Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
ID06516874

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

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

13

Participants Needed

5

Research Sites

4 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

Researchers are studying post-traumatic stress disorder (PTSD) and complex PTSD (CPTSD), which includes additional symptoms affecting self-organization. This study evaluates the feasibility and acceptability of trauma-focused cognitive behavioral therapy for complex presentations (TF-CBT-CP) delivered via videoconference to adults diagnosed with PTSD or CPTSD in community mental health services and hospitals in the Maule Region, Chile. The study is a pilot with a mixed design involving 13 adults to prepare for a larger trial in this population. Participants will receive TF-CBT-CP therapy consisting of 16 weekly 60-minute sessions delivered by trained clinical psychologists using videoconference. The therapy includes assessment, psychoeducation, coping strategy development, behavioral activation, emotional regulation and interpersonal skills, exposure to traumatic memories, cognitive interventions, and relapse prevention. Sessions and assessments will take place in clinical settings equipped with the necessary technology to ensure privacy and connectivity. Participants will undergo initial and follow-up evaluations via videoconference using clinical interviews and questionnaires assessing PTSD, CPTSD, depression, anxiety, suicidal ideation, substance use, emotional regulation, and functioning. Satisfaction with the intervention and reasons for dropout will be monitored. Feasibility outcomes include recruitment, retention, and treatment completion rates, while secondary outcomes focus on symptom reduction and psychological well-being improvements. Qualitative interviews will explore participant acceptability after treatment completion, with total participation lasting about 20 weeks.

CONDITIONS

Brief 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, PTSD, or Complex PTSD
  • Diagnosis of PTSD or Complex PTSD confirmed by International Trauma Interview
  • 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 during the study
  • Initiation of new PTSD psychological or pharmacological treatment during the study
  • Change in medication dose if already on pharmacological treatment before the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) to complete informed consent and initial eligibility assessment

Outpatient Treatment

Duration - 16 weeks

Participants receive Trauma-Focused Cognitive Behavioral Therapy for complex presentation (TF-CBT-CP) via videoconference consisting of 16 weekly 60-minute sessions.

16 weekly sessions via videoconference

Follow-up

Duration - 4 weeks

Participants complete evaluation sessions to assess treatment outcomes and satisfaction 4 weeks after treatment ends.

1 videoconference evaluation session at week 20

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

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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