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

University of Talca

Status: Enrolling

Conditions: Post Traumatic Stress Disorder; Complex Post-Traumatic Stress Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06516874

FONDECYT REGULAR 1230715

Details and patient eligibility

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.

Full 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.

Enrollment: 13 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility 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 the complex form of Post-Traumatic Stress Disorder (CPTSD).
• Not being treated for PTSD or C-PTSD at the time of recruitment

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

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