Mobile Mindfulness to Improve Psychological Distress After Critical Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Percent of Eligible Participants Who Provide Informed Consent and Were Randomized
研究概览
简要总结
Many survivors of the intensive care unit (ICU) suffer from persistent symptoms of depression, anxiety, and post-traumatic stress disorder (PTSD). In this study, the investigators will test the impact of mindfulness to address this distress.
详细描述
A majority of the >1 million people who require life support in an intensive care unit (ICU) now survive. As survival has improved however, growing numbers suffer not only from subsequent physical disability, but also persistent symptoms of depression, anxiety, and post-traumatic stress disorder (PTSD). Few interventions address ICU survivors' psychological distress. Fewer still address the physical, geographical, and logistical barriers to receiving post-discharge support that medically ill populations encounter. Consequently, this population suffers with an unmet need of great public health importance.
Mindfulness is an adaptable self-regulation practice that alleviates psychological distress symptoms using a variety of meditative techniques, typically taught face-to face over months. As an extension of standard mindfulness practices, the investigators developed a telephone-/web-delivered mobile mindfulness-based training (mMBT) system informed by ICU survivors' input that could address medically ill patients' delivery barriers. The investigators' recent pilot study demonstrated early support for mMBT's feasibility and acceptability, now with enhanced content and electronic patient-reported outcomes capability.
The investigators' early work on mMBT, while promising, identified key knowledge gaps in population targeting, plausible ranges of psychological distress estimates relevant to study design, and assurance of acceptability that must be addressed before a definitive clinical trial is conducted. Therefore, the study team proposes a 2-year pilot study in which 90 ICU survivors are randomized to an education control, 'standard' telephone sessions of mMBT, or self-directed / app-based mMBT. A mixed methods approach will be used to determine treatment effect.
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
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percent of Eligible Participants Who Provide Informed Consent and Were Randomized
时间窗: randomization
Percent of eligible participants who provide informed consent and were randomized. A measure of feasibility. Target is 60%.
Client Satisfaction Questionnaire (CSQ) Score
时间窗: 1 month post-randomization
Acceptability was measured with the adapted Client Satisfaction Questionnaire (CSQ), which assesses credibility and satisfaction (range 9 \[low, a worse outcome\] to 36 \[highest, a better outcome\]). Target is mean score \>10.
Percent of Randomized Participants Who Drop Out of Study
时间窗: baseline, end of study (approx. 4 months)
A feasibility measure. Target is 20% or less.
Percentage of Self-directed MBT Sessions Attended by Eligible Participants
时间窗: baseline, end of study (approx. 4 months)
A feasibility measure. Target is 50% among those who neither dropped out nor died.
Percent of Eligible Participants Who Provided Consent
时间窗: pre-randomization
Percent of eligible participants who provided consent. Because this includes eligible yet not-as-yet randomized participants, there are no study arm differences analyzed. This is a feasibility measure. Target is 70%.
Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews
时间窗: baseline, end of study (approx. 4 months)
Percent of participants who have neither dropped out nor died who complete telephone interviews. A feasibility measure. Target is 75%.
Percent of Participants in the Self-directed MBT Group Who Complete Weekly Surveys
时间窗: baseline, end of study (approx. 4 months)
A feasibility measure. Target is 60%. Note that this is for completion of ALL FOUR weekly surveys.
Number of Participant Clicks on Study Website
时间窗: baseline, end of study (approx. 4 months)
A usability measure obtained using Google Analytics.
System Usability Scale (SUS)
时间窗: 1 month post-randomization
Usability of the mobile app was assessed with open-ended participant feedback and with the 10-item System Usability Scale (SUS; 0 \[lowest\] to 100 \[highest\]). A SUS score above a 68 would be considered above average and anything below 68 is below average.
Visual Analog Satisfaction Scale
时间窗: after intervention completion, up to 8 weeks post-randomization
A measure of acceptability of the intervention. Target mean score is 75% or greater.
次要结局
- Change in Psychological Distress Symptoms as Measured by the GAD-7(Between randomization and 3 months post-randomization)
- Change in Psychological Distress Symptoms as Measured by the Patient Health Questionnaire (PHQ) Scale(Between randomization and 3 months post-randomization)
- Change in Distress Associated With Physical Symptoms(Between randomization and 3 months post-randomization)
- Change in Mindfulness Skills(Between randomization and 3 months post-randomization)
- Change in Psychological Distress Symptoms as Measured by the PTSS(Between randomization and 3 months post-randomization)
- Change in the Avoidance Domain of the Brief COPE Scale(Between randomization and 3 months post-randomization)