Mobile Mindfulness to Improve Psychological Distress After Critical Illness

Duke University4 个研究点分布在 1 个国家目标入组 90 人开始时间: 2016年3月1日最近更新: 2018年2月7日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
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

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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

•(the investigators will target patients at high risk for psychological distress):
•age ≥18 years
•acute cardiorespiratory failure managed in an intensive care unit
•reside at home before hospital admission (i.e., not in a facility)
•Respiratory failure, ≥1 of these:
•mechanical ventilation via endotracheal tube for ≥ 12 hours
•non-invasive ventilation (CPAP, BiPAP) for > 4 hours in a 24 hour period provided for acute respiratory failure in an ICU (not for obstructive sleep apnea or other stable use)
•high flow nasal cannula or face mask O2 with FiO2 ≥ 0.5 for ≥4 hours
•Cardiac / circulatory failure, ≥1 of these:
•use of vasopressors for shock of any etiology for > 1 hour
•use of inotropes for shock of any etiology for > 1 hour
•use of aortic balloon pump for cardiogenic shock

排除标准

•(present before consent): Patients will be excluded if they have characteristics that would prohibit adequate participation including:
•pre-existing significant cognitive impairment (e.g., dementia)
•treated for severe or unstable mental illness within 6 months preceding current admission (e.g., depression with psychosis, suicidality, schizophrenia as per medical record)
•hospital inpatient within 3 months before current admission
•active substance abuse at the time of admission
•lack of decisional capacity [*'Decisional capacity' is defined as the ability to participate in effective decision making and provide informed consent. That is, in the judgment of the examiner, the patient, after reading the IRB approved patient consent document (or having it read to them) can (a) generally understand the terms of participation in the study: the purpose of the study, what will be required of study participants; the potential risks, benefits and alternatives of study participation; pros & cons of study involvement and (b) can communicate a choice in his/her own words (or write on a communication board)]
•current significant cognitive impairment (≥3 errors on the Callahan cognitive status screen; see below)
•need for a translator because of poor English fluency [many study instruments are not validated in other languages]
•expected survival <6 months per attending physician
•ICU length of stay >30 days
•lack of either:
•reliable or sufficient smartphone with cellular data plan or
•reliable computer online access plus telephone access
•unable to complete study procedures as determined by study staff
•discharge to a location other than a home setting
•complex medical care expected soon after discharge (e.g., multiple planned surgeries, transplantation evaluation (including outpatient daily cardiopulmonary rehabilitation), extensive travel needs for hemodialysis, disruptive chemotherapy or XRT regimen, etc)
•Other issues relevant to the consent process:
•unable to approach patient for logistical reasons (e.g., off ward in test at time of approach, etc)
•patient discharged before consent could be obtained
•patient dies before consent obtained
•Patient exclusion criteria present after consent but before randomization:
•After providing informed consent, patients will become ineligible if any of the following are present:
•they become too ill to participate (or die)
•they exhibit significant cognitive disability
•they exhibit suicidality
•patient was unexpectedly discharged to location other than a home setting and then did not arrive home within 1 month from hospital discharge

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