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New approach tackles social stressors to help refugees with PTSD

NCT ID NCT04244864

Symptom relief Sponsor: Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding a social support program to standard therapy helps trauma-affected refugees with PTSD. 196 unemployed refugees received either standard treatment or standard treatment plus collaboration with municipal social services. The goal was to improve daily functioning and reduce mental health symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cross-sectoral psychosocial intervention
What this could lead to
If successful, this approach could improve daily functioning and mental health for trauma-affected refugees by addressing social stressors alongside therapy.
What could go wrong
This is a completed trial with 196 participants, but results may not apply to all refugee populations. Adding social collaboration may not significantly improve outcomes over standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

196 people

The number who actually took part.

Started

Feb 2020

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder post-traumatic stress disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression Post-traumatic stress disorder Psychosocial problem

Contacts and locations

Locations

  • Competence Centre for Transcultural Psychiatry

    Ballerup Municipality, Capital Region, 2750, Denmark

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