Trauma, PsychologicalHEALING-TRAUMANCT07897903
Group Cognitive Processing Therapy for Women Survivors of Gender-Based Violence: Feasibility Study
A study testing Group CPT + TAU (Experimental) in people with Trauma, Psychological and Traumatic Stress Disorder, run by Universidad Complutense de Madrid.
Trial summary
Introduction: Post-traumatic stress disorder (PTSD) is a global health challenge requiring effective, evidence-based interventions, such as Cognitive Processing Therapy (CPT). Although clinical guidelines position individual CPT as a first-line treatment, evidence regarding its group format -despite it being the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Trauma, Psychological, Traumatic Stress Disorder
- What is being tested?
- Group CPT + TAU (Experimental)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 1 Jul 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Exposure to at least one traumatic event (ITEM).
- Active posttraumatic symptoms related to the event (PCL-5 score above cut-off >= 30).
- Women in active psychological treatment at Grupo ABD, referred by their therapist.
Who cannot join
- Active suicidal ideation at screening session (PHQ-9 item 9 and clinical judgment).
- Intellectual disability or severe cognitive impairment.
- Inability to commit to the intervention.
- Concurrent trauma-focused individual or group psychotherapy (e.g., Prolonged Exposure, EMDR, CPT).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Healing Trauma From Gender-based Violence Through Group Cognitive Processing Therapy: A Single-Arm Feasibility Study (Phase 1)
Introduction: Post-traumatic stress disorder (PTSD) is a global health challenge requiring effective, evidence-based interventions, such as Cognitive Processing Therapy (CPT). Although clinical guidelines position individual CPT as a first-line treatment, evidence regarding its group format -despite it being the original modality- remains limited. Given the potential of the group format to optimize costs and improve access to treatment in high-demand health systems, evaluating its feasibility and clinical efficacy is a priority.
Objectives: The project proposes a phased research study focused on the implementation, scalability, and clinical impact of group CPT for women who are victims of gender-based violence and exhibit post-traumatic symptoms. Phase 1 (feasibility study) aims to evaluate the acceptability and feasibility of the group CPT protocol.
Read more
Methodology: Phase 1 will involve a non-randomized pilot study with female victims of gender-based violence with post-traumatic symptomatology; participants will receive 12 sessions of group CPT. Feasibility will be assessed in this phase based on recruitment rates, adherence, and participant satisfaction. Clinical outcomes (PTSD symptoms, general psychopathology, emotional regulation, and well-being) will be measured at three time points (pre-intervention, post-intervention, and six-month follow-up) using validated instruments.
Expected Results: "Healing Trauma"'s Phase 1 anticipates demonstrating high protocol feasibility and acceptability, as well as a clinically significant reduction in PTSD symptoms and the other measured variables. Furthermore, the project expects to produce a standardized intervention manual that could, in the future, be revised for adaptation and transfer to other psychological care units.
Significance: The project will provide an optimized and scalable group CPT protocol, facilitating the democratization of access to evidence-based treatments -particularly in high-demand health systems- while fostering clinical psychological practice grounded in evidence and scientific rigor.
Read the detailed description
Background: Seven in ten people will experience a traumatic event in their lifetime; PTSD prevalence among women exposed to gender-based violence is estimated at 30-70%. Guidelines (NICE 2018, APA 2017, WHO 2013) recommend trauma-focused therapies, with CPT as a preferred first-line option. Group CPT could treat up to four times more patients with the same human resources, while simultaneously reducing isolation and normalizing trauma-related cognitions.
Intervention: 12 weekly 90-minute protocolized CPT group (8-10 participants) sessions led by two therapists trained in the protocol. CPT works with postraumatic symptoms through 1) training of cognitive restructuring techniques such as Socratic dialogue and ABC registers, 2) weekly homework and 3) psychoeducation across five themes usually affected after experiencing a traumatic event: safety, trust, power/control, esteem and intimacy. Participants complete one PCL-5 and PHQ-9 register at the start of each session.
