NCT06516874 A Pilot Study of Trauma-Focused Cognitive-Behavioral Therapy for Treatment of Post-traumatic Stress in Adults.
| NCT ID | NCT06516874 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Talca |
| Condition | Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 13 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 13 participants in total. It began in 2024-10-22 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Post-traumatic stress disorder (PTSD) is a mental health condition that's triggered by the experience of potentially traumatic events. Complex PTSD (CPTSD) includes additional symptoms that account for a disturbance of the organization of the self. Randomized controlled trials have shown that trauma-focused cognitive behavioral therapy (TF-CBT) is effective in reducing PTSD symptoms; however, there is insufficient evidence to support the effectiveness of this intervention for CPTSD. The present study aims to evaluate the feasibility and acceptability of TF-CBT therapy for complex presentation (TF-CBT-CP) in a videoconference modality in adults diagnosed with PTSD or CPTSD who are treated at community mental health care services (CMHCS, COSAM in Spanish) and the Hospital of the Maule Region, Chile. This pilot study will use a mixed design. The quantitative component will consist of a one-group pre-post-follow-up design, which will include 13 adults diagnosed with PTSD or CPTSD referred to care at CMHCS or hospitals of the Maule Region, Chile. Telephone interviews will collect qualitative data relevant to the study's acceptability. Participants will receive TF-CBT-CP therapy. It consists of 16 weekly 60-minute sessions of trauma-focused cognitive behavioral therapy for complex presentations. To determine the feasibility of TF-CBT-CP therapy, eligibility, recruitment, participation, activity completion, retention, exit, and dropout rates will be considered. To establish the acceptability of the protocol, participant satisfaction with the recruitment, assessment, and treatment process and reporting of reasons for non-participation or dropout will be assessed. Furthermore, secondary outcomes consider the reduction of PTSD and CPTSD symptomatology, depression, and anxiety and the improvement of indicators of emotional regulation and psychological well-being.
Eligibility Criteria
Eligibility criteria: * Men and women over 18 years of age. * Referred to a community mental health care service (CMHCS) or hospital in the Maule Region for difficulties associated with the experience of traumatic events, symptomatology, or diagnosis of Post-Traumatic Stress Disorder (PTSD) or the complex form of Post-Traumatic Stress Disorder (CPTSD). * Not being treated for PTSD or C-PTSD at the time of recruitment Inclusion Criteria: * Men and women over 18 years of age. * Referred to a community mental health care service (CMHCS) or hospital in the Maule Region for difficulties associated with the experience of traumatic events, symptomatology, or diagnosis of Post-Traumatic Stress Disorder (PTSD) or Complex Post-Traumatic Stress Disorder (CPTSD). * Having the diagnosis of Post-Traumatic Stress Disorder (PTSD) or Complex Post-Traumatic Stress Disorder (CPTSD) by International Trauma Interview (ITI). * Fluent in oral and written Spanish language. * Access to telephone. Exclusion Criteria: * Previously or currently diagnosed psychotic disorder. * Current substance use disorder. * Current suicidal crisis. * Depression is the primary diagnosis. * Participation in a PTSD psychological treatment parallel to the study. Study's exit criteria: * Initiation of a psychological or pharmacological treatment for PTSD parallel to the study. * Change of medication dose in the case of participants with pharmacological treatment prior to the study.
Contact & Investigator
Andrés Fresno Rodríguez
PRINCIPAL INVESTIGATOR
University of Talca
Frequently Asked Questions
Who can join the NCT06516874 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06516874 currently recruiting?
Yes, NCT06516874 is actively recruiting participants. Contact the research team at afresno@utalca.cl for enrollment information.
Where is the NCT06516874 trial being conducted?
This trial is being conducted at Curicó, Chile, Linares, Chile, Linares, Chile, Maule, Chile and 1 additional location.
Who is sponsoring the NCT06516874 clinical trial?
NCT06516874 is sponsored by University of Talca. The principal investigator is Andrés Fresno Rodríguez at University of Talca. The trial plans to enroll 13 participants.