Mobile Mindfulness to Improve Psychological Distress After Critical Illness

NCT02701361 | Completed Results DMC

• 2 other identifiers: Pro00064250R34AT008819
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

mindfulness; critical illness; intensive care unit; mindfulness-based stress reduction

Outcome Measures

Primary Outcomes (10)

• 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%.

  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%.

  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.

  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.

  1 month post-randomization

• Percent of Randomized Participants Who Drop Out of Study

  A feasibility measure. Target is 20% or less.

  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%.

  baseline, end of study (approx. 4 months)

• 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.

  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.

  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.

  after intervention completion, up to 8 weeks post-randomization

• Number of Participant Clicks on Study Website

  A usability measure obtained using Google Analytics.

  baseline, end of study (approx. 4 months)

Secondary Outcomes (6)

• 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 GAD-7

  Between randomization and 3 months post-randomization

• Change in Psychological Distress Symptoms as Measured by the PTSS

  Between randomization and 3 months post-randomization

Other Outcomes (1)

• Usability Themes Developed From Semi-structured Participant Interviews

  end of study

Study Arms (3)

Education group

ACTIVE COMPARATOR

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.

Behavioral: education

Standard mindfulness

EXPERIMENTAL

Receives audiovisual mindfulness content via internet plus 1 call per week from a trained mindfulness expert.

Behavioral: standard mindfulness

Mobile mindfulness

EXPERIMENTAL

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

Interventions

mobile mindfulness BEHAVIORAL

Receives audiovisual mindfulness content via internet plus call depending on symptoms or request.

Mobile mindfulness

standard mindfulness BEHAVIORAL

Receives weekly calls from mindfulness expert for 4 weeks.

Standard mindfulness

education BEHAVIORAL

Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials.

Education group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years
• acute cardiorespiratory failure managed in an intensive care unit
• reside at home before hospital admission (i.e., not in a facility)
• Respiratory failure, ≥1 of these:
• mechanical ventilation via endotracheal tube for ≥ 12 hours
• non-invasive ventilation (CPAP, BiPAP) for \> 4 hours in a 24 hour period provided for acute respiratory failure in an ICU (not for obstructive sleep apnea or other stable use)
• high flow nasal cannula or face mask O2 with FiO2 ≥ 0.5 for ≥4 hours
• Cardiac / circulatory failure, ≥1 of these:
• use of vasopressors for shock of any etiology for \> 1 hour
• use of inotropes for shock of any etiology for \> 1 hour
• use of aortic balloon pump for cardiogenic shock

You may not qualify if:

• pre-existing significant cognitive impairment (e.g., dementia)
• treated for severe or unstable mental illness within 6 months preceding current admission (e.g., depression with psychosis, suicidality, schizophrenia as per medical record)
• hospital inpatient within 3 months before current admission
• active substance abuse at the time of admission
• lack of decisional capacity \[\*'Decisional capacity' is defined as the ability to participate in effective decision making and provide informed consent. That is, in the judgment of the examiner, the patient, after reading the IRB approved patient consent document (or having it read to them) can (a) generally understand the terms of participation in the study: the purpose of the study, what will be required of study participants; the potential risks, benefits and alternatives of study participation; pros \& cons of study involvement and (b) can communicate a choice in his/her own words (or write on a communication board)\]
• current significant cognitive impairment (≥3 errors on the Callahan cognitive status screen; see below)
• need for a translator because of poor English fluency \[many study instruments are not validated in other languages\]
• expected survival \<6 months per attending physician
• ICU length of stay \>30 days
• lack of either:
• reliable or sufficient smartphone with cellular data plan or
• reliable computer online access plus telephone access
• unable to complete study procedures as determined by study staff
• discharge to a location other than a home setting
• complex medical care expected soon after discharge (e.g., multiple planned surgeries, transplantation evaluation (including outpatient daily cardiopulmonary rehabilitation), extensive travel needs for hemodialysis, disruptive chemotherapy or XRT regimen, etc)

Sponsors & Collaborators

• Duke University: lead
• University of Washington: collaborator
• University of Pennsylvania: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

Duke University

Durham, North Carolina, 27710, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• Cox CE, Porter LS, Buck PJ, Hoffa M, Jones D, Walton B, Hough CL, Greeson JM. Development and preliminary evaluation of a telephone-based mindfulness training intervention for survivors of critical illness. Ann Am Thorac Soc. 2014 Feb;11(2):173-81. doi: 10.1513/AnnalsATS.201308-283OC.

  PMID: 24303911 BACKGROUND

• Cox CE, Hough CL, Jones DM, Ungar A, Reagan W, Key MD, Gremore T, Olsen MK, Sanders L, Greeson JM, Porter LS. Effects of mindfulness training programmes delivered by a self-directed mobile app and by telephone compared with an education programme for survivors of critical illness: a pilot randomised clinical trