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

NCT ID: NCT06516874

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-22
• Study Completion Date: 2026-03-31

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.

Detailed Description

Post-traumatic stress disorder (PTSD) is a mental health condition that's triggered by the experience of potentially traumatic events. It is a disabling psychopathology with high comorbidity, associated with problems of emotional regulation and low psychological well-being. In addition, the World Health Organization (WHO) has recently proposed the diagnosis of complex PTSD (CPTSD) to account for a type of PTSD that includes both traditional and additional symptoms that account for a disturbance of self-organization of the self.

Randomized controlled trials (RCT) have shown that trauma-focused cognitive behavioral therapy (TF-CBT) is effective in reducing PTSD symptoms. However, additional clinical studies are necessary to fully assess the effectiveness of TF-CBT for complex presentations (TF-CBT-CP). Additionally, adapting PTSD therapy to a new population requires prior knowledge of information that may affect the effects of the intervention, e.g., history of traumatic events, variety and intensity of PTSD symptoms, and comorbidities. Given the lack of knowledge of these characteristics in Chile and for the purpose of subsequently implementing a large-scale randomized clinical trial in the Chilean population, the CONSORT guidelines recommend developing a pilot RCT.

The present study aims to evaluate the feasibility and acceptability of TF-CBT-CP therapy in a videoconference modality in adults diagnosed with PTSD or CPTSD who are treated at community mental health care services (CMHCS) or hospitals in 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. Participants will receive-by videoconference-TF-CBT-CP therapy, which consists of 16 weekly 60-minute sessions of trauma-focused cognitive behavioral therapy for complex presentations.

The treatment 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) engaging in cognitive interventions to address distorted thoughts; and h) implementing relapse prevention strategies. Clinical psychologists, trained by the research team, will implement the treatment. To ensure the fidelity of the TF-CBT-CP treatment, the project team will conduct weekly supervisions and review compliance with the activities of each session using a checklist based on the therapy protocol. The project team will provide supervision.

Professionals designated by CMHCS or hospitals will present the study to eligible individuals and ask if they are willing to be contacted by the study's research assistant(s) via telephone as part of the initial recruitment process. The research assistants will explain the study characteristics and the selection process, paying particular attention to the study inclusion and exclusion criteria. If the person agrees to participate, he or she will be invited to an in-person interview at the respective health services to address any doubts about the study and to complete the informed consent process.

Those who have agreed to participate and signed the informed consent form do the initial evaluation. This initial assessment will be conducted via videoconference, where trained psychologists will administer the Life Event Checklist-5 (LEC-5) and the International Trauma Questionnaire (ITQ), a self-report questionnaire that assesses PTSD and CPTSD symptoms. Trained psychologists administer the Mini-International Neuropsychiatric Interview (MINI) to determine whether individuals at risk for PTSD or CPTSD on previous instruments meet exclusion criteria. If the person is at risk of PTSD or CPTSD and does not meet any exclusion criteria, trained psychologists administer additional questionnaires to assess depressive (Patient Health Questionnaire, PHQ-9) and anxious symptoms (Generalized Anxiety Disorder Questionnaire, GAD-7), suicidal ideation and behavior (Columbia-Suicide Severity Rating Scale, C-SSRS), alcohol consumption and/or dependence (Alcohol and Other Drugs Use Questionnaire, AUDIT), emotional regulation problems (Spanish version of Difficulties in Emotion Regulation Scale, DERS-S), and impaired functioning (Work and Social Adjustment Scale, WSAS, and Clinical Outcomes in Routine Evaluation, CORE-10). In addition, another evaluation session is scheduled, where the diagnosis of PTSD or CPTSD is established through the International Trauma Interview (ITI). Participants who are excluded during this evaluation process will be invited to a feedback interview via videoconference.

Participants who meet the inclusion criteria and do not present exclusion criteria will engage in 16 weekly 60-minute sessions of trauma-focused cognitive behavioral therapy (TF-CBT-CP) through videoconference.

Participants will be invited to an evaluation session via video conference at the end of week 16 (final measurement) and week 20 (follow-up) after the start of treatment. During this session, they will participate in the International Trauma Interview (ITI) and complete the following questionnaires: ITQ, PHQ-9, GAD-7, C-SSRS, AUDIT, DERS-S, WSAS, and CORE-10. Furthermore, the participants' satisfaction with the intervention will be assessed using the Client Satisfaction Questionnaire (CSQ-8) at each of these measurement points.

To guarantee access to a computer with connectivity for video conferencing and a confidential space for TF-CBT-CP therapy, both the evaluation and treatment sessions will take place in the respective health services' room or in a similar clinical care center, where a notebook, internet connection, printer, camera, and microphone will be available to be used by study participants.

Trained psychologists will collect qualitative data related to the study's acceptability through telephone interviews after the follow-up measurement. They will apply an open-ended interview to all participants. Data collection will continue until the saturation point is reached. The thematic analysis will be done on the transcribed interviews.

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 and dropout will be assessed. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

OTHER_GOV

Sponsor Role: collaborator

Universidad del Desarrollo

OTHER

Sponsor Role: collaborator

Universidad Católica del Maule

OTHER

Sponsor Role: collaborator

Servicio de Salud del Maule, Chile

UNKNOWN

Sponsor Role: collaborator

University of Talca

OTHER

Sponsor Role: lead

Responsible Party

Andrés Fresno Rodríguez

Profesor Asociado

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrés Fresno Rodríguez

Role: PRINCIPAL_INVESTIGATOR

University of Talca

Locations

Centro Comunitario de Salud Mental de Curicó (COSAM)

Curicó, Maule Region, Chile

Site Status: RECRUITING

Centro Comunitario de Salud Mental de Linares (COSAM)

Linares, Maule Region, Chile

Site Status: RECRUITING

Hospital de Linares

Linares, Maule Region, Chile

Site Status: RECRUITING

Centro Comunitario de Salud Mental de Maule (COSAM)

Maule, Maule Region, Chile

Site Status: RECRUITING

Centro Comunitario de Salud Mental de Talca (COSAM)

Talca, Maule Region, Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Andrés Fresno Rodríguez

Role: CONTACT

Phone: +56 71 220 1784

Email: afresno@utalca.cl

Facility Contacts

Leandro Gómez

Role: primary

Role: backup

María Carolina Rodríguez

Role: primary

Role: backup

Pamela Díaz

Role: primary

Role: backup

Víctor Valdez

Role: primary

Role: backup

Ruth Castillo

Role: primary

Other Identifiers

FONDECYT REGULAR 1230715

Identifier Type: -

Identifier Source: org_study_id