Clinical trial NCT06516874: A Pilot Clinical Trial of Trauma-Focused Cognitive-Behavioral Therapy for Treatment of Post-traumatic Stress in Adults.
Official title: A Pilot Clinical Trial of Feasibility, Acceptability, and Preliminary Effectiveness of Videoconference-Delivered Trauma-Focused Cognitive Behavioral Therapy for Treatment of PTSD and C-PTSD in Adults of Community Mental Health Services
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Complex Post-Traumatic Stress Disorder
Keywords: Pilot Randomized Clinical Trial
Feasibility
Acceptability
Trauma-Focused Cognitive Behavioral Therapy
Preliminary Effectiveness
Lead sponsor: University of Talca
Sponsor class: OTHER
Collaborators: name: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
name: Universidad del Desarrollo
name: Universidad Católica del Maule
name: Servicio de Salud del Maule, Chile
First posted: 2024-07-24
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a superiority pilot/feasibility study. Participants will be randomized to intervention or control group
Primary purpose: TREATMENT

Brief summary: Post-traumatic stress disorder (PTSD) is a mental health condition that's triggered by the experience of potentially traumatic events. A 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, acceptability, and preliminary effectiveness of TF-CBT therapy for complex presentation (TF-CBT-CP) in videoconference modality compared with the usual treatment for the reduction of PTSD and CPTSD symptoms in adults diagnosed with PTSD or CPTSD, who are treated at the community mental health care services (CMHCS, COSAM in spanish) of the Maule Region, Chile.

This pilot study will use a mixed design. The quantitative component will consist of a randomized two-arm parallel superiority trial, blinded to the data analyst, which will include 68 adults diagnosed with PTSD or CPTSD referred to care at CMHCS of the Maule Region, Chile. The collection of qualitative data related to the study's acceptability will be done through telephone interviews.

Participants will be randomized into experimental (EG) or control (CG) groups in a 1:1 ratio. Participants in the EG will receive TF-CBT-CP therapy. It consists of 16 weekly 60-minute sessions of trauma-focused cognitive behavioral therapy for complex presentations. People who take part in the CG will get the same treatment (TAU) that CMHCS gives to people who are referred for PTSD symptoms or problems related to traumatic events. This could mean waiting on a list, getting medication, and/or going to regular non-specialized PTSD therapy sessions.

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. Secondary outcomes of preliminary effectiveness consider the reduction of PTSD and CPTSD symptomatology, depression, anxiety, and 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 presentation (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.

Thus, the present study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of TF-CBT-CP therapy in videoconference modality compared with the usual treatment on the reduction of PTSD and CPTSD symptoms in adults diagnosed with PTSD or CPTSD, who are treated at the community mental health care services (CMHCS) of the Maule Region, Chile.

This pilot study will use a mixed design. The quantitative component will consist of carrying out a randomized two-arm parallel superiority trial, blinded to the data analyst. The study's sample will include 68 persons who have been diagnosed with either PTSD or CPTSD and referred to care at community mental health care services (CMHCS) in the Maule Region, Chile.

The investigators will randomly assign participants to the experimental (EG) or control (CG) groups in a 1:1 ratio. Participants in the EG will receive 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. Two clinical psychologists, trained by the research team, will apply 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. The CG will receive the usual care (TAU) provided by CMHCS for individuals referred for PTSD symptoms or trauma-related issues. This could include waiting on a list, getting medication, and/or going to regular non-specialized PTSD therapy sessions. CMHCS professionals will provide this treatment.

CMHCS' intake professionals 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 o she will be invited to an in-person interview at CMHCS or at a similar clinical care center 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 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.

The EG participants will engage in 16 weekly 60-minute sessions of trauma-focused cognitive behavioral therapy (TF-CBT-CP) throughout videoconference. CG participants will receive the usual care offered by their respective CMHCS. Participants from both groups 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 CMHCS' 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 psychologist will collect qualitative data related to the study's acceptability through telephone interviews after the follow-up measurement in both groups. Trained psychologist will apply an open-ended interview to a randomly select an initial sample of six participants (3 in each group). Data collection will continue until 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 of preliminary effectiveness consider the reduction of PTSD and CPTSD symptomatology, depression and anxiety, and improvement of indicators of emotional regulation and psychological well-being. The investigators expect the TF-CBT-CP treatment in the videoconferencing modality to decrease symptoms of PTSD, CPTSD, depression, and anxiety and improve indicators of emotional regulation and psychological well-being at 16 and 20 weeks after the start of treatment. The investigators expect this effect to be greater in the EG than in the CG.

