Trial Outcomes & Findings for Mobile Mindfulness to Improve Psychological Distress After Critical Illness (NCT NCT02701361)

NCT ID: NCT02701361

Last Updated: 2018-02-07

Results Overview

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%.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 90 participants
• Primary outcome timeframe: pre-randomization
• Results posted on: 2018-02-07

Participant Flow

90 participants signed consent; 2 participants who signed consent were later found not to be eligible(88 eligible). 80 participants were randomized

Participant milestones

Measure	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. mobile mindfulness: Receives audiovisual mindfulness content via internet plus call depending on symptoms or request.	Standard Mindfulness Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert. standard mindfulness: Receives weekly calls from mindfulness expert for 4 weeks.	Education Group 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. education: Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials.
Overall Study STARTED	31	31	18
Overall Study COMPLETED	22	28	16
Overall Study NOT COMPLETED	9	3	2

Reasons for withdrawal

Measure	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. mobile mindfulness: Receives audiovisual mindfulness content via internet plus call depending on symptoms or request.	Standard Mindfulness Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert. standard mindfulness: Receives weekly calls from mindfulness expert for 4 weeks.	Education Group 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. education: Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials.
Overall Study Lost to Follow-up	5	2	1
Overall Study Withdrawal by Subject	4	0	0
Overall Study timed out in rehab center	0	1	0
Overall Study incarceration	0	0	1

Baseline Characteristics

Mobile Mindfulness to Improve Psychological Distress After Critical Illness

Baseline characteristics by cohort

Measure	Mobile Mindfulness n=31 Participants 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. mobile mindfulness: Receives audiovisual mindfulness content via internet plus call depending on symptoms or request.	Standard Mindfulness n=31 Participants Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert. standard mindfulness: Receives weekly calls from mindfulness expert for 4 weeks.	Education Group n=18 Participants 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. education: Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials.	Total n=80 Participants Total of all reporting groups
Age, Continuous	48.7 years STANDARD_DEVIATION 15.3 • n=5 Participants	48.1 years STANDARD_DEVIATION 16.1 • n=7 Participants	53.3 years STANDARD_DEVIATION 12.6 • n=5 Participants	49.5 years STANDARD_DEVIATION 15.1 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	15 Participants n=7 Participants	8 Participants n=5 Participants	35 Participants n=4 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	16 Participants n=7 Participants	10 Participants n=5 Participants	45 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	30 Participants n=7 Participants	18 Participants n=5 Participants	79 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	18 Participants n=4 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	20 Participants n=7 Participants	10 Participants n=5 Participants	53 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: pre-randomization

Population: 121, not 90 subjects, are analyzed because this outcome measure applies to a pre-consent and pre-randomization time period.

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%.

Outcome measures

Measure	All Eligible Subjects Approached to Participate in the Study n=121 Participants All eligible subjects approached to participate in the study.	Standard Mindfulness Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.	Education Group 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.
Percent of Eligible Participants Who Provided Consent	90 Participants	—	—

PRIMARY outcome

Timeframe: randomization

Population: Following consent, two participants were found to be ineligible.

Percent of eligible participants who provide informed consent and were randomized. A measure of feasibility. Target is 60%.

Outcome measures

Measure	All Eligible Subjects Approached to Participate in the Study n=88 Participants All eligible subjects approached to participate in the study.	Standard Mindfulness Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.	Education Group 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.
Percent of Eligible Participants Who Provide Informed Consent and Were Randomized	80 Participants	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	All Eligible Subjects Approached to Participate in the Study n=22 Participants All eligible subjects approached to participate in the study.	Standard Mindfulness n=28 Participants Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.	Education Group n=16 Participants 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.
Client Satisfaction Questionnaire (CSQ) Score	27.6 units on a scale Standard Deviation 3.8	29.4 units on a scale Standard Deviation 3.3	25.7 units on a scale Standard Deviation 3.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	All Eligible Subjects Approached to Participate in the Study n=22 Participants All eligible subjects approached to participate in the study.	Standard Mindfulness Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.	Education Group 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.
System Usability Scale (SUS)	86.5 units on a scale Standard Deviation 13.3	—	—

PRIMARY outcome

Timeframe: baseline, end of study (approx. 4 months)

A feasibility measure. Target is 20% or less.

Outcome measures

Measure	All Eligible Subjects Approached to Participate in the Study n=31 Participants All eligible subjects approached to participate in the study.	Standard Mindfulness n=31 Participants Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.	Education Group n=18 Participants 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.
Percent of Randomized Participants Who Drop Out of Study before intervention initiated	7 Participants	2 Participants	0 Participants
Percent of Randomized Participants Who Drop Out of Study after intervention initiated	2 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: 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%.

