RecruitingNot ApplicableNCT06516874

A Pilot Study of Trauma-Focused Cognitive-Behavioral Therapy for Treatment of Post-traumatic Stress in Adults.

A Pilot Study of Feasibility and Acceptability of Videoconference-Delivered Trauma-Focused Cognitive Behavioral Therapy for Treatment of PTSD and C-PTSD in Adults of Community and Hospitals Mental Health Services


Sponsor

University of Talca

Enrollment

13 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing a psychological therapy called Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) in adults living with post-traumatic stress disorder (PTSD) or complex PTSD (C-PTSD) — conditions that can develop after experiencing deeply distressing events. The study is being conducted in the Maule region of Chile. **You may be eligible if...** - You are 18 or older (any gender) - You have been referred to a mental health service or hospital in the Maule Region because of trauma-related symptoms, PTSD, or complex PTSD - You are not currently receiving another active PTSD treatment **You may NOT be eligible if...** - You are already undergoing a different treatment specifically for PTSD or C-PTSD at the time of recruitment - You do not meet the study's clinical criteria for trauma-related conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALTrauma-Focused Cognitive Behavioral Therapy for complex presentation (TF-CBT-CP)

This TF-CBT-CP is a short-term intervention to treat outpatients. This will be carried out via videoconference.


Locations(5)

Centro Comunitario de Salud Mental de Curicó (COSAM)

Curicó, Maule Region, Chile

Centro Comunitario de Salud Mental de Linares (COSAM)

Linares, Maule Region, Chile

Hospital de Linares

Linares, Maule Region, Chile

Centro Comunitario de Salud Mental de Maule (COSAM)

Maule, Maule Region, Chile

Centro Comunitario de Salud Mental de Talca (COSAM)

Talca, Maule Region, Chile

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NCT06516874


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