Eligibility criteria: Eligibility criteria:

* Men and women over 18 years of age.
* Referred to a community mental health care service (CMHCS) 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).

Inclusion Criteria:

* Men and women over 18 years of age.
* Referred to a community mental health care service (CMHCS) 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 psychological treatment parallel to the clinical trial.

Study's exit criteria:

* Initiation of a psychological or pharmacological parallel treatment during the study.
* Change of medication dose in the case of participants with pharmacological treatment prior to the study.

Primary outcomes:
measure: Eligibility rate as a feasibility indicator
timeFrame: At the baseline assessment during the recruitment period.
measure: Recruitment rate as a feasibility indicator.
timeFrame: At the baseline assessment during the recruitment period.
measure: Participation rate in the evaluation protocol as a feasibility indicator.
timeFrame: At baseline, 16-weeks and 20- week after the start of treatment.
measure: Trauma-Focused Cognitive Behavioral Therapy for complex presentation (TF-CBT-CP) activities completion rate.
timeFrame: During the intervention period.
measure: Participants retention rate as a feasibility indicator.
timeFrame: 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).
measure: Participants exit rate as a feasibility indicator.
timeFrame: 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).
measure: Participants attrition rate as a feasibility indicator.
timeFrame: When the intervention is finished at 16 weeks after the start of treatment and at follow-up measurement (weeks after the start of treatment).
measure: Qualitative description of the participants' acceptability as an acceptability indicator.
timeFrame: At follow-up measurement (20 weeks after the start of treatment).
measure: Reasons for study refusals as an acceptability indicator
timeFrame: During the recruitment period.
measure: Reasons for study drop out as an acceptability indicator
timeFrame: During treatment (between week 1 and week 16 after starting treatment) and follow-up (20 weeks after starting treatment)
measure: Participant satisfaction as an acceptability indicator
timeFrame: 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:
measure: Changes in PTSD symptoms, according to mean scores obtained with the International Trauma Questionnaire (ITQ).
timeFrame: At baseline, 16 weeks, and 20 weeks after the start of treatment.
measure: Changes in CPTSD symptoms, according to mean scores obtained with the International Trauma Questionnaire (ITQ).
timeFrame: At baseline, 16 weeks, and 20 weeks after the start of treatment.
measure: Changes in PTSD symptoms, according to mean scores obtained with the International Trauma Interview (ITI).
timeFrame: At baseline, 16 weeks, and 20 weeks after the start of treatment.
measure: Changes in CPTSD symptoms, according to mean scores obtained with the International Trauma Interview (ITI).
timeFrame: At baseline, 16 weeks, and 20 weeks after the start of treatment.
measure: Change in depressive symptoms according to mean scores obtained with the Patient Health Questionnaire (PHQ-9).
timeFrame: At baseline, 16 weeks, and 20 weeks after the start of treatment.
measure: Change in anxiety symptoms according to mean scores obtained with the Generalized Anxiety Disorder Questionnaire (GAD-7).
timeFrame: At baseline, 16 weeks, and 20 weeks after the start of treatment.
measure: Change in emotion regulation according to mean scores obtained with the Spanish version of the Difficulties in Emotion Regulation Scale (DERS-S).
timeFrame: At baseline, 16 weeks, and 20 weeks after the start of treatment.
measure: Change in psychological well-being as measured by the Work and Social Adjustment Scale ("WSAS") score.
timeFrame: At baseline, 16 weeks, and 20 weeks after the start of treatment.
measure: Change in psychological well-being as measured by the Clinical Outcomes in Routine Evaluation (CORE-10) score.
timeFrame: At baseline, 16 weeks, and 20 weeks after the start of treatment.
measure: Change in psychological well-being as measured by the International Trauma Questionnaire (ITQ) impairment items.
timeFrame: At baseline, 16 weeks, and 20 weeks after the start of treatment.
Other outcomes:
Locations:
city: Talca
country: Chile
facility: Centro Comunitario de Salud Mental de Talca (COSAM)
state: Región del Maule
Study officials:
affiliation: University of Talca
name: Andrés Fresno Rodríguez
role: PRINCIPAL_INVESTIGATOR
References: