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

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.

Conditions

• Post Traumatic Stress Disorder
• Complex Post-Traumatic Stress Disorder

Interventions

BEHAVIORAL

Trauma-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.

Sponsors & Collaborators

• Servicio de Salud del Maule, Chile

  collaborator UNKNOWN

• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

  collaborator OTHER_GOV

• Universidad del Desarrollo

  collaborator OTHER

• Universidad Católica del Maule

  collaborator OTHER

• University of Talca

  lead OTHER

Principal Investigators

• Andrés Fresno Rodríguez · University of Talca

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-22

Primary Completion

2027-02-28

Completion

2027-03-31

Countries

• Chile

Study Locations