An interventional study of Group CPT + TAU (Experimental) in Trauma, Psychological and Traumatic Stress Disorder, sponsored by Universidad Complutense de Madrid. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
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.
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.
144 studies on the registry are indexed under Psychological Trauma; 41 are open to participants now.
This study's planned enrollment of 10 is below the median of 80 across 109 interventional studies indexed under Psychological Trauma.
Browse Psychological Trauma studies →Universidad Complutense de Madrid is the lead sponsor of 206 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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 CPT manual; fidelity checklist and group supervision; between-session phone list; individual recap session for missed sessions.
Treatment retention/adherence
Proportion of enrolled participants who complete the intervention (participants retention/adherance \>= 75%).
Time frame: At the beginning of each session (all 12 weeks)
Recruitment rate
Participants enrolled
Time frame: Recruitment period
Mean number of sessions attended and attrition rate
Time frame: 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).
Time frame: Immediately after the intervention (week 12)
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).
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
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).
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
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline, at the beginning of each session, end of treatment (week 12), and 6-month follow-up
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad Complutense de Madrid →