Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07757334

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Psychological Trauma Mental Disorders Stress Disorders, Post-Traumatic; Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Salut Mental d'Adults de Sant Andreu

Barcelona, 08030, Spain

Location contact

Centre de Salut Mental d'Adults de Sant Andreu

CONTACT

[email protected]

+34 936243458

About this study

Psychological trauma is highly prevalent and is associated with substantial psychiatric and physical morbidity, functional impairment, reduced quality of life, and increased healthcare utilization. In primary care, trauma-related disorders are frequently underrecognized because of their heterogeneous clinical presentation, high rates of comorbidity, and organizational barriers that limit access to evidence-based psychological treatments. Although trauma-focused interventions such as Eye Movement Desensitization and Reprocessing (EMDR) are recommended by international clinical guidelines, their implementation in routine primary care remains limited.

To address this gap, this study evaluates a trauma-focused group intervention implemented within a collaborative stepped-care model in primary care. The intervention integrates evidence-informed principles from EMDR and Sensorimotor Psychotherapy within a phased treatment framework emphasizing stabilization, trauma processing, and integration. The group format was selected to improve accessibility, facilitate implementation in routine healthcare settings, and increase the capacity of public mental health services while maintaining a trauma-informed approach.

This is a pragmatic randomized controlled trial conducted in adults presenting with trauma-related symptoms referred from primary care. Participants will be randomly allocated to receive either the trauma-focused group intervention or treatment as usual. Clinical assessments will be performed at baseline, post-intervention, and follow-up to evaluate changes over time.

The primary objective is to determine whether the trauma-focused group intervention is more effective than treatment as usual in reducing trauma-related symptoms. Secondary objectives include evaluating improvements in emotion regulation, psychological distress, functional impairment, quality of life, and treatment satisfaction. The study will also assess implementation outcomes, including feasibility, acceptability, participant engagement, and the potential integration of the intervention within routine primary care services.

This trial is intended to generate clinically relevant and implementation-focused evidence regarding the effectiveness and scalability of a trauma-focused group intervention delivered in real-world primary care. The findings may contribute to improving access to evidence-based trauma treatment and support the development of collaborative stepped-care models within public healthcare systems.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: phase 1 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.

Primary outcomes

  1. Change in post-traumatic stress symptom severity

    Time frame: Baseline (T0) and post-intervention (10 weeks) (T1)

    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.

Secondary outcomes

  1. Change in general psychological distress and functioning

    Time frame: Baseline (T0) and post-intervention (10 weeks) (T1)

    Change in general psychological distress and functioning assessed using the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM), a 34-item self-report questionnaire assessing subjective well-being, psychological symptoms, functioning, and risk. Total scores range from 0 to 136, with higher scores indicating greater psychological distress and functional impairment.

  2. Change in ICD-11 complex post-traumatic stress symptoms

    Time frame: Baseline (T0) and post-intervention (10 weeks) (T1)

    Change in ICD-11 post-traumatic stress disorder (PTSD) and complex PTSD symptoms assessed using the International Trauma Questionnaire (ITQ). The ITQ is a self-report questionnaire that assesses the core PTSD symptom clusters and disturbances in self-organization, including affective dysregulation, negative self-concept, and disturbances in relationships. Higher scores indicate greater symptom severity.

  3. Change in emotion regulation

    Time frame: Baseline (T0) and post-intervention (10 weeks) (T1)

    Change in emotion regulation assessed using the Difficulties in Emotion Regulation Scale (DERS). The DERS is a self-report questionnaire assessing multiple domains of emotion regulation difficulties. Higher scores indicate greater difficulties in emotion regulation.

  4. Maintenance of post-traumatic stress symptom improvement

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

    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.

  5. Maintenance of general psychological distress

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

    Change in general psychological distress and functioning assessed using the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM), a 34-item self-report questionnaire assessing subjective well-being, psychological symptoms, functioning, and risk. Total scores range from 0 to 136, with higher scores indicating greater psychological distress and functional impairment.

  6. Maintenance in ICD-11 complex post-traumatic stress symptoms

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

    Change in ICD-11 post-traumatic stress disorder (PTSD) and complex PTSD symptoms assessed using the International Trauma Questionnaire (ITQ). The ITQ is a self-report questionnaire that assesses the core PTSD symptom clusters and disturbances in self-organization, including affective dysregulation, negative self-concept, and disturbances in relationships. Higher scores indicate greater symptom severity.

  7. Maintenance in emotion regulation

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

    Change in emotion regulation assessed using the Difficulties in Emotion Regulation Scale (DERS). The DERS is a self-report questionnaire assessing multiple domains of emotion regulation difficulties. Higher scores indicate greater difficulties in emotion regulation.

  8. Treatment satisfaction

    Time frame: post-intervention (10 weeks) (T1)

    Participant satisfaction with the trauma-focused group intervention will be assessed using the Client Satisfaction Scale (CRES-4), a brief self-report questionnaire evaluating participants' satisfaction with the treatment received. Higher scores indicate greater treatment satisfaction.

Other outcomes

  1. Lifetime trauma exposure

    Time frame: Baseline (T0)

    Lifetime trauma exposure will be assessed at baseline using the International Trauma Exposure Measure (ITEM), a structured self-report questionnaire that evaluates exposure to potentially traumatic events across childhood, adolescence, and adulthood. The instrument is used to characterize cumulative trauma exposure and explore its association with treatment outcomes. Higher scores indicate greater lifetime trauma exposure.

  2. Adult Attachment Representations

    Time frame: Baseline (T0)

    Adult attachment representations will be assessed at baseline using the Reduced Adult Attachment Questionnaire (CaMir-R), a self-report questionnaire assessing attachment-related cognitions, experiences with attachment figures, and family functioning across seven dimensions. The instrument provides dimensional estimates of secure, preoccupied, and avoidant attachment representations and will be used to characterize the study population and explore associations with treatment outcomes.

  3. Treatment adherence

    Time frame: Throughout the intervention period (10 weeks)

    Treatment adherence will be assessed as the proportion of scheduled group sessions attended by each participant. Higher percentages indicate greater adherence to the intervention protocol.

  4. Treatment completion

    Time frame: post-intervention (10 weeks) (T1)

    Treatment completion will be assessed as the number and proportion of participants who complete the intervention according to the predefined study criteria.

  5. Participant retention

    Time frame: Baseline (T0) through 3-month follow-up (T2)

    Participant retention will be assessed as the number and proportion of participants who complete the scheduled outcome assessments during the study. Higher retention rates indicate greater participant engagement throughout the trial.

  6. Healthcare pathway after intervention

    Time frame: Baseline (T0) through 3-month follow-up (T2)

    Participants' progression within the collaborative stepped-care model will be recorded, including completion of the intervention, need for additional treatment phases, referral to higher levels of mental healthcare, or discharge following completion of the stepped-care pathway.

Study contacts

Contact information is provided by the study sponsor or research team.

Luis E Estévez-Cachafeiro, Clinical Psychologist

CONTACT

[email protected]

+34 629583806

Sponsors and collaborators

Lead sponsor

Luis Eduardo Estévez Cachafeiro

Other

Collaborators

  • Fundació Vidal i Barraquer

Registry information

Official study title

Effectiveness of a Trauma-Focused Group Intervention Within a Collaborative Stepped-Care Model in Primary Care: A Pragmatic Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.