Group-based Metacognitive Therapy for PTSD in routine psychiatric care.
A Feasibility Study of Group-Based Metacognitive Therapy (MCT) for Post-Traumatic Stress Disorder (PTSD) in a Routine Healthcare Setting
This project will try group-based Metacognitive Therapy (MCT) for adults with PTSD to see if people accept the treatment and whether symptoms and quality of life improve when it is offered in routine psychiatric care in Sweden.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT07302334 on ClinicalTrials.gov |
What this trial studies
Participants will attend 14 weekly group MCT sessions delivered at a specialized psychiatric clinic in Stockholm with broadly inclusive recruitment and minimal exclusion criteria. Primary outcomes focus on feasibility and acceptability, including recruitment and retention rates, data completeness, treatment adherence, and qualitative feedback from participants. Secondary outcomes will measure preliminary changes in PTSD, complex PTSD, depressive symptoms, and quality of life, and will compare dropout rates to those reported for exposure-based PTSD treatments. Outcomes will be measured from pre-treatment to post-treatment and at a 6-month follow-up.
Who should consider this trial
Good fit: Adults (≥18) with a clinical diagnosis of PTSD, a self-rated PCL-5 total score over 30, stable psychotropic medication for at least 4 weeks, fluent in Swedish, and not currently receiving evidence-based trauma-focused therapy are ideal candidates.
Not a fit: Patients with severe psychiatric comorbidities requiring immediate attention (such as active suicidal ideation, psychosis, or bipolar disorder), those facing an ongoing trauma-related threat, or those already in trauma-focused therapy are unlikely to benefit from or be eligible for this program.
Why it matters
Potential benefit: If successful, group MCT could provide an acceptable, more scalable treatment option that reduces PTSD and depressive symptoms and improves functioning and quality of life for patients in routine care.
How similar studies have performed: Metacognitive Therapy has shown promising results for anxiety, depression, and some individual PTSD studies, but group-based MCT for PTSD delivered within routine psychiatric settings is relatively novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fulfills the diagnostic criteria for PTSD based on clinical records * Self-rated total sum score over 30 on the PCL-5 * Age ≥18 years. * Stable psychotropic medication regimen for ≥4 weeks. * Fluent in Swedish. Exclusion Criteria: * Severe psychiatric comorbidities (e.g., suicidal ideation, active psychosis, bipolar disorder) warranting immediate attention. * Current trauma-related threat (e.g., ongoing domestic violence). * Ongoing evidence-based trauma-focused psychological treatment
Where this trial is running
Stockholm
- Affektiva, ångest och traumaprogrammet, Psykiatri Sydväst — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Maria Bragesjö
- Email: maria.bragesjo@ki.se
- Phone: +46703399387
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.