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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 427 (estimated) |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 1 site (Ballerup Municipality, Capital Region) |
| Status | Recruiting |
| Started | January 2, 2025 |
| Main results expected | February 29, 2028 |
| Study ends | August 31, 2028 |
| Registry record updated | July 14, 2026 |
| Trial ID | NCT06755710 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
- Study coordinator: Anna Bolette L. Nielsen, Medical Doctor
- Email: anna.bolette.lund.nielsen.03@regionh.dk
- Phone: +4538646181
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.