Trauma-focused group therapy for adults with trauma symptoms in primary care
Official title: Effectiveness of a Trauma-Focused Group Intervention Within a Collaborative Stepped-Care Model in Primary Care: A Pragmatic Randomized Controlled Trial
Run by University Ramon Llull · NCT07757334 · Data updated 2026-11-12
A group-based trauma therapy delivered in primary care to see if it helps adults with trauma-related symptoms more than usual care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University Ramon Llull Academic / other |
| Locations | 1 site (Barcelona, Barcelona) |
| Status | Recruiting |
| Started | August 25, 2026 |
| Main results expected | October 2028 |
| Study ends | January 2029 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT07757334 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with PTSD or trauma-related symptoms who are enrolled in the Primary Care Collaborative Program and speak Spanish or Catalan.
✕Probably not a fit
Patients without trauma-related symptoms or with conditions that make group participation unsafe or impractical may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pragmatic randomized trial tests a trauma-focused group intervention, combining EMDR and Sensorimotor Psychotherapy principles, within a collaborative stepped-care model in primary care. Adults referred from primary care with PTSD or related trauma symptoms are randomized to receive the group intervention or treatment as usual. The study aims to measure changes in trauma symptoms, emotional regulation, psychological distress, functioning, and quality of life. The intervention emphasizes stabilization, trauma processing, and integration in a structured group setting to improve accessibility in routine healthcare. Assessments will track feasibility, safety, and real-world applicability in a public mental health service.
Why it matters
Potential benefit: If successful, the group intervention could improve trauma-related symptoms and daily functioning and increase access to evidence-based care in primary care settings.
How similar studies have gone: Prior trauma-focused therapies like EMDR have shown benefit, but delivery as a structured group in primary care is less established and the practical, stepped-care approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Currently enrolled in the Primary Care Collaborative Program (PCP) of the Sant Andreu Mental Health District. * Diagnosis of post-traumatic stress disorder (PTSD) or the presence of symptoms consistent with trauma-related psychopathology, including PTSD, prolonged stress, complex PTSD (CPTSD), relational trauma, or other trauma-related symptoms associated with adverse life experiences. * Sufficient proficiency in Spanish or Catalan to understand the intervention and complete the study assessments. * Ability and willingness to provide written informed consent. Exclusion Criteria: * Acute psychotic decompensation. * Active suicidal ideation requiring immediate and intensive clinical intervention. * Unstable problematic substance use. * Unstable comorbid severe mental disorder. * Significant cognitive impairment or intellectual or physical disability that would interfere with participation in the group intervention or understanding of the study procedures.
Where it's running
-
Centre de Salut Mental d'Adults de Sant Andreu
Barcelona, Barcelona, Spain Recruiting
Study contacts
- Principal investigator: Luis E Estévez-Cachafeiro, Clinical Psychologist — Facultat de Psicologia, Ciències de l'Educació i de l'Esport Blanquerna Universitat Ramon Llull
- Study coordinator: Luis E Estévez-Cachafeiro, Clinical Psychologist
- Email: luiseduardoec@blanquerna.url.edu
- Phone: +34 629583806
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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.