Trauma-Focused Group Therapy for Adults With Trauma-Related Symptoms in Primary Care

NCT07757334 | Not Yet Recruiting

• 1 other identifier: 2526016D
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychological Trauma; Stress Disorders, Post-Traumatic; Mental Disorders

Keywords

Psychological trauma; Trauma-focused therapy; Eye Movement Desensitization and Reprocessing; Sensorimotor Psychotherapy; Group psychotherapy; Primary care; Adults; Collaborative stepped care; Pragmatic Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in post-traumatic stress symptom severity

  Post-traumatic stress symptom severity will be assessed using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), a 20-item self-report questionnaire that measures the severity of DSM-5 post-traumatic stress disorder symptoms across the domains of intrusion, avoidance, negative alterations in cognition and mood, and alterations in arousal and reactivity. Total scores range from 0 to 80, with higher scores indicating greater post-traumatic stress symptom severity.

  Baseline (T0) and post-intervention (10 weeks) (T1)

Secondary Outcomes (8)

• Change in general psychological distress and functioning

  Baseline (T0) and post-intervention (10 weeks) (T1)

• Change in ICD-11 complex post-traumatic stress symptoms

  Baseline (T0) and post-intervention (10 weeks) (T1)

• Change in emotion regulation

  Baseline (T0) and post-intervention (10 weeks) (T1)

• Maintenance of post-traumatic stress symptom improvement

  post-intervention (10 weeks) (T1) and 3-month follow-up (T2)

• Maintenance of general psychological distress

  post-intervention (10 weeks) (T1) and 3-month follow-up (T2)

Other Outcomes (6)

• Lifetime trauma exposure

  Baseline (T0)

• Adult Attachment Representations

  Baseline (T0)

• Treatment adherence

  Throughout the intervention period (10 weeks)

Study Arms (2)

Trauma-Focused Group Intervention

EXPERIMENTAL

Participants allocated to this arm will receive the trauma-focused group intervention immediately after baseline assessment. The intervention is delivered within a collaborative stepped-care model in primary care and integrates evidence-informed principles from Eye Movement Desensitization and Reprocessing (EMDR) and Sensorimotor Psychotherapy. Clinical outcomes will be assessed at baseline (T0), post-intervention (T1), and follow-up.

Behavioral: Trauma-Focused Group Intervention

Treatment as Usual Wait-List Control

ACTIVE COMPARATOR

Participants allocated to this arm will receive treatment as usual (TAU) during the study period until completion of the primary post-intervention assessment (T1). After completion of the T1 assessment, participants will be offered the trauma-focused group intervention for ethical reasons. Clinical outcomes will be assessed at baseline (T0), post-intervention (T1), and follow-up.

Other: Treatment as Usual (TAU)

Interventions

Trauma-Focused Group Intervention BEHAVIORAL

A manualized trauma-focused group intervention delivered within a collaborative stepped-care model in primary care. The intervention integrates evidence-informed principles from Eye Movement Desensitization and Reprocessing (EMDR) and Sensorimotor Psychotherapy within a phased treatment framework consisting of stabilization, trauma processing, and integration. The intervention is delivered in a structured group format.

Also known as: phase 1 trauma-focused group intervention

Trauma-Focused Group Intervention

Treatment as Usual (TAU) OTHER

Unstructured treatment as usual (TAU) according to routine clinical practice. TAU may include follow-up by clinical psychologists and/or psychiatrists within the Primary Care Collaborative Program (PCP). Healthcare contacts during the study period will be recorded.

Treatment as Usual Wait-List Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luis Eduardo Estévez Cachafeiro: lead
• Fundació Vidal i Barraquer: collaborator

Study Sites (1)

Centre de Salut Mental d'Adults de Sant Andreu

Barcelona, Barcelona, 08030, Spain

Location

MeSH Terms

Conditions

Psychological Trauma; Stress Disorders, Traumatic; Mental Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders

Study Officials

• Luis E Estévez-Cachafeiro, Clinical Psychologist

  Facultat de Psicologia, Ciències de l'Educació i de l'Esport Blanquerna Universitat Ramon Llull

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis E Estévez-Cachafeiro, Clinical Psychologist

CONTACT

+34 629583806; luiseduardoec@blanquerna.url.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not feasible due to the nature of the psychological group intervention. Participants, therapists, and investigators are aware of treatment allocation. Outcomes are assessed using standardized self-report questionnaires completed by participants at baseline, post-intervention, and follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Psychologist

Model Details: Participants will be randomly assigned in a 1:1 ratio to either an immediate trauma-focused group intervention or a wait-list control receiving treatment as usual (TAU) until the primary post-intervention assessment (T1). Randomization will be performed using permuted blocks and stratified according to baseline post-traumatic stress symptom severity. Clinical outcomes will be assessed at baseline (T0), post-intervention (T1), and follow-up. For ethical reasons, participants allocated to the wait-list control group will be offered the trauma-focused group intervention after completion of the T1 assessment. This pragmatic design enables evaluation of the intervention under routine primary care conditions while ensuring that all participants have access to the intervention.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: August 11, 2026

Record last verified: 2026-08

Locations

ES (1)