Procedure: Grupo ABD therapists refer women in active psychological treatment who show posttraumatic symptoms. A screening session (sociodemographic form, ITEM, PCL-5, PHQ-9) is followed by an individual pre-intervention assessment by the research team (CAPS-5 interview, identification of the index trauma, and ITQ, SA-45, SPWB, SWLS and CERQ). The same battery is repeated post-treatment (plus CSQ) and at 6 months.
- Conditions
- Trauma, Psychological, Traumatic Stress Disorder
- Being tested
- Group CPT + TAU (Experimental)
- Keywords
- Trauma, Traumatic Stress Disorder, Cognitive Processing Therapy, Group Psychotherapy
- Medical subject headings
- Psychological Trauma, Stress Disorders, Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group CPT + TAU (Experimental)Behavioural
Group Cognitive Processing Therapy. 12 weekly 90-minute sessions, 8-10 participants, 1-2 trained co-therapists, Spanish translation of the Resick CPT manual; fidelity checklist and group supervision; between-session phone list; individual recap session for missed sessions.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Processing Therapy Group Intervention | Experimental | Group Cognitive Processing Therapy. 12 weekly 90-minute sessions, 8-10 participants, 1-2 trained co-therapists, Spanish translation of the Resick, Monson \& Chard (2017) CPT manual; fidelity checklist and group supervision; between-session phone list; individual recap session for missed sessions.
Sessions include: psychoeducation and individual worksheets based on cognitive reestructuring techniques Receives: Behavioral: Group CPT + TAU (Experimental) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment retention/adherence
Proportion of enrolled participants who complete the intervention (participants retention/adherance >= 75%).
Measured: At the beginning of each session (all 12 weeks)
Recruitment rate
Participants enrolled
Measured: Recruitment period
Mean number of sessions attended and attrition rate
Measured: At the beginning of each session (all 12 weeks)
Client Satisfaction Questionnaire
Acceptability will be assessed after the intervention using a participant satisfaction questionnaire (CSQ-8). The questionnaire will evaluate participants' perceived usefulness, relevance, comprehensibility, and overall satisfaction with the intervention. 8 items rated from 1 to 4. Total score ranges from 8 to 32. Higher scores indicate greater satisfaction and acceptability (better outcome).
Measured: Immediately after the intervention (week 12)
Secondary outcomes (9)
Change in PTSD/CPTSD symptoms (I) at 12 weeks and 6 months
PTSD Checklist for DSM-5 (PCL-5; Weathers et al., 2013).
- 20 items rated from 0 (not at all) to 4 (extremely). Total score ranges from 0 to 80.
- Higher scores indicate a worse outcome (more severe symptoms).
Measured: Baseline, at the beginning of each session, end of treatment (week 12), and 6-month follow-up
Change in PTSD/CPTSD symptoms (II) at 12 weeks and 6 months
International Trauma Questionnaire (ITQ; Cloitre et al., 2018).
- 12 symptom items (6 PTSD, 6 Disturbances in Self-Organization) rated from 0 (not at all) to 4 (extremely). Symptom total score ranges from 0 to 48 (each of the two sets of items from 0 to 24).
- Higher scores indicate a worse outcome (more severe symptoms).
Measured: Baseline, end of treatment (week 12), and 6-month follow-up
Change in PTSD/CPTSD symptoms (III) at 12 weeks and 6 months
Impact of Trauma Questionnaire (Spanish questionnaire; "Cuestionario de Impacto del Trauma", CIT; Crespo, González-Ordi, Gómez-Gutiérrez, Santamaría, 2020).
- 180 items related to different scales on PTSD symptomatology and comorbid symptomatology rated from 1 (never) to 5 (always).
- Higher scores mean worse outcome (more severe symptoms).
Measured: Baseline, end of treatment (week 12), and 6-month follow-up
Change from psychopathological symptoms at 12 weeks and 6 months
Symptom Assessment-45 Questionnaire (SA-45; Davison et al., 1997), a brief version of the Symptom Checklist-90-Revised (SCL-90-R).
