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

NCT06516874 | Recruiting

• 1 other identifier: FONDECYT REGULAR 1230715
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 5

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.

Conditions

Post Traumatic Stress Disorder; Complex Post-Traumatic Stress Disorder

Keywords

Pilot Study; Feasibility; Acceptability; Trauma-Focused Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (11)

• Eligibility rate as a feasibility indicator

  Proportion of patients who meet eligibility criteria compared to the total number of patients registered in the community mental health care services and hospital referral system during the recruitment period.

  At the baseline assessment during the recruitment period.

• Recruitment rate as a feasibility indicator.

  The proportion of patients who accept the invitation to participate in the study with respect to those who meet the eligibility criteria.

  At the baseline assessment during the recruitment period.

• Participation rate in the evaluation protocol as a feasibility indicator.

  Proportion of patients who fully conclude activities in all 3 assessments: initial evaluation, at week 16 after the start of treatment (or end of treatment), and follow-up at week 20 after the start of treatment, with respect to the total number of people who agree to participate in the study.

  At baseline, 16-weeks and 20- week after the start of treatment.

• Trauma-Focused Cognitive Behavioral Therapy for complex presentation (TF-CBT-CP) activities completion rate.

  Percentage of participants who concluded all (100%) of the proposed activities in the 16 treatment sessions, as reported in the TF-CBT-CP patients' activities diary carried out inside or outside sessions.

  During the intervention period.

• Participants retention rate as a feasibility indicator.

  Percentage of participants who remain in the study at weeks 16 and 20 after the start of treatment, respect to the total number of participants who started treatment.

  When the intervention is finished at 16 weeks after the start of treatment and at follow-up measurement (20 weeks after the start of treatment).

• Participants exit rate as a feasibility indicator.

  Proportion of participants who meet study exit criteria at weeks 16 and 20 after the start of treatment, compared to the total number of participants who started treatment.

  When the intervention is finished at 16-weeks after the start of treatment and at follow-up measurement (20 weeks after the start of treatment).

• Participants attrition rate as a feasibility indicator.

  Proportion of participants who drop out of the study at weeks 16 and 20 after the start of treatment, compared to the total number of participants who started treatment.

  When the intervention is finished at 16 weeks after the start of treatment and at follow-up measurement (weeks after the start of treatment).

• Qualitative description of the participants' acceptability as an acceptability indicator.

  To obtain a qualitative description of participants' acceptability of the recruitment process, the assessment protocol (baseline, end-of-treatment, and follow-up assessment), and the treatment, semi-structured interviews will be conducted with participants, including questions related to acceptability of the study. The information collected will be recorded and summarized using thematic analysis guidelines.

  At follow-up measurement (20 weeks after the start of treatment).

• Reasons for study refusals as an acceptability indicator

  A list of reasons given by patients who refused to participate in the study. We will aggregate the results as percentages.

  During the recruitment period.

• Reasons for study drop out as an acceptability indicator

  A list of reasons given by patients who decided to drop-out the study. We will aggregate the results as percentages.

  During treatment (between week 1 and week 16 after starting treatment) and follow-up (20 weeks after starting treatment)

• Participant satisfaction as an acceptability indicator

  Description of participant satisfaction level based on the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is a self-report scale of 8 items that evaluate patients' overall satisfaction with treatment through a Likert scale from 1 (low satisfaction) to 4 (high satisfaction); the higher the score, the higher the patients' satisfaction.

  When the intervention is finished at 16 weeks after the start of treatment and at follow-up measurement (20 weeks after the start of treatment).

Secondary Outcomes (10)

• Changes in PTSD symptoms, according to mean scores obtained with the International Trauma Questionnaire (ITQ).

  At baseline, 16 weeks, and 20 weeks after the start of treatment.

• Changes in CPTSD symptoms, according to mean scores obtained with the International Trauma Questionnaire (ITQ).

  At baseline, 16 weeks, and 20 weeks after the start of treatment.

• Changes in PTSD symptoms, according to mean scores obtained with the International Trauma Interview (ITI).

  At baseline, 16 weeks, and 20 weeks after the start of treatment.

• Changes in CPTSD symptoms, according to mean scores obtained with the International Trauma Interview (ITI).

  At baseline, 16 weeks, and 20 weeks after the start of treatment.

• Change in depressive symptoms according to mean scores obtained with the Patient Health Questionnaire (PHQ-9).

  At baseline, 16 weeks, and 20 weeks after the start of treatment.

Study Arms (1)

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

EXPERIMENTAL

The TF-CBT-CP includes: a) conducting clinical assessment sessions; b) providing psychoeducation on PTSD and CPTSD; c) facilitating the development of coping strategies to manage distressing experiences; d) implementing behavioral activation techniques to reintegrate into daily activities; e) fostering the acquisition of emotional regulation strategies and interpersonal relationship skills; f) utilizing in-vivo (live) and imaginal exposure methods to confront the traumatic memory; g) cognitive work to cope with distorted thoughts, and h) relapse prevention.

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

Interventions

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

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

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

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Talca: lead
• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile: collaborator
• Universidad del Desarrollo: collaborator
• Universidad Católica del Maule: collaborator
• Servicio de Salud del Maule, Chile: collaborator

Study Sites (5)

Centro Comunitario de Salud Mental de Curicó (COSAM)

Curicó, Maule Region, 3340000, Chile

RECRUITING

Centro Comunitario de Salud Mental de Linares (COSAM)

Linares, Maule Region, 3580000, Chile

RECRUITING

Hospital de Linares

Linares, Maule Region, 3580000, Chile

RECRUITING

Centro Comunitario de Salud Mental de Maule (COSAM)

Maule, Maule Region, 3460000, Chile

RECRUITING

Centro Comunitario de Salud Mental de Talca (COSAM)

Talca, Maule Region, 3460000, Chile

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Andrés Fresno Rodríguez

  University of Talca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrés Fresno Rodríguez

CONTACT

+56 71 220 1784; afresno@utalca.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor Asociado

Model Details: This study is a superiority pilot/feasibility study.

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 24, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (5)