Trauma-Focused Group Therapy for Adults With Trauma-Related Symptoms in Primary Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLuis Eduardo Estévez Cachafeiro
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Acute psychotic decompensation.
Active suicidal ideation requiring immediate and intensive clinical intervention.
Unstable problematic substance use.
Unstable comorbid severe mental disorder.
Trial design
Design model
Parallel
Treatments tested in this trial
Trauma-Focused Group Intervention
BehavioralA 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.
Treatment as Usual (TAU)
Other interventionUnstructured 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 groups
150 Participants
are divided into 2 treatment groupsGroup A: Trauma-Focused Group InterventionExperimental treatment 1 intervention
Group B: Treatment as Usual Wait-List ControlActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline (T0) and post-intervention (10 weeks) (T1)Secondary outcomes
1
Change in general psychological distress and functioning
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.
Time frame
Baseline (T0) and post-intervention (10 weeks) (T1)2
Change in ICD-11 complex post-traumatic stress symptoms
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.
Time frame
Baseline (T0) and post-intervention (10 weeks) (T1)3
Change in emotion regulation
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.
Time frame
Baseline (T0) and post-intervention (10 weeks) (T1)4
Maintenance of post-traumatic stress symptom improvement
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.
Time frame
post-intervention (10 weeks) (T1) and 3-month follow-up (T2)Other outcomes
1
Lifetime trauma exposure
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.
Time frame
Baseline (T0)2
Adult Attachment Representations
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.
Time frame
Baseline (T0)3
Treatment adherence
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.
Time frame
Throughout the intervention period (10 weeks)4
Treatment completion
Treatment completion will be assessed as the number and proportion of participants who complete the intervention according to the predefined study criteria.
Time frame
post-intervention (10 weeks) (T1)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Luis Eduardo Estévez Cachafeiro
Lead sponsor
University Ramon Llull
Sponsor institution
Fundació Vidal i Barraquer
Collaborator
Source ClinicalTrials.gov