- 45 items rated from 0 (not at all) to 4 (a lot). It covers a total of 9 different symptomatic areas (e.g. depression, anxiety, interpersonal sensibility) and gives an overall severity score. Total score ranges from [0 to 180].
- Higher scores indicate a worse outcome (more severe symptoms).
Measured: Baseline, end of treatment (week 12), and 6-month follow-up
Change from Well-being at 12 weeks and 6 months
Ryff's Scales of Psychological Well-Being (Ryff \& Keyes, 1995).
- 29 items rated from 1 (strongly disagree) to 6 (strongly agree). The SPWB evaluates 6 dimensions of psychological well-being: Self-acceptance, Positive relationships, Autonomy, Environmental mastery, Life purpose, and Personal growth. Scores ranges differ from scale to scale:
- Self-acceptance [4-24]
- Positive relationships [5-30]
- Autonomy [6-36]
- Environmental mastery [5-30]
- Life purpose [4-24]
- Personal growth [5-30]
- Higher scores indicate a better outcome (more psychological wellbeing).
Measured: Baseline, end of treatment (week 12), and 6-month follow-up
Change from Satisfaction with life at 12 weeks and 6 months
Satisfaction with Life Scale (SWLS; Diener et al., 1985).
- 5 items rated from 1 (strongly disagree) to 7 (strongly agree). Total score ranges from 5 to 35.
- Higher scores indicate a better outcome (more satisfaction with life).
Measured: Baseline, end of treatment (week 12), and 6-month follow-up
Change from Emotion Regulation at 12 weeks and 6 months
Cognitive Emotion Regulation Questionnaire-short (CERQ-short; Garnefski \& Kraaij, 2007).
- 18 items rated from 1 (almost never) to 5 (almost always). The CERQ-short evaluates 9 dimensions (composed by 2 items each): Self-blame, Acceptance, Rumination, Positive refocusing, Refocus on planning, Positive reappraisal, Putting into perspectiva, Catastrophizing, and Other-blame. Each dimension ranges from 5 to 10. Also, two big dimensions are calculated depending on the type of strategy:
- Sum of the adaptive subscales (acceptance, positive refocusing, refocus on planning, positive reappraisal, putting into perspective; 10 items) ranges from 10 to 50. Higher scores indicate a better outcome.
- Sum of the maladaptive subscales (self-blame, rumination, catastrophizing, other-blame; 8 items) ranges from 8 to 40. Higher scores indicate a worse outcome.
Measured: Baseline, end of treatment (week 12), and 6-month follow-up
Change from Self-care at 12 weeks and 6 months
Self-Care Scale (Spanish instrument; "Escala de autocuidado", Gonzalez et al., 2017),
- 31 items rated from 1 (completely disagre) to 7 (completely agree). The scale evaluates dimensions: Self-destructive behaviors, Non-tolerance towards positive affect, Issues accepting help, Resentment due to non-reciprocity, No positive activities, and None attendace towards personal needs.
- Higher scores indicate worse self-care.
Measured: Baseline, end of treatment (week 12), and 6-month follow-up
Change from depression at 12 weeks and 6 months
Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001).
- 9 items rated from 0 (not at all) to 3 (nearly every day). Total score ranges from 0 to 27.
- Higher scores indicate a worse outcome (more severe symptoms).
