Mobile Mindfulness to Improve Psychological Distress After Critical Illness
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Psychological Distress
- Sponsor
- Duke University
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Percent of Eligible Participants Who Provide Informed Consent and Were Randomized
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percent of Eligible Participants Who Provide Informed Consent and Were Randomized
Time Frame: randomization
Percent of eligible participants who provide informed consent and were randomized. A measure of feasibility. Target is 60%.
Client Satisfaction Questionnaire (CSQ) Score
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: baseline, end of study (approx. 4 months)
A usability measure obtained using Google Analytics.
System Usability Scale (SUS)
Time Frame: 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
Time Frame: after intervention completion, up to 8 weeks post-randomization
A measure of acceptability of the intervention. Target mean score is 75% or greater.
Secondary Outcomes
- 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)