Optimizing a Self-directed Mobile Mindfulness Intervention for Improving Cardiorespiratory Failure Survivors' Psychological Distress
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Cardiorespiratory Failure
- 发起方
- Duke University
- 入组人数
- 247
- 试验地点
- 3
- 主要终点
- Patient Health Questionnaire-9 Item Scale (PHQ-9)
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
This is a factorial experimental trial involving adult survivors of cardiorespiratory failure treated in intensive care units (ICUs) that is conceptualized as the Optimization Phase of a multiphase optimization strategy (MOST) framework. This will allow optimization of a mobile mindfulness intervention by comparing eight different iterations across domains including impact on symptoms, feasibility, acceptability, usability, scalability, and cost.
详细描述
As survival has improved for the 2 million people with cardiorespiratory failure managed annually in US intensive care units (ICUs), it has become apparent that these patients suffer from severe and persistent post-discharge symptoms of psychological distress including depression, anxiety, and post-traumatic stress disorder (PTSD). However, few targeted interventions exist that are relevant to patients' experiences and that accommodate their many physical, social, and financial barriers to personalized care. To fill this gap, an innovative app-based mobile mindfulness training program twas developed hat promotes automated care delivery and self-management of symptom-related distress. Subsequently, a pilot randomized clinical trial (RCT) called the LIFT study (R34 AT00819) compared mobile mindfulness to both a standard telephone mindfulness program and an ICU education control among survivors of cardiorespiratory failure. Key findings were that mobile mindfulness was feasibly delivered, acceptable, usable, and had a greater clinical impact on psychological distress than either comparator. This trial also highlighted opportunities to improve the intervention's impact related to its targeted population, content delivery, and system technology. To address these gaps, this 5-year project is conceptualized as the Optimization Phase of a multiphase optimization strategy (MOST) framework. It will optimize mobile mindfulness with four specific aims as described in the following sections. At the conclusion of this factorial randomized clinical trial study involving 240 cardiorespiratory failure survivors, a mobile mindfulness system fully optimized for usability, efficiency, scalability, and clinical impact will be delivered that will be off-the-shelf ready for a next-step definitive RCT-and can serve as a model for distance-based mind and body interventions.
研究者
入排标准
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Patient Health Questionnaire-9 Item Scale (PHQ-9)
时间窗: 1 month post-randomization
Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse)
次要结局
- EuroQOL Scale(Between baseline and 1 month post-randomization)
- Intervention Adherence: Number of Views of Content(1 month post-randomization)
- Distress Associated With Depression Symptom Frequency(At 1 month post-randomization)
- Generalized Anxiety Disorder 7-item Scale (GAD-7)(Between baseline 3 months post-randomization)
- Intervention Adherence: Activity in App During Final Week of Intervention(1 month post-randomization)
- Client Satisfaction Questionnaire (CSQ)(1 month post-randomization)
- Systems Usability Scale (SUS)(1 month post-randomization)
- Change in EuroQOL Scale(Between baseline 3 months post-randomization)
- Patient Health Questionnaire-9 Item Scale (PHQ-9)(Between baseline 3 months post-randomization)
- Post-Traumatic Stress Symptom Inventory (PTSS)(Between baseline and 1 month post-randomization)
- Mindful Attention Awareness Scale (MAAS)(Between baseline 3 months post-randomization)
- Patient Health Questionnaire 10-item Scale (PHQ-10)(Between baseline 3 months post-randomization)
- Distress Associated With PTSD Symptom Frequency(At 3 months post-randomization)
- Distress Associated With Anxiety Symptom Frequency(Between baseline 3 months post-randomization)