A Hybrid I Evaluation of Integrative Health Care for PTSD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 9
- 主要终点
- Inventory of Psychosocial Functioning (IPF)
研究概览
简要总结
The goal of this clinical trial is to determine whether which types of integrative care, meaning a combination of psychotherapy and mind-body interventions, lead to the most changes in functioning among Veterans with posttraumatic stress disorder (PTSD). The main aims are:
- To evaluate the impact of integrative care approaches on functional outcomes among Veterans with PTSD.
- To examine factors relevant to the implementation of integrated treatments for PTSD from the perspective of patients, providers and administrators in the VA Healthcare System.
Participants will:
- Complete assessments at the beginning of the study and 12- and 24-weeks later.
- Engage in 12 weeks of integrated care, with the type being randomly assigned.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis
- •eligibility for Cognitive Processing Therapy (CPT) at a participating VA site
- •able to consent to study activities
排除标准
- •current, active engagement in one of the included approaches (per clinician judgment)
- •medical conditions that contraindicate engaging in the experimental interventions
研究组 & 干预措施
Usual care
Information about local and national complementary and integrative health programs
干预措施: Information (Other)
Yoga and meditation
Hatha yoga classes via videoconferencing and self-learning of Mantram Repetition Program
干预措施: Yoga and meditation (Behavioral)
Yoga and meditation
Hatha yoga classes via videoconferencing and self-learning of Mantram Repetition Program
干预措施: Information (Other)
Wellness
Weekly exercise/nutrition classes to support lifestyle changes
干预措施: Wellness (Behavioral)
Wellness
Weekly exercise/nutrition classes to support lifestyle changes
干预措施: Information (Other)
Positive affect
Weekly classes focused on increasing positive affect and social support
干预措施: Positive affect (Behavioral)
Positive affect
Weekly classes focused on increasing positive affect and social support
干预措施: Information (Other)
结局指标
主要结局
Inventory of Psychosocial Functioning (IPF)
时间窗: weeks 0, 12 and 24
The IPF is a self-report measure of functioning across several domains. It is summarized in a mean score with higher scores indicating greater functional impairment.
次要结局
- Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5R)(weeks 0, 12 and 24)
- Quick Inventory of Depressive Symptomatology (QIDS)(weeks 0, 12 and 24)
- Insomnia Severity Index (ISI)(weeks 0, 12 and 24)