Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
NCT06516874

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

Led by University of Talca · Updated on 2026-02-03

13

Participants Needed

5

Research Sites

127 weeks

Total Duration

On this page

Sponsors

U

University of Talca

Lead Sponsor

F

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women over 18 years of age
  • Referred to a community mental health care service or hospital in the Maule Region for difficulties related to traumatic events, symptoms, or diagnosis of PTSD or CPTSD
  • Diagnosis of PTSD or CPTSD confirmed by International Trauma Interview (ITI)
  • Fluent in spoken and written Spanish
  • Access to a telephone
Not Eligible

You will not qualify if you...

  • Previously or currently diagnosed psychotic disorder
  • Current substance use disorder
  • Current suicidal crisis
  • Depression as the primary diagnosis
  • Receiving psychological treatment for PTSD parallel to the study
  • Starting psychological or pharmacological treatment for PTSD during the study
  • Changes in medication dose if on pharmacological treatment before study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Centro Comunitario de Salud Mental de Curicó (COSAM)

Curicó, Maule Region, Chile, 3340000

Actively Recruiting

2

Centro Comunitario de Salud Mental de Linares (COSAM)

Linares, Maule Region, Chile, 3580000

Actively Recruiting

3

Hospital de Linares

Linares, Maule Region, Chile, 3580000

Actively Recruiting

4

Centro Comunitario de Salud Mental de Maule (COSAM)

Maule, Maule Region, Chile, 3460000

Actively Recruiting

5

Centro Comunitario de Salud Mental de Talca (COSAM)

Talca, Maule Region, Chile, 3460000

Actively Recruiting

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Research Team

A

Andrés Fresno Rodríguez

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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