Enhancing Executive Function and Self-regulation Success Through the Promotion of Brain Health Behaviors: a Telehealth Pilot Study for Veterans with Chronic Multi-symptom Illness.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Feasibility (Recruitment rate)
研究概览
简要总结
The objective of this pilot study is to examine the feasibility, safety, and acceptability of a telehealth meditation and physical activity (MAP) intervention among Veterans with chronic multi-symptom illness.
详细描述
This pilot study innovatively merges with ongoing clinical practice at the War Related Illness and Injury Study Center to explore the utility of new VA technologies and distance-bridging approaches for administering a remote intervention that promotes health behaviors (e.g., physical activity and meditation, called mental and physical training or MAP). Not only does this study intend to examine the feasibility of using these tools within the home setting and integrating these practices into the weekly lives of Veterans, but it also aims to determine the best way to administer this type of intervention by comparing a directed MAP (dMAP) intervention arm to a self-guided MAP (sgMAP) intervention arm. Understanding how much guidance to provide Veterans during their path towards recovery is important since we hope that this pilot study will offer not only evidence that these practices can be administered without supervision but also reveal that giving Veterans the right tools (exercise and meditation app on tablet), guidance (directed text message or holistic goals), and support (video-chat health coaching) can have measurable benefits on symptom severity and function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Previously deployed Veterans
- •Experiencing Chronic Multisymptom Illness defined using the Fukuda criteria.
- •Able to engage in physical activity
- •Has a smart phone
- •Co-enrolled in the WRIISC Data Repository Study
排除标准
- •Excessive alcohol consumption (AUDIT Score >= 4 (men); AUDIT Score >= 3 (women))
- •Current or previous drug use past 90 days.
- •Current prominent suicide or homicidal ideation
- •Recent exposure to trauma
- •Acute or unstable illness
- •Dementia or significant cognitive impairments
结局指标
主要结局
Feasibility (Recruitment rate)
时间窗: Through study completion, an average of 6 months
Recruitment rate was calculated as the number of participants who consented into the study divided by the number of eligible WRIISC patients who were approached during enrollment.
Feasibility (Retention rate)
时间窗: Through study completion, an average of 6 months
Retention rate was calculated for each time point (endpoint and 3m follow-up) and reported as a percentage.
Feasibility (Adherence rate)
时间窗: Through study completion, an average of 6 months
Due to the multiple components of the intervention, adherence rates were calculated for the meditation and exercise components separately and overall adherence to the MAP training protocol.
Safety of administering a telehealth MAP intervention
时间窗: Through study completion, an average of 6 months
Number of adverse events reported during the intervention
Acceptability
时间窗: Through study completion, an average of 6 months
Acceptability was quantified using the qualitative feedback provided by participants during their health coaching sessions.
次要结局
- Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)(Baseline to Endpoint (2 months) and baseline to 5 months.)
- Patient Health Questionnaire- Depression scale (PHQ-9)(Baseline to Endpoint (2 months) and baseline to 5 months.)
- Posttraumatic Symptom Checklist - Military version (PCL-M)(Baseline to Endpoint (2 months) and baseline to 5 months.)
- Perceived Stress Scale (PSS)(Baseline to Endpoint (2 months) and baseline to 5 months.)
- Brief Symptom Inventory (BSI)(Baseline to Endpoint (2 months) and baseline to 5 months.)
- Five-Factor Mindfulness Questionnaire (FFMQ)(Baseline to Endpoint (2 months) and baseline to 5 months.)
- Medical Outcomes Study Short-Form-36 version 2 (SF-36v2)(Baseline to Endpoint (2 months) and baseline to 5 months.)
- Cognitive Difficulties Scale (CDS)(Baseline to Endpoint (2 months) and baseline to 5 months.)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline to Endpoint (2 months) and baseline to 5 months.)