A Pilot Study of Feasibility and Acceptability of Videoconference-Delivered Trauma-Focused Cognitive Behavioral Therapy for Treatment of PTSD and C-PTSD in Adults of Community and Hospitals Mental Health Services
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 13
- 试验地点
- 6
- 主要终点
- Eligibility rate as a feasibility indicator
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Trauma-Focused Cognitive Behavioral Therapy for complex presentation (TF-CBT-CP) (Behavioral)
结局指标
主要结局
Eligibility rate as a feasibility indicator
时间窗: At the baseline assessment during the recruitment period.
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.
Recruitment rate as a feasibility indicator.
时间窗: At the baseline assessment during the recruitment period.
The proportion of patients who accept the invitation to participate in the study with respect to those who meet the eligibility criteria.
Participation rate in the evaluation protocol as a feasibility indicator.
时间窗: At baseline, 16-weeks and 20- week after the start of treatment.
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.
Participants attrition rate as a feasibility indicator.
时间窗: When the intervention is finished at 16 weeks after the start of treatment and at follow-up measurement (weeks after the start of treatment).
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.
Trauma-Focused Cognitive Behavioral Therapy for complex presentation (TF-CBT-CP) activities completion rate.
时间窗: During the intervention period.
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.
Participants retention rate as a feasibility indicator.
时间窗: 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).
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.
Participants exit rate as a feasibility indicator.
时间窗: 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).
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.
Qualitative description of the participants' acceptability as an acceptability indicator.
时间窗: At follow-up measurement (20 weeks after the start of treatment).
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.
Reasons for study refusals as an acceptability indicator
时间窗: During the recruitment period.
A list of reasons given by patients who refused to participate in the study. We will aggregate the results as percentages.
Reasons for study drop out as an acceptability indicator
时间窗: During treatment (between week 1 and week 16 after starting treatment) and follow-up (20 weeks after starting treatment)
A list of reasons given by patients who decided to drop-out the study. We will aggregate the results as percentages.
Participant satisfaction as an acceptability indicator
时间窗: 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).
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.
次要结局
- 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.)
- 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.)
- Change in emotion regulation according to mean scores obtained with the Spanish version of the Difficulties in Emotion Regulation Scale (DERS-S).(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.(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.)
- Change in anxiety symptoms according to mean scores obtained with the Generalized Anxiety Disorder Questionnaire (GAD-7).(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.(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 psychological well-being as measured by the Work and Social Adjustment Scale ("WSAS") score.(At baseline, 16 weeks, and 20 weeks after the start of treatment.)
研究者
Andrés Fresno Rodríguez
Profesor Asociado
University of Talca