A Pilot Clinical Trial of Trauma-Focused Cognitive-Behavioral Therapy for Treatment of Post-traumatic Stress in Adults.
NCT Number: NCT06516874
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Traumatic Stress Disorder|Complex Post-Traumatic Stress Disorder
Interventions: BEHAVIORAL: Trauma-Focused Cognitive Behavioral Therapy for complex presentation (TF-CBT-CP)|OTHER: TAU
Sponsor: University of Talca
Collaborators: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile|Servicio de Salud del Maule, Chile|Universidad del Desarrollo|Universidad Católica del Maule
Sex: ALL
Age: ADULT
Enrollment: 68
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2026-03-31
Locations: Centro Comunitario de Salud Mental de Talca (COSAM), Talca, Región Del Maule, 3460000, Chile

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.

Primary Outcome Measures: 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' 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 Experimental Group 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 Experimental Group 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 evaluates 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 Outcome Measures: Changes in PTSD symptoms, according to mean scores obtained with the International Trauma Questionnaire (ITQ)., The ITQ (International Trauma Questionnaire) is an 18-item self-report scale that assesses PTSD and complex PTSD (CPTSD) symptomatology based on the International Classification of Diseases 11 (ICD-11) and functional impairment. Each item is scored on a Likert scale ranging from 0 (not at all) to 4 points (extremely); the higher the score, the greater the symptomatology., 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)., The ITQ (International Trauma Questionnaire) is an 18-item self-report scale that assesses PTSD and complex PTSD (CPTSD) symptomatology based on the International Classification of Diseases 11 (ICD-11) and functional impairment. Each item is scored on a Likert scale ranging from 0 (not at all) to 4 points (extremely); the higher the score, the greater the symptomatology., 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)., The ITI (International Trauma Interview) is a 16-item semi-structured interview that allows for determining the diagnosis of PTSD and CPTSD by assessing PTSD symptoms and Disturbances in Self-Organization symptoms. The interview takes between 45 and 60 minutes., 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)., The ITI (International Trauma Interview) is a 16-item semi-structured interview that allows for determining the diagnosis of PTSD and CPTSD by assessing PTSD symptoms and Disturbances in Self-Organization symptoms. The interview takes between 45 and 60 minutes., 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)., The PHQ-9 is a 9-item self-report scale assessing the frequency of depressive symptoms in the past 2 weeks. Its response scale is 0 = "never," 1 = "some days," 2 = "more than half of the days," and 3 = "almost every day." The higher the score, the greater the symptomatology. This scale has been translated and validated for the Chilean population., At baseline, 16 weeks, and 20 weeks after the start of treatment.|Change in anxiety symptoms according to mean scores obtained with the Generalized Anxiety Disorder Questionnaire (GAD-7)., The GAD-7 is a 7-item self-report scale assessing the frequency of anxious symptoms during the past 2 weeks. Its response scale is 0 = "not at all," 1 = "several days," 2 = "more than half of the days," and 3 = "nearly every day." The higher the score, the greater the symptomatology., At baseline, 16 weeks, and 20 weeks after the start of treatment.|Change in emotion regulation according to mean scores obtained with the Spanish version of the Difficulties in Emotion Regulation Scale (DERS-S)., The DERS-S is a 25-item self-report scale that assesses emotional regulation problems. Its Likert-type response scale ranges from 1 (almost never) to 5 (almost always). The lower the score, the better emotion regulation., At baseline, 16 weeks, and 20 weeks after the start of treatment.|Change in psychological well-being as measured by the Work and Social Adjustment Scale ("WSAS") score., The WSAS is a 5-item self-report scale that assesses impairment in functioning, considering the impact of a person's mental health difficulties on their ability to function in terms of work, home management, social leisure, private leisure, and personal or family relationships. The higher the score, the greater the functional impairment., At baseline, 16 weeks, and 20 weeks after the start of treatment.|Change in psychological well-being as measured by the Clinical Outcomes in Routine Evaluation (CORE-10) score., The CORE-10 is a self-reported 10-item measure for common presentations of psychological distress. The higher the score, the higher the psychological distress., At baseline, 16 weeks, and 20 weeks after the start of treatment.|Change in psychological well-being as measured by the International Trauma Questionnaire (ITQ) impairment items., International Trauma Questionnaire (ITQ) items associated with impairment in important areas of functioning refer to items that assess impairment in the person's functioning associated with PTSD symptoms or DSO symptoms., At baseline, 16 weeks, and 20 weeks after the start of treatment.