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

NCT04244864 | Completed

• 1 other identifier: PTF6
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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

Depression; Post Traumatic Stress Disorder; Psychosocial Problem

Keywords

Post Traumatic Stress Disorder; Refugees; Cross-sectoral collaboration; Treatment

Outcome Measures

Primary Outcomes (1)

• The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), interviewer administered 12-item version

  Measure of health and disability across cultures. Scoring range: 0-48, lower scores reflect better outcome.

  Change from baseline to end-of-treatment after approximately 10 months

Secondary Outcomes (9)

• The Harvard Trauma Questionnaire (HTQ) Part IV

  Change from baseline to end-of-treatment after approximately 10 months

• Hopkins Symptom Check List - 25 (HSCL-25)

  Change from baseline to end-of-treatment after approximately 10 months

• World Health Organisation - 5 Well-being Index (WHO-5)

  Change from baseline to end-of-treatment after approximately 10 months

• European Quality of Life (EQ-5D-5L)

  Change from baseline to end-of-treatment after approximately 10 months

• Sheehan Disability Scale (SDS)

  Change from baseline to end-of-treatment after approximately 10 months

Study Arms (2)

Treatment as usual (TAU)

ACTIVE COMPARATOR

8-12 months of treatment

Behavioral: Treatment as usual (TAU)

Cross-sectoral social intervention

EXPERIMENTAL

8-12 months of treatment

Behavioral: Cross-sectoral psychosocial intervention; Behavioral: Treatment as usual (TAU)

Interventions

Treatment as usual (TAU) BEHAVIORAL

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

Cross-sectoral social intervention; Treatment as usual (TAU)

Cross-sectoral psychosocial intervention BEHAVIORAL

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.

Cross-sectoral social intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 years or older).
• Refugees or persons who have been family reunified with a refugee.
• PTSD pursuant to the ICD-10 research criteria.
• Psychological trauma experienced outside Denmark in the anamnesis. Trauma is imprisonment or detention with torture (according to the United Nations' definition of torture) or acts of cruel, inhuman and degrading treatment or punishment. Trauma can also be organised violence, long-term political persecution and harassment, or war and civil war experiences.
• Home address in one of the five collaborating municipalities.
• Unemployed and assigned to a jobcentre in a collaborating municipality.
• Signed informed consent.

You may not qualify if:

• Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F31.9). Participants are excluded only if the psychotic experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and/or depression.
• Dependence syndrome of drugs or alcohol: Active dependence and use (F1x.24-F1x.26).

Sponsors & Collaborators

• Copenhagen Municipality, Denmark: collaborator
• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• Municipality of Lyngby-Taarbæk, Denmark: collaborator
• Gladsaxe Municipality, Denmark: collaborator
• Frederikssund Municipality, Denmark: collaborator
• Hillerød Municipality, Denmark: collaborator

Study Sites (1)

Competence Centre for Transcultural Psychiatry

Ballerup Municipality, Capital Region, 2750, Denmark

Location

Related Publications (1)

• Bruhn M, Laugesen H, Kromann-Larsen M, Trevino CS, Eplov L, Hjorthoj C, Carlsson J. The effect of an integrated care intervention of multidisciplinary mental health treatment and employment services for trauma-affected refugees: study protocol for a randomised controlled trial. Trials. 2022 Oct 8;23(1):859. doi: 10.1186/s13063-022-06774-z.

  PMID: 36209104 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Maja Bruhn

  Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

• Jessica Carlsson

  Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: January 18, 2020
• First Posted: January 28, 2020
• Study Start: February 3, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)