Improving PTSD treatment through patient engagement strategies
Patient Engagement in PTSD Treatment (PEP) - Advancing PTSD Treatment Outcomes
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 427 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital Academic / other |
| Locations | 1 site (Ballerup Municipality, Capital Region) |
| Trial ID | NCT06755710 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe psychotic disorders or active substance dependence may not benefit from this study.
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 performed: Previous studies have indicated that enhancing motivation and employing shared decision-making can positively impact treatment outcomes, suggesting a promising approach.
Eligibility criteria
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 this trial is running
Ballerup Municipality, Capital Region
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.