(Cost)-Effectiveness of Intensive Trauma-Focused Treatment Versus Spaced Trauma-Focused Treatment As First Line Treatment for Post-Traumatic Stress Disorder in Adults with Multiple Trauma Exposure: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 186
- 试验地点
- 8
- 主要终点
- Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
研究概览
简要总结
The goal of this clinical trial is to learn if an intensive program can treat post-traumatic stress disorder (PTSD) in adults getting treatment for the first time, and whether it has lower societal costs. The main questions it aims to answer are:
- Does an intensive program reduce PTSD symptoms?
- How expensive is it on a societal level? Researchers will compare the intensive program to the standard weekly treatment to see if the intensive program works to treat PTSD.
Participants will:
- Get 5 days of intensive treatment in two weeks (with two preparatory and closing sessions), or weekly sessions
- Get questionnaires and interviews 5 times in 9 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
For the clinical interviews (CAPS-5, MINI-S, VLGT), the trained assessors will be blind to condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •PTSD diagnosis according to DSM-5 (CAPS-5);
- •PTSD diagnosis stemming from 2 or more potentially traumatic events (PTEs)
- •seeking first-time treatment for PTSD (or less than 8 sessions);
- •employed (working or on sick leave for less than two years)
排除标准
- •Current psychotic disorder, severe alcohol or substance use disorder, high suicidal intent (MINI-S for DSM-5) and a concrete suicide plan, or severe aggressive behavior that poses danger for others
- •insufficient command of the Dutch language to be able to complete the assessments. This will be determined through clinical judgment at intake.
结局指标
主要结局
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
时间窗: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
The primary outcome, severity of Post-Traumatic Stress Disorder (PTSD) is assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). CAPS-5 is a comprehensive 20-item clinical interview that assesses both the DSM-5 PTSD diagnostic criteria and the severity of PTSD symptoms. Scores range from 0 to 80, with higher scores denoting greater symptom severity. The CAPS-5 showed high internal consistency and interrater reliability, good test-retest reliability, and good validity. All the assessors are or will be trained to administer the Dutch versions of the CAPS-5. It requires a total of 225 minutes to complete at all measurement points.
Cost-effectiveness (Quality of life)
时间窗: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Cost-effectiveness is a composite measure of quality of life (physical and mental), and treatment inventory of costs. Quality of life will be assessed using the Euro Quality of Life 5 Dimensions (EQ-5D-5L) scale. This scale comprises 14 items categorized into various aspects of health status, rated on a three-point scale.
Cost-effectiveness (Mental Health Quality of Life Questionnaire)
时间窗: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Cost-effectiveness is a composite measure of quality of life (physical and mental), and treatment inventory of costs. The Mental Health Quality of Life Questionnaire (MHQoL) will be utilized to assess the quality of life among individuals with mental health issues. The MHQoL comprises a descriptive system (the MHQoL-7D) and a visual analog scale (MHQoL-VAS).
Cost-effectiveness (Treatment inventory of costs)
时间窗: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Cost-effectiveness is a composite measure of quality of life (physical and mental), and treatment inventory of costs. The Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P) will be utilized to map the costs arising from psychosocial problems in adults. It consists of three components: general questions, questions regarding medical care utilization, and questions related to work.
次要结局
- International Trauma Questionnaire (ITQ)(At baseline (T0).)
- Moral Injury Outcome Scale (MIOS)(At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).)
- Hospital Anxiety and Depression Scale (HADS)(At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).)
- Acceptance and Action Questionnaire (AAQ-II)(At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).)
- Personality Inventory for DSM-5-Brief Form-Adult (PID-5-BF-NL)(At baseline (T0), and at 6 months (T3))
- Dissociative Symptoms Assessment (DSS-4)(At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).)
- Crisis Support Scale (CSS)(At baseline (T0), after 6 months (T3))
- Verbal Learning and Memory Test (VLGT)(At baseline (T0), after weekly treatment (T2, 17 weeks))
- Harms(After intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).)
- Treatment satisfaction(at 7 weeks (T1) and 17 weeks (T2))