Feasibility and Acceptability of an mHealth Cognitive Behavioral Stress Management Intervention to Ameliorate HIV-related Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility and Acceptability Scale
研究概览
简要总结
The purpose of this study is to create a smartphone, tablet and web-based application to help people deal with stress. Stress often increases fatigue in people with HIV infection, so successfully dealing with stress could help reduce HIV-related fatigue. The study is being done at one site, the Medical University of South Carolina. Approximately 30 people will take part in this portion of the study.
详细描述
For this study we will develop a fatigue symptom self-management cognitive behavioral stress management (CBSM) program that will be delivered via mHealth through smartphones and tablets (optimized for each). All CBSM content will be integrated into the application, but tailoring of information delivery will be derived through algorithm-driven feedback based on user input as they respond to integrated assessment and symptom monitoring questions. As a result, users of the CBSM-Self Management Intervention (CBSM-SMI) will receive personalized, relevant intervention content, when they need it, where they need it. This novel mode of CBSM delivery has not yet been provided via an mHealth format to HIV-infected individuals, despite its obvious advantages insofar as cost and reach are concerned.
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
- 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
- •HIV positive
- •Reads and understands English
- •Scores greater than 5 on the HIV-Related Fatigue Scale
- •Mentally competent to give informed consent
排除标准
- •Co-morbid conditions marked by fatigue (e.g., renal disease, cancer, multiple sclerosis)
- •Pregnant women and women who are less than 1 year postpartum
- •Active psychosis or dementia
- •Suicidal ideation with clear intent
- •Current substance dependence
结局指标
主要结局
Feasibility and Acceptability Scale
时间窗: 22 weeks
The Feasibility and Acceptability Scale is a 5 item, 5-point scale, developed to assess the feasibility and acceptability of interventions.
次要结局
- Beck Depression Inventory (BDI-II)(22 weeks)
- CD4 count from the medical record(22 weeks)
- PROMIS Short Form - Fatigue 8a(22 weeks)
- Life Experiences Scale(22 weeks)
- HIV viral load information from the medical record(22 weeks)
- HIV-Related Fatigue Scale (HRFS)(22 weeks)
- The State Trait Anxiety Inventory (STAI)-State(22 weeks)