Measured: Baseline, at the beginning of each session, end of treatment (week 12), and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion20 Oct 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trauma, PsychologicalStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the same 12 weekly CPT group sessions. Assessments will be conducted before, after the intervention and at a 6-months follow-up, with no concurrent comparator group.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Grupo ABD
- Responsible party
- Principal investigator, Carmen Valiente Ots, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897903
- Sponsor's protocol ID
- HT-F1-2026
- Acronym
- HEALING-TRAUMA
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Resick, P. A., Monson, C. M., & Chard, K. M. (2024). Cognitive processing therapy for PTSD: A comprehensive therapist manual (2nd ed.). Guilford Press
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Trauma From Gender-based Violence Through Group Cognitive Processing Therapy: A Single-Arm Feasibility Study (Phase 1)
- ClinicalTrials.gov ID
- NCT07897903
- Acronym / sponsor ID
- HEALING-TRAUMA / HT-F1-2026
- Conditions
- Trauma, Psychological, Traumatic Stress Disorder
- Keywords
- Trauma, Traumatic Stress Disorder, Cognitive Processing Therapy, Group Psychotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Grupo ABD
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 27 Oct 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.
Introduction: Post-traumatic stress disorder (PTSD) is a global health challenge requiring effective, evidence-based interventions, such as Cognitive Processing Therapy (CPT). Although clinical guidelines position individual CPT as a first-line treatment, evidence regarding its group format -despite it being the original modality- remains limited. Given the potential of the group format to optimize costs and improve access to treatment in high-demand health systems, evaluating its feasibility and clinical efficacy is a priority.
Objectives: The project proposes a phased research study focused on the implementation, scalability, and clinical impact of group CPT for women who are victims of gender-based violence and exhibit post-traumatic symptoms. Phase 1 (feasibility study) aims to evaluate the acceptability and feasibility of the group CPT protocol.
Methodology: Phase 1 will involve a non-randomized pilot study with female victims of gender-based violence with post-traumatic symptomatology; participants will receive 12 sessions of group CPT. Feasibility will be assessed in this phase based on recruitment rates, adherence, and participant satisfaction. Clinical outcomes (PTSD symptoms, general psychopathology, emotional regulation, and well-being) will be measured at three time points (pre-intervention, post-intervention, and six-month follow-up) using validated instruments.
Expected Results: "Healing Trauma"'s Phase 1 anticipates demonstrating high protocol feasibility and acceptability, as well as a clinically significant reduction in PTSD symptoms and the other measured variables. Furthermore, the project expects to produce a standardized intervention manual that could, in the future, be revised for adaptation and transfer to other psychological care units.
Significance: The project will provide an optimized and scalable group CPT protocol, facilitating the democratization of access to evidence-based treatments -particularly in high-demand health systems- while fostering clinical psychological practice grounded in evidence and scientific rigor.
Detailed description
Background: Seven in ten people will experience a traumatic event in their lifetime; PTSD prevalence among women exposed to gender-based violence is estimated at 30-70%. Guidelines (NICE 2018, APA 2017, WHO 2013) recommend trauma-focused therapies, with CPT as a preferred first-line option. Group CPT could treat up to four times more patients with the same human resources, while simultaneously reducing isolation and normalizing trauma-related cognitions.
Intervention: 12 weekly 90-minute protocolized CPT group (8-10 participants) sessions led by two therapists trained in the protocol. CPT works with postraumatic symptoms through 1) training of cognitive restructuring techniques such as Socratic dialogue and ABC registers, 2) weekly homework and 3) psychoeducation across five themes usually affected after experiencing a traumatic event: safety, trust, power/control, esteem and intimacy. Participants complete one PCL-5 and PHQ-9 register at the start of each session.
Procedure: Grupo ABD therapists refer women in active psychological treatment who show posttraumatic symptoms. A screening session (sociodemographic form, ITEM, PCL-5, PHQ-9) is followed by an individual pre-intervention assessment by the research team (CAPS-5 interview, identification of the index trauma, and ITQ, SA-45, SPWB, SWLS and CERQ). The same battery is repeated post-treatment (plus CSQ) and at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the same 12 weekly CPT group sessions. Assessments will be conducted before, after the intervention and at a 6-months follow-up, with no concurrent comparator group.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Processing Therapy Group Intervention | Experimental | Behavioral: Group CPT + TAU (Experimental)Group Cognitive Processing Therapy. 12 weekly 90-minute sessions, 8-10 participants, 1-2 trained co-therapists, Spanish translation of the Resick, Monson \& Chard (2017) CPT manual; fidelity checklist and group supervision; between-session phone list; individual recap session for missed sessions. Sessions include: psychoeducation and individual worksheets based on cognitive reestructuring techniques |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Exposure to at least one traumatic event (ITEM).
