Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Improving PTSD treatment through patient engagement strategies

Official title: Patient Engagement in PTSD Treatment (PEP) - Advancing PTSD Treatment Outcomes

Run by Herlev and Gentofte Hospital · NCT06755710 · Data updated 2026-11-12

This study is testing if adding extra support like motivation sessions and shared decision-making can help people with PTSD stick with their treatment and feel better compared to standard care.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment427 (estimated)
SponsorHerlev and Gentofte Hospital
Academic / other
Locations1 site (Ballerup Municipality, Capital Region)
StatusRecruiting
StartedJanuary 2, 2025
Main results expectedFebruary 29, 2028
Study endsAugust 31, 2028
Registry record updatedJuly 14, 2026
Trial IDNCT06755710 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older diagnosed with PTSD according to ICD-10 criteria, particularly refugees or individuals with a history of trauma.

Probably not a fit

Patients with severe psychotic disorders or active substance dependence may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study aims to enhance the effectiveness of outpatient PTSD treatment by implementing two randomized controlled trials at clinics serving ethnic Danes and refugees. The study investigates whether adding a motivation enhancement module and a Shared Decision-Making session can reduce dropout rates and improve treatment outcomes compared to standard treatment. Participants will be randomized into different treatment arms, including a control group receiving treatment as usual and intervention groups receiving additional support. The focus is on understanding how these enhancements can lead to better engagement and outcomes for patients with PTSD.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment retention and outcomes for patients suffering from PTSD.

How similar studies have gone: Previous studies have indicated that enhancing motivation and employing shared decision-making can positively impact treatment outcomes, suggesting a promising approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
In- and exclusion criteria of the randomised controlled trial for Psychotherapeutic Unit

Inclusion Criteria:

* Adults (18 years or older)
* PTSD pursuant to the ICD-10 research criteria
* Signed informed consent
* patients referred to "Main Level" treatment

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).

In- and exclusion criteria of the randomised controlled trial for Competencecenter of Transcultural Psychiatry:

Inclusion criteria:

* Adult (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.
* 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).

Where it's running

  • Mental Health Centre Ballerup
    Ballerup Municipality, Capital Region, Denmark
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.