Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Access, Engagement, and Effectiveness in Routine Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 428
- 试验地点
- 1
- 主要终点
- PTSD symptom severity
研究概览
简要总结
Less than 20% of people with PTSD receive any treatment. This study extends a program of research by the investigator focused on developing adaptive (stepped) interventions for PTSD. The adaptive intervention sequences a digital mental health intervention (DMHI) and brief trauma- and skills-focused treatments for PTSD. The selected treatments are brief and scalable and less burdensome to systems of care. These treatments are: web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), Brief STAIR, and Written Exposure Therapy (WET).
详细描述
This study uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design.
At baseline, participants are randomized to Stage 1 Treatments, either webSTAIR (self-managed) or webSTAIR plus community health worker coaching. At 8 weeks, stage 1 nonresponders are re-randomized to Stage 2 clinician-administered treatments, either Brief STAIR or WET.
Nonresponse is defined as less than a 15-point decrease in PTSD symptom severity from baseline, as measured by the PTSD Checklist for DSM-5 (PCL-5).
The objectives of this study are to:
- examine the main effects of stage 1 treatments, stage 2 treatments, and embedded
- adaptive interventions on PTSD symptom severity.
- confirm mechanisms of change established in the extant PTSD literature
- identify patient-level moderators of change in PTSD symptoms severity at 18 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Assessed at pre-screening
- •Boston Medical Center primary care patient
- •At least 18 years of age
- •Access to computer or mobile device
- •Able to receive treatments in English or Spanish
- •Able to read at 4th grade level
- •Assessed at baseline
- •Endorsement of Criterion A trauma using the Life Events Checklist for the DSM-5 (LEC-5), assessed at baseline
- •PTSD diagnosis, confirmed by the Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) assessed at baseline
- •- Concordance between CAPS-5 and PCL-5 at baseline
- •Clinically appropriate for outpatient level of care
- •Stable on psychotropic medication for >4 weeks
排除标准
- •Assessed at pre-screening
- •Patient is currently engaged in clinician-administered therapy
- •Assessed at baseline (clinician interview)
- •Patient is not clinically appropriate for outpatient level of care.
- •Acute risk for suicidal thoughts or behaviors, assessed by the Columbia Suicide Severity Rating Scale, administered by research clinician at baseline.
研究组 & 干预措施
webSTAIR to WET
First, offer skills-focused digital mental health intervention (DMHI); then switch to clinician-administered trauma-focused behavioral treatment for nonresponders and continue skills-focused DMHI for responders.
干预措施: webSTAIR (Behavioral)
webSTAIR to WET
First, offer skills-focused digital mental health intervention (DMHI); then switch to clinician-administered trauma-focused behavioral treatment for nonresponders and continue skills-focused DMHI for responders.
干预措施: Clinician administered WET (Behavioral)
webSTAIR+coaching to WET
First, offer skills-focused DMHI plus community health worker (CHW) coaching; then add clinician-administered trauma-focused behavioral treatment for nonresponders and continue skills-focused DMHI for responders.
干预措施: WebSTAIR plus coaching (Behavioral)
webSTAIR+coaching to WET
First, offer skills-focused DMHI plus community health worker (CHW) coaching; then add clinician-administered trauma-focused behavioral treatment for nonresponders and continue skills-focused DMHI for responders.
干预措施: Clinician administered WET (Behavioral)
WebSTAIR to Brief STAIR
First, offer skills-focused DMHI; then add clinician-administered skills-focused behavioral treatment for nonresponders and continue skills-focused DMHI for responders.
干预措施: webSTAIR (Behavioral)
WebSTAIR to Brief STAIR
First, offer skills-focused DMHI; then add clinician-administered skills-focused behavioral treatment for nonresponders and continue skills-focused DMHI for responders.
干预措施: Clinician administered Brief STAIR (Behavioral)
WebSTAIR+coaching to Brief STAIR
First, offer skills-focused DMHI plus CHW coaching; then add clinician-administered skills-focused behavioral treatment for nonresponders and continue skills-focused DMHI plus CHW coaching for responders.
干预措施: WebSTAIR plus coaching (Behavioral)
WebSTAIR+coaching to Brief STAIR
First, offer skills-focused DMHI plus CHW coaching; then add clinician-administered skills-focused behavioral treatment for nonresponders and continue skills-focused DMHI plus CHW coaching for responders.
干预措施: Clinician administered Brief STAIR (Behavioral)
结局指标
主要结局
PTSD symptom severity
时间窗: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks
This outcome will be assessed by the PTSD Checklist for the DSM-5 (PCL-5), a 20-item self-report measure that evaluates the degree to which individuals have been bothered by PTSD symptoms in the past month tied to their most distressing event. Total scores ranging from 0 to 80, and a score of 31-33 or higher suggests probable PTSD and potential benefit from treatment.
Treatment retention
时间窗: 4 weeks, 8 weeks, 18 weeks
as the proportion (%) of participant who complete 60% of interventions in the treatment windows.
Treatment acceptability
时间窗: 4 weeks, 8 weeks, 18 weeks, 30 weeks
This outcome will be assessed with the Client Satisfaction Questionnaire 8 \[CSQ-8\], a 8-item instruction where scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
次要结局
- Treatment expectancy(baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks)
- Medical mistrust(baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks)
- Posttraumatic cognitions(baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks)
- Pathological fear extinction(baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks)
- Trauma coping self-efficacy(baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks)
- Trauma coping(baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks)
- Treatment expectancy(baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks)
- Mental health stigma(baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks)
- Medical mistrust(baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks)
- Posttraumatic cognitions(baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks)
- Pathological fear extinction(baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks)