to a range of post-migration stressors e.g. unemployment, poor finances and language difficulties. These stressors can moderate or exacerbate mental health outcomes in refugees.

Cross-sectoral collaboration and coordination of municipal social interventions and regional mental health services are currently limited.

The overall aim of this study is to investigate the effect of a psychosocial treatment with a focus on social stressors in an integrated cross-sectoral collaboration with the municipality for trauma-affected refugees

MATERIALS AND METHODS The study is being conducted at Competence Centre for Transcultural Psychiatry (CTP) in Denmark. Included in the study are refugees with post-traumatic stress disorder (PTSD), who are unemployed and attending a municipal job centre in one of the five collaborating municipalities. Approximately 200 patients will be included. The randomised controlled trial is comparing treatment as usual (TAU) comprising 10 sessions with a medical doctor (pharmacological treatment and psycho-education) and 16-21 sessions with a psychologist (manual-based cognitive behavioural therapy) with add-on of the social intervention. Overall, the intervention seeks to integrate working with social stressors alongside treatment for trauma-related mental health problems. This is done in two ways; by a cross-sectoral collaboration with municipality through collaborative meetings and by a systematic focus on social stressors during the treatment.

The primary outcome is functioning, measured by WHODAS 2.0 12 item version together with a variety of secondary outcomes measuring mental health symptoms, quality of life and degree of social stressors.

RESULTS The study is expected to bring forward new perspectives and knowledge on psychosocial treatment of trauma-affected refugees as well as cross-sectoral collaboration.

Conditions

  • Post Traumatic Stress Disorder
  • Depression
  • Psychosocial Problem

Interventions

BEHAVIORAL

Cross-sectoral psychosocial intervention

The intervention seeks to integrate working with social stressors alongside treatment for trauma-related mental health problems. This is done in two ways; by a cross-sectoral collaboration with the patient's case counsellor in the municipality including three collaborative meetings and by a systematic focus on social stressors during the treatment.

BEHAVIORAL

Treatment as usual (TAU)

Medical doctor, 10 sessions: Pharmacological treatment according to standard algorithm and psychoeducation. Psychologist 16-21 sessions: Manual-based cognitive behavioural therapy.

Sponsors & Collaborators

  • Copenhagen Municipality, Denmark

    collaborator OTHER_GOV
  • Municipality of Lyngby-Taarbæk, Denmark

    collaborator UNKNOWN
  • Gladsaxe Municipality, Denmark

    collaborator OTHER
  • Frederikssund Municipality, Denmark

    collaborator UNKNOWN
  • Hillerød Municipality, Denmark

    collaborator UNKNOWN
  • Mental Health Services in the Capital Region, Denmark

    lead OTHER

Principal Investigators

  • Maja Bruhn · Mental Health Services in the Capital Region, Denmark

  • Jessica Carlsson · Mental Health Services in the Capital Region, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-03
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04244864 on ClinicalTrials.gov