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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Receives audiovisual mindfulness content via internet plus call depending on symptoms or request.
Receives weekly calls from mindfulness expert for 4 weeks.
Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials.
Duke University
Durham, North Carolina, United States
University of Washington
Seattle, Washington, United States
Percent of Eligible Participants Who Provided Consent
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%.
Time frame: pre-randomization
Percent of Eligible Participants Who Provide Informed Consent and Were Randomized
Percent of eligible participants who provide informed consent and were randomized. A measure of feasibility. Target is 60%.
Time frame: randomization
Client Satisfaction Questionnaire (CSQ) Score
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.
Time frame: 1 month post-randomization
System Usability Scale (SUS)
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.
Time frame: 1 month post-randomization
Percent of Randomized Participants Who Drop Out of Study
A feasibility measure. Target is 20% or less.
Time frame: baseline, end of study (approx. 4 months)
Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews
Percent of participants who have neither dropped out nor died who complete telephone interviews. A feasibility measure. Target is 75%.
Time frame: baseline, end of study (approx. 4 months)
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Percent of Participants in the Self-directed MBT Group Who Complete Weekly Surveys
A feasibility measure. Target is 60%. Note that this is for completion of ALL FOUR weekly surveys.
Time frame: baseline, end of study (approx. 4 months)
Percentage of Self-directed MBT Sessions Attended by Eligible Participants
A feasibility measure. Target is 50% among those who neither dropped out nor died.
Time frame: baseline, end of study (approx. 4 months)
Visual Analog Satisfaction Scale
A measure of acceptability of the intervention. Target mean score is 75% or greater.
Time frame: after intervention completion, up to 8 weeks post-randomization
Number of Participant Clicks on Study Website
A usability measure obtained using Google Analytics.
Time frame: baseline, end of study (approx. 4 months)
Change in Psychological Distress Symptoms as Measured by the Patient Health Questionnaire (PHQ) Scale
Depression symptoms were assessed with the PHQ-9, a 9-item scale (range 0 \[no distress\] to 27 \[high distress\]); symptom severity is interpreted as mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).
Time frame: Between randomization and 3 months post-randomization
Change in Distress Associated With Physical Symptoms
The PHQ-10 (Patient Health Questionnaire) was used to measure distress associated with physical symptoms (range 0 \[none\] to 30 \[very troublesome\]).
Time frame: Between randomization and 3 months post-randomization
Change in Mindfulness Skills
Mindfulness skills were measured with the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R), a 12-item measure of mindful qualities (range 12 \[low ability\] to 48 \[highest ability\]).
Time frame: Between randomization and 3 months post-randomization
Change in Psychological Distress Symptoms as Measured by the GAD-7
Anxiety symptoms were measured using the Generalized Anxiety Disorder 7-item scale (GAD-7; range 0 \[no distress\] to 21 \[high distress\]); symptom severity is interpreted as mild (5-9), moderate (10-14), and severe (15-21).
Time frame: Between randomization and 3 months post-randomization
Change in Psychological Distress Symptoms as Measured by the PTSS
The Post Traumatic Stress Scale (PTSS), a 10-item scale (range 10 \[no symptoms\] to 70 \[high burden of symptoms\]), was used to assess PTSD symptoms; \>20 represents clinically important symptoms.
Time frame: Between randomization and 3 months post-randomization
Change in the Avoidance Domain of the Brief COPE Scale
Coping skills were measured with the Brief COPE scale (range 10 \[low use\] to 40 \[highest use\]). The Brief COPE is a self-report questionnaire used to assess a number of different coping behaviors and thoughts a person may have in response to a specific situation.
Time frame: Between randomization and 3 months post-randomization