Psychological TraumaNCT07757334
Trauma-Focused Group Therapy for Adults With Trauma-Related Symptoms in Primary Care
A study testing Trauma-Focused Group Intervention and Treatment as Usual (TAU) in people with Psychological Trauma and Stress Disorders, Post-Traumatic; Mental Disorders, run by Luis Eduardo Estévez Cachafeiro at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Trauma, Stress Disorders, Post-Traumatic; Mental Disorders
- What is being tested?
- Trauma-Focused Group Intervention and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 25 Aug 2026to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Luis E Estévez-Cachafeiro, Clinical Psychologist contact
Spain1 site, 1 recruiting
- Recruiting
Centre de Salut Mental d'Adults de Sant Andreu
Barcelona, Barcelona, 08030
Centre de Salut Mental d'Adults de Sant Andreu, +34 936243458, csma_usuaris@fvb.cat
About this study
Official title: Effectiveness of a Trauma-Focused Group Intervention Within a Collaborative Stepped-Care Model in Primary Care: A Pragmatic Randomized Controlled 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.
Read the detailed description
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.
- Being tested
- Trauma-Focused Group Intervention, Treatment as Usual (TAU)
- 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
- Medical subject headings
- Psychological Trauma, Stress Disorders, Traumatic, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Focused Group InterventionBehavioural
Also called phase 1 trauma-focused group intervention
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0) and post-intervention (10 weeks) (T1)
Secondary outcomes (8)
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.
Measured: Baseline (T0) and post-intervention (10 weeks) (T1)
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.
Measured: Baseline (T0) and post-intervention (10 weeks) (T1)
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.
Measured: Baseline (T0) and post-intervention (10 weeks) (T1)
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.
Measured: post-intervention (10 weeks) (T1) and 3-month follow-up (T2)
Maintenance of general psychological distress
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.
Measured: post-intervention (10 weeks) (T1) and 3-month follow-up (T2)
Maintenance 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.
Measured: post-intervention (10 weeks) (T1) and 3-month follow-up (T2)
Maintenance 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.
Measured: post-intervention (10 weeks) (T1) and 3-month follow-up (T2)
Treatment satisfaction
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.
Measured: post-intervention (10 weeks) (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start25 Aug 2026
- Primary completionOct 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 by (1) the presence or absence of ICD-11 Complex Post-Traumatic Stress Disorder (CPTSD), as assessed with the International Trauma Questionnaire (ITQ), and (2) time-slot availability declared before randomization (morning vs. afternoon). 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luis Eduardo Estévez Cachafeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Vidal i Barraquer
- Responsible party
- Sponsor-investigator, Luis Eduardo Estévez Cachafeiro, University Ramon Llull
- Investigators
- Luis E Estévez-Cachafeiro, Clinical Psychologist, Principal investigator, Facultat de Psicologia, Ciències de l'Educació i de l'Esport Blanquerna Universitat Ramon Llull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757334
- Sponsor's protocol ID
- 2526016D
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have not yet determined whether individual participant data will be shared. A decision will be made after study completion, taking into account ethical approvals, participant consent, institutional policies, and applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Trauma-Focused Group Intervention Within a Collaborative Stepped-Care Model in Primary Care: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07757334
- Acronym / sponsor ID
- 2526016D
- Keywords
- Psychological trauma, Trauma-focused therapy, Eye Movement Desensitization and Reprocessing, Sensorimotor Psychotherapy, Group psychotherapy, Primary care, Adults, Collaborative stepped care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Luis Eduardo Estévez CachafeiroUniversity, hospital or other
- Collaborators
- Fundació Vidal i Barraquer
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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 by (1) the presence or absence of ICD-11 Complex Post-Traumatic Stress Disorder (CPTSD), as assessed with the International Trauma Questionnaire (ITQ), and (2) time-slot availability declared before randomization (morning vs. afternoon). 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.
| Arm | Type | Receives |
|---|---|---|
| Trauma-Focused Group Intervention | Experimental | Behavioral: Trauma-Focused Group InterventionParticipants 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. |
| Treatment as Usual Wait-List Control | Active comparator | Other: Treatment as Usual (TAU)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma-Focused Group InterventionAlso: phase 1 trauma-focused group interventionA 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. | Behavioural | Trauma-Focused Group Intervention |
| Treatment as Usual (TAU)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. | Other | Treatment as Usual Wait-List Control |
Primary outcome
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.
8 secondary outcomes
Change in general psychological distress and functioning
Time frame: Baseline (T0) and post-intervention (10 weeks) (T1)
Change in ICD-11 complex post-traumatic stress symptoms
Time frame: Baseline (T0) and post-intervention (10 weeks) (T1)
Change in emotion regulation
Time frame: Baseline (T0) and post-intervention (10 weeks) (T1)
Maintenance of post-traumatic stress symptom improvement
Time frame: post-intervention (10 weeks) (T1) and 3-month follow-up (T2)
Maintenance of general psychological distress
Time frame: post-intervention (10 weeks) (T1) and 3-month follow-up (T2)
Maintenance in ICD-11 complex post-traumatic stress symptoms
Time frame: post-intervention (10 weeks) (T1) and 3-month follow-up (T2)
Maintenance in emotion regulation
Time frame: post-intervention (10 weeks) (T1) and 3-month follow-up (T2)
Treatment satisfaction
Time frame: post-intervention (10 weeks) (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided. The investigators have not yet determined whether individual participant data will be shared. A decision will be made after study completion, taking into account ethical approvals, participant consent, institutional policies, and applicable data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luis E Estévez-Cachafeiro, Clinical Psychologist contact
Luis E Estévez-Cachafeiro, Clinical Psychologist principal investigator
Facultat de Psicologia, Ciències de l'Educació i de l'Esport Blanquerna Universitat Ramon Llull
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-Focused Group Intervention and Treatment as Usual (TAU) in people with Psychological Trauma and Stress Disorders, Post-Traumatic; Mental Disorders, run by Luis Eduardo Estévez Cachafeiro at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis E Estévez-Cachafeiro, Clinical Psychologist (+34 629583806, luiseduardoec@blanquerna.url.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in post-traumatic stress symptom severity (time frame: Baseline (T0) and post-intervention (10 weeks) (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.