Outcome measures

Measure	All Eligible Subjects Approached to Participate in the Study n=22 Participants All eligible subjects approached to participate in the study.	Standard Mindfulness n=28 Participants Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.	Education Group n=16 Participants 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.
Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews	22 Participants	28 Participants	16 Participants

PRIMARY outcome

Timeframe: baseline, end of study (approx. 4 months)

A feasibility measure. Target is 60%. Note that this is for completion of ALL FOUR weekly surveys.

Outcome measures

Measure	All Eligible Subjects Approached to Participate in the Study n=22 Participants All eligible subjects approached to participate in the study.	Standard Mindfulness Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.	Education Group 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.
Percent of Participants in the Self-directed MBT Group Who Complete Weekly Surveys	17 Participants	—	—

PRIMARY outcome

Timeframe: baseline, end of study (approx. 4 months)

A feasibility measure. Target is 50% among those who neither dropped out nor died.

Outcome measures

Measure	All Eligible Subjects Approached to Participate in the Study n=22 Participants All eligible subjects approached to participate in the study.	Standard Mindfulness Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.	Education Group 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.
Percentage of Self-directed MBT Sessions Attended by Eligible Participants	22 Participants	—	—

PRIMARY outcome

Timeframe: after intervention completion, up to 8 weeks post-randomization

Population: measure was mistakenly omitted from study CRF and therefore data not collected.

A measure of acceptability of the intervention. Target mean score is 75% or greater.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: baseline, end of study (approx. 4 months)

A usability measure obtained using Google Analytics.

Outcome measures

Measure	All Eligible Subjects Approached to Participate in the Study n=22 Participants All eligible subjects approached to participate in the study.	Standard Mindfulness Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.	Education Group 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.
Number of Participant Clicks on Study Website	188.4 clicks Standard Deviation 220.8	—	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	All Eligible Subjects Approached to Participate in the Study n=31 Participants All eligible subjects approached to participate in the study.	Standard Mindfulness n=31 Participants Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.	Education Group n=18 Participants 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.
Change in Psychological Distress Symptoms as Measured by the Patient Health Questionnaire (PHQ) Scale	-4.8 units on a scale Interval -6.6 to -2.9	-3.9 units on a scale Interval -5.6 to -2.2	-3.0 units on a scale Interval -5.3 to -0.8

SECONDARY outcome

Timeframe: 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]).

Outcome measures

Measure	All Eligible Subjects Approached to Participate in the Study n=31 Participants All eligible subjects approached to participate in the study.	Standard Mindfulness n=31 Participants Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.	Education Group n=18 Participants 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.
Change in Distress Associated With Physical Symptoms	-5.3 units on a scale Interval -7.0 to -3.7	-3.7 units on a scale Interval -5.2 to -2.2	-4.8 units on a scale Interval -6.8 to -2.7

SECONDARY outcome

Timeframe: 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]).

Outcome measures

Measure	All Eligible Subjects Approached to Participate in the Study n=31 Participants All eligible subjects approached to participate in the study.	Standard Mindfulness n=31 Participants Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.	Education Group n=18 Participants 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.
Change in Mindfulness Skills	0.7 units on a scale Interval -1.7 to 3.0	-0.9 units on a scale Interval -3.1 to 1.3	-1.3 units on a scale Interval -4.1 to 1.5

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	All Eligible Subjects Approached to Participate in the Study n=31 Participants All eligible subjects approached to participate in the study.	Standard Mindfulness n=31 Participants Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.	Education Group n=18 Participants 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.
Change in Psychological Distress Symptoms as Measured by the GAD-7	-2.1 units on a scale Interval -3.7 to -0.5	-1.6 units on a scale Interval -3.0 to -0.1	-0.6 units on a scale Interval -2.5 to 1.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	All Eligible Subjects Approached to Participate in the Study n=31 Participants All eligible subjects approached to participate in the study.	Standard Mindfulness n=31 Participants Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.	Education Group n=18 Participants 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.
Change in Psychological Distress Symptoms as Measured by the PTSS	-2.6 units on a scale Interval -6.3 to 1.2	-2.2 units on a scale Interval -5.6 to 1.2	-3.5 units on a scale Interval -8.0 to 1.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	All Eligible Subjects Approached to Participate in the Study n=31 Participants All eligible subjects approached to participate in the study.	Standard Mindfulness n=31 Participants Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.	Education Group n=18 Participants 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.
Change in the Avoidance Domain of the Brief COPE Scale	-0.5 units on a scale Interval -1.9 to 1.0	1.3 units on a scale Interval -0.03 to 2.7	-0.2 units on a scale Interval -2.0 to 1.6

OTHER_PRE_SPECIFIED outcome

Timeframe: end of study

A usability measure. Open-ended feedback questions will be arranged in themes.

Outcome measures

Outcome data not reported

Adverse Events

Mobile Mindfulness

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Mindfulness

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Education Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christopher Cox

Duke University Health System

Phone: 9196817232

Email: christopher.cox@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place