A Phase 3 Clinical Trial on Transcendental Meditation and Posttraumatic Stress Disorder, Suicide, and Substance Use in Veterans
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 450
- 主要终点
- PTSD diagnosis and symptoms
研究概览
简要总结
This paper describes the rationale and design of a Phase 3 RCT comparing Transcendental Meditation to Present Centered Therapy for posttraumatic stress disorder (PTSD), suicidal ideation, alcohol use, and depressive symptoms in Veterans. In this multisite trial, 450 Veterans meeting Diagnostic and Statistical Manual-5 (DSM-5) criteria for PTSD will be recruited from nine VA and academic medical center sites across the U.S. Study outcomes include changes in PTSD diagnosis and symptom severity (primary), suicidal ideation, alcohol use, and depressive symptoms. Participation includes baseline testing and post-treatment assessments at 12, 24, and 36-weeks. During each assessment visit, Veterans will complete diagnostic interviews, including the Clinician-Administered PTSD Scale for DSM-5 and the Alcohol Timeline Followback, as well as validated self-report measures. Cost-effectiveness of the treatments will be measured using intervention and healthcare costs, the proportion with PTSD diagnosis removed, and Quality-Adjusted Life Years. Finally, single-site substudies will examine pre-to-post-treatment changes in PTSD biomarkers and on magnetic resonance imaging (MRI).
详细描述
Background: The evidence supporting the Transcendental Meditation (TM) technique as a treatment for posttraumatic stress disorder (PTSD) has advanced considerably in the past decade. With a recent randomized controlled trial (RCT) suggesting statistical superiority to active control treatments for PTSD (e.g., Present Centered Therapy [PCT]) and noninferiority to first-line PTSD psychotherapies, additional research evaluating the benefits and cost-effectiveness of TM for PTSD among Veterans is needed.
Methods and design: This paper describes the rationale and design of a Phase 3 RCT comparing TM to PCT for PTSD in Veterans. In this multisite trial, 450 Veterans meeting DSM-5 criteria for PTSD will be recruited from nine VA and academic medical center sites across the U.S. Study outcomes include changes in PTSD diagnosis and symptom severity (primary), suicidal ideation, alcohol use, and depressive symptoms. Participation includes baseline testing and post-treatment assessments at 12, 24, and 36-weeks. During each assessment visit, Veterans will complete diagnostic interviews, including the Clinician-Administered PTSD Scale for DSM-5 and the Alcohol Timeline Followback, as well as validated self-report measures. Cost-effectiveness of the treatments will be measured using intervention and healthcare costs, the proportion with PTSD diagnosis removed, and Quality-Adjusted Life Years. Finally, single-site substudies will examine pre-to-post-treatment changes in PTSD biomarkers and on magnetic resonance imaging (MRI).
Discussion: Despite progress in PTSD treatments, new evidence-based treatments are still needed for Veterans who drop-out of or respond poorly to existing trauma-focused psychotherapies and that may assist Veterans with common PTSD-comorbidities such as depression, suicidal ideation, and substance use. This multisite trial seeks to advance the science and potential application of TM as a treatment for PTSD in Veterans.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current diagnosis of PTSD from medical record or CAPS-5 interview
- •A symptom severity score≥33 on the CAPS-5 indicating clinically significant PTSD symptoms
- •Three or more months since trauma
- •Agreement to not receive other psychotherapy or meditation for PTSD during the active treatment or follow-up period. Psychotherapy for other problems will be allowed.
- •If being treated with psychoactive medications, a stable regimen (no change in drugs or dose) for at least 2 months before enrollment
- •Age: 18 years or older
- •Language: English literate
排除标准
- •Prior training with TM or treatment with PCT in the past year
- •Currently untreated psychotic symptoms or mania symptoms from chart review or self-report
- •Moderate or greater cognitive impairment indicated by chart diagnosis or observable cognitive difficulties
- •Acute severe symptoms (such as imminent suicidal risk) that will likely require active treatment intervention (such as medication changes) within the course of the study
- •Psychiatric hospitalization in the previous six months
研究组 & 干预措施
PCT
Present Centered Therapy
干预措施: PCT (Behavioral)
TM
Transcendental Mediation
干预措施: TM (Behavioral)
结局指标
主要结局
PTSD diagnosis and symptoms
时间窗: Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) changes in PTSD diagnosis and symptom severity. Scores range from 0-80 with higher scores=higher PTSD symptoms
次要结局
- Suicidal ideation(Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention)
- Depressive symptoms(Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention)
- Alcohol use(Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention)