Trauma-Focused Group Therapy for Adults With Trauma-Related Symptoms in Primary Care (NCT07757334) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Trauma-Focused Group Therapy for Adults With Trauma-Related Symptoms in Primary Care
Spain150 participantsStarted 2026-09
Plain-language summary
Psychological trauma is common and can lead to long-lasting emotional distress, difficulties in daily functioning, and reduced quality of life. Despite the availability of effective psychological treatments, access to trauma-focused interventions in primary care remains limited.
This study will evaluate the effectiveness and feasibility of a trauma-focused group intervention delivered within a collaborative stepped-care model in primary care. Adults with trauma-related symptoms will be randomly assigned to either receive the trauma-focused group intervention or treatment as usual. The intervention integrates evidence-informed principles from Eye Movement Desensitization and Reprocessing (EMDR) and Sensorimotor Psychotherapy and is delivered in a structured group format.
The study hypothesizes that participants receiving the trauma-focused group intervention will show greater improvements in trauma-related symptoms, emotional regulation, psychological distress, functioning, quality of life, and treatment satisfaction than participants receiving treatment as usual. The study will also evaluate implementation outcomes, including acceptability, feasibility, and participant engagement, to determine whether this intervention can improve access to trauma-focused care within the public healthcare system.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in post-traumatic stress symptom severity
Timeframe: Baseline (T0) and post-intervention (10 weeks) (T1)