Mobile Mindfulness to Improve Psychological Distress After Critical Illness
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|ClinicalTrials.gov Identifier: NCT02701361|
Recruitment Status : Completed
First Posted : March 8, 2016
Results First Posted : January 10, 2018
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Psychological Distress Depression Anxiety Post-traumatic Stress Disorder Informal Caregivers Family Members||Behavioral: mobile mindfulness Behavioral: standard mindfulness Behavioral: education||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Mobile Mindfulness to Improve Psychological Distress After Critical Illness|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||May 1, 2017|
|Actual Study Completion Date :||July 5, 2017|
Active Comparator: 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.
Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials.
Experimental: Standard mindfulness
Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.
Behavioral: standard mindfulness
Receives weekly calls from mindfulness expert for 4 weeks.
Experimental: 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.
Behavioral: mobile mindfulness
Receives audiovisual mindfulness content via internet plus call depending on symptoms or request.
- 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 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Number of Participant Clicks on Study Website [ Time Frame: baseline, end of study (approx. 4 months) ]A usability measure obtained using Google Analytics.
- Change in Psychological Distress Symptoms as Measured by the Patient Health Questionnaire (PHQ) Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 GAD-7 [ Time Frame: 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 PTSS [ Time Frame: 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 [ Time Frame: 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.
- Usability Themes Developed From Semi-structured Participant Interviews [ Time Frame: end of study ]A usability measure. Open-ended feedback questions will be arranged in themes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701361
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Christopher E Cox, MD||Duke University|