Developing and Validating an Integrative Model Incorporating Mindfulness-based Resilience Intervention to Address Post-Traumatic Stress Disorder in People Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Change of PTSD symptoms
研究概览
简要总结
The goal of this randomised controlled trial is to evaluate the efficacy of an integrated intervention program on post-traumatic stress disorder (PTSD) symptoms and related physiological and psychological indicators of people living with HIV (PLWH). The main question it aims to answer are:
- to evaluate the efficacy of the intervention program on PTSD symptoms and related physiological and psychological indicators of PLWH through empirical research.
- to analyze the mechanism of the intervention. Eligible PLWH were recruited and randomly divided as intervention group and control group. The efficacy of Trauma Resiliency Mindfulness-Informed Intervention on PTSD symptoms and related physiological and psychological indicators in PLWH was evaluated at baseline, after intervention, and 3 months after intervention through this randomized controlled trial.
Researchers compared the intervention group and control group to see if it was feasible and had potential clinical value to introduce the Trauma Resiliency Mindfulness-Informed intervention program into the management of PLWH in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- •aged 18 years or older
- •been diagnosed with HIV for more than 1 month
- •screened positive with PTSD CheckList - Civilian Version (PCL-C)
- •voluntary participation
排除标准
- •impaired Verbal Communication
- •have received psychological treatment or related psychological intervention in the past three months
结局指标
主要结局
Change of PTSD symptoms
时间窗: Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention
PTSD CheckList - Civilian Version (PCL-C) was used. The scale consists of 17 items divided into 3 dimensions. Each dimension is scored from 1 to 5. The total score of PCL-C ranges from 17 to 85, with higher scores indicating severer PTSD symptoms.
次要结局
- Change of depression symptoms(Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention)
- Change of rumination(Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention)
- Change of mindfulness(Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention)
- Change of perceived social support(Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention)
- Change of resilience(Outcomes were evaluated at baseline, immediately after the intervention, and 3 months follow-up after the intervention)
研究者
TANG Chulei
Principal investigator
Central South University