Mobile Mindfulness to Improve Psychological Distress After Critical Illness

Not Applicable

Completed

Conditions: Post-traumatic Stress Disorder
Depression
Anxiety
Psychological Distress
Informal Caregivers
Family Members

Interventions: Behavioral: education
Behavioral: standard mindfulness
Behavioral: mobile mindfulness

Registration Number: NCT02701361

Lead Sponsor: Duke University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education group	education	A care condition in which an educational program relevant to critical illness is presented in a web-based format similar to the other arms. Telephone calls will be used to answer questions and assist with web content.
Standard mindfulness	standard mindfulness	Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.
Mobile mindfulness	mobile mindfulness	Receives audiovisual mindfulness content via web-app. Will receive at least 1 call from a trained mindfulness expert, though up to 4 total calls based on symptoms / request.

Primary Outcome Measures

Name	Time	Method
Percent of Eligible Participants Who Provide Informed Consent and Were Randomized	randomization	Percent of eligible participants who provide informed consent and were randomized. A measure of feasibility. Target is 60%.
Client Satisfaction Questionnaire (CSQ) Score	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	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	baseline, end of study (approx. 4 months)	A feasibility measure. Target is 50% among those who neither dropped out nor died.
Percent of Participants in the Self-directed MBT Group Who Complete Weekly Surveys	baseline, end of study (approx. 4 months)	A feasibility measure. Target is 60%. Note that this is for completion of ALL FOUR weekly surveys.
Percent of Eligible Participants Who Provided Consent	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	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%.
Number of Participant Clicks on Study Website	baseline, end of study (approx. 4 months)	A usability measure obtained using Google Analytics.
System Usability Scale (SUS)	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	after intervention completion, up to 8 weeks post-randomization	A measure of acceptability of the intervention. Target mean score is 75% or greater.

Secondary Outcome Measures

Name	Time	Method
Change in Psychological Distress Symptoms as Measured by the GAD-7	Between randomization and 3 months post-randomization	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).
Change in Psychological Distress Symptoms as Measured by the Patient Health Questionnaire (PHQ) Scale	Between randomization and 3 months post-randomization	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).
Change in Distress Associated With Physical Symptoms	Between randomization and 3 months post-randomization	The PHQ-10 (Patient Health Questionnaire) was used to measure distress associated with physical symptoms (range 0 \[none\] to 30 \[very troublesome\]).
Change in Mindfulness Skills	Between randomization and 3 months post-randomization	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 \[highest ability\]).
Change in Psychological Distress Symptoms as Measured by the PTSS	Between randomization and 3 months post-randomization	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.
Change in the Avoidance Domain of the Brief COPE Scale	Between randomization and 3 months post-randomization	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.