- Active posttraumatic symptoms related to the event (PCL-5 score above cut-off >= 30).
- Women in active psychological treatment at Grupo ABD, referred by their therapist.
Key exclusion criteria (4 listed)
- Active suicidal ideation at screening session (PHQ-9 item 9 and clinical judgment).
- Intellectual disability or severe cognitive impairment.
- Inability to commit to the intervention.
- Concurrent trauma-focused individual or group psychotherapy (e.g., Prolonged Exposure, EMDR, CPT).
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 |
|---|---|---|
| Group CPT + TAU (Experimental)Group Cognitive Processing Therapy. 12 weekly 90-minute sessions, 8-10 participants, 1-2 trained co-therapists, Spanish translation of the Resick CPT manual; fidelity checklist and group supervision; between-session phone list; individual recap session for missed sessions. | Behavioural | Cognitive Processing Therapy Group Intervention |
Primary outcome
Treatment retention/adherence
Time frame: At the beginning of each session (all 12 weeks)
Proportion of enrolled participants who complete the intervention (participants retention/adherance >= 75%).
Recruitment rate
Time frame: Recruitment period
Participants enrolled
Mean number of sessions attended and attrition rate
Time frame: At the beginning of each session (all 12 weeks)
Client Satisfaction Questionnaire
Time frame: Immediately after the intervention (week 12)
Acceptability will be assessed after the intervention using a participant satisfaction questionnaire (CSQ-8). The questionnaire will evaluate participants' perceived usefulness, relevance, comprehensibility, and overall satisfaction with the intervention. 8 items rated from 1 to 4. Total score ranges from 8 to 32. Higher scores indicate greater satisfaction and acceptability (better outcome).
9 secondary outcomes
Change in PTSD/CPTSD symptoms (I) at 12 weeks and 6 months
Time frame: Baseline, at the beginning of each session, end of treatment (week 12), and 6-month follow-up
Change in PTSD/CPTSD symptoms (II) at 12 weeks and 6 months
Time frame: Baseline, end of treatment (week 12), and 6-month follow-up
Change in PTSD/CPTSD symptoms (III) at 12 weeks and 6 months
Time frame: Baseline, end of treatment (week 12), and 6-month follow-up
Change from psychopathological symptoms at 12 weeks and 6 months
Time frame: Baseline, end of treatment (week 12), and 6-month follow-up
Change from Well-being at 12 weeks and 6 months
Time frame: Baseline, end of treatment (week 12), and 6-month follow-up
Change from Satisfaction with life at 12 weeks and 6 months
Time frame: Baseline, end of treatment (week 12), and 6-month follow-up
Change from Emotion Regulation at 12 weeks and 6 months
Time frame: Baseline, end of treatment (week 12), and 6-month follow-up
Change from Self-care at 12 weeks and 6 months
Time frame: Baseline, end of treatment (week 12), and 6-month follow-up
Change from depression at 12 weeks and 6 months
Time frame: Baseline, at the beginning of each session, end of treatment (week 12), and 6-month follow-up
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 27 Oct 2026.
- BackgroundResick, P. A., Monson, C. M., & Chard, K. M. (2024). Cognitive processing therapy for PTSD: A comprehensive therapist manual (2nd ed.). Guilford Press
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Group CPT + TAU (Experimental) in people with Trauma, Psychological and Traumatic Stress Disorder, run by Universidad Complutense de Madrid.
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 4 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Carmen Valiente Ots, PhD (+34913943135, mcvalien@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment retention/adherence (time frame: At the beginning of each session (all 12 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07897903, which also lists 1 linked publication.
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 27 Oct 2026.