A Randomized Controlled Trial Comparing Brief Peer Supported webSTAIR to Enhanced Wait List
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Change from Baseline on PTSD Checklist for DSM-5 (PCL-5) at program completion and at two months after program completion.
研究概览
简要总结
This study will enroll 180 Veterans at a 2:1 ratio where 120 Veterans will be enrolled into a brief transdiagnostic peer supported webSTAIR (BPS webSTAIR) and 60 will be supported into Waitlist. The purpose of the study is to assess the efficacy BPS webSTAIR in regard to four outcomes: reduction in PTSD and depression symptoms (measured by the PCL-5 and PHQ-8, respectively) and improvement in emotion regulation and work and social adjustment (measured by the DERS-16 and WSAS, respectively). The active treatment is a 6-session modular treatment that focuses on learning emotion management skills where Particpants will have 10 weeks to complete the treatment. Assessments will occur three times for those in webSTAIR: baseline, post-treatment (10 weeks after randomization) and 8-week follow-up and twice for those on waitlist (baseline and 10 weeks after randomization). It is hypothesized that BPS WebSTAIR will be superior to the Waitlist condition on all four outcomes. Mixed Effects Models will be used to evaluate the outcomes.
详细描述
The purpose of this randomized controlled trial is to assess the efficacy of a brief version of webSTAIR (BPS webSTAIR) supported by peers compared to a waitlist condition (WL). Brief peer supported (BPS) webSTAIR is a 6-module web-based transdiagnostic program that provides skills training in emotion regulation; participants in this condition will be able to contact a Veteran peer trained in the program to obtain general support plus guidance about program use and application of skills.
An 11-module version of webSTAIR with therapist coaching has provided pilot data that the program is effective in reducing symptoms of posttraumatic stress disorder (PTSD) and depression as well as improving emotion regulation and work and social adjustment. Pilot data indicate that initial gains are made in the first 6 sessions. In addition, qualitative interviews with Veterans who have completed the program indicate high satisfaction with these modules. This study will assess whether a shorter version of the treatment (6 rather than 11 modules) and with peer rather than professional coaching will be effective compared to a waitlist condition. The BPS webSTAIR program was developed with the aim of providing a treatment for trauma-related symptoms that is effective, brief, engaging and likely to be completed by the user. The reduction of the number of modules creates a briefer treatment than the investigators current web-based program. In addition, data indicated that integrating Veteran peers into mental health programs leads to better engagement and greater retention providing the rationale for including Veteran peers rather than therapists (e.g., psychologists, social workers). Given the absence of findings that a brief, peer-supported version of webSTAIR provides improvement in the above symptoms, the research team followed recommendations for the development and testing of psychotherapies and used a waitlist control as an initial test of efficacy.
The aim is to establish the efficacy of BPS webSTAIR in improving symptoms of PTSD and depression, emotion regulation problems and work and social adjustment compared to a Waitlist Control.
Hypothesis 1a: Compared to WL, BPS webSTAIR will provide greater improvement in PTSD symptoms as measured by the PCL5 and depression as measured by the PHQ-8 (secondary outcome). Assessments will be made at pre-treatment, post-treatment, and 8-week follow-up for webSTAIR participants and pre and post-treatment (or 10 weeks from randomization) for WL.
Hypothesis 1b: Compared to WL, BPS webSTAIR will provide greater improvement in emotion regulation as measured by the DERS-16 and overall functioning as measured by the work and social adjustment scale (WSAS) (secondary outcomes). Assessments will be made at pre-treatment, post-treatment and 8-week follow-up for webSTAIR participants and pre and post-treatment (or 10 weeks after randomization) for WL.
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)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read/write English
- •Internet connection allowing stable access to VetsPrevail website
- •Have experienced at least one traumatic event (positive on the LEC)
- •A score greater than or equal to 3 on the PC-PTSD OR greater than or equal to 2 on the PHQ2 on the screen.
- •Enrollment into the webSTAIR study must be completed within two weeks of completing screener/eligibility based on symptoms.
排除标准
- •Currently receiving a trauma-focused intervention (PE, CPT, EMDR, WET) assessed during baseline
- •Being unlikely to benefit from therapy or Telemental health, for example:
- •Cognitive difficulties as indicated during baseline assessment.
- •Active psychosis as indicated during baseline assessment
结局指标
主要结局
Change from Baseline on PTSD Checklist for DSM-5 (PCL-5) at program completion and at two months after program completion.
时间窗: Before the participant is randomized. 10 weeks from randomization. 2 months after the participant finishes all 6 levels of the intervention for participants engaged in treatment.
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including, monitoring symptom change during and after treatment, screening individuals for PTSD and making a provisional PTSD diagnosis. The scale ranges from Not At All (0) to Extremely (4) Higher scores relate to more severe symptoms.
Change from Baseline on Personal Health Questionnaire Depression Scale (PHQ - 8) at program completion and at two months after program completion.
时间窗: Before the participant is randomized. 10 weeks from randomization. 2 months after the participant finishes all 6 levels of the intervention for participants engaged in treatment.
The eight-item Personal Health Questionnaire Depression Scale (PHQ - 8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies.The scale ranges from Not At All (1) to Nearly Every Day (4) Higher scores relate to more severe symptoms.
Life Events Checklist for DSM-5 (LEC-2)
时间窗: Before the participant is randomized to a condition.
The Life Events Checklist for DSM-5 (LEC-2) lists difficult or stressful things that sometimes happen to people. Mark the item for any single stressful event you have experienced. Be sure to consider your entire life (growing up, as well as adulthood) as you go through the list of events. You do not need to answer any of these questions if doing so would be distressing. The scale consists of Yes, No and Prefer Not To Answer. More Yes responses indicate experiencing more traumatic events in a participant's history.
Change from Baseline on Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) at program completion and at two months after program completion.
时间窗: Before the participant is randomized. 10 weeks from randomization. 2 months after the participant finishes all 6 levels of the intervention for participants engaged in treatment.
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16) is a widely-used, theoretically-driven, and psychometrically-sound self-report measure of emotion regulation difficulties. The scale ranges from Almost Never (1) to Almost Always (5). Higher scores relate to more severe symptoms.
Change from Baseline on The Work and Social Adjustment Scale (WSAS) at program completion and at two months after program completion.
时间窗: Before the participant is randomized. 10 weeks from randomization. 2 months after the participant finishes all 6 levels of the intervention for participants engaged in treatment.
The The Work and Social Adjustment Scale (WSAS) is a measure of people's problems sometimes affect their ability to do certain day-to-day tasks in their lives. To rate your problems, look at each section and determine on the scale provided how much your problem impairs your ability to carry out the activity in the past month.The scale ranges from No Impairment (0) to Very Severe Impairment (8). Higher scores relate to more severe impairment.
次要结局
未报告次要终点
研究者
Marylène Cloitre
Principal Investigator
Palo Alto Veterans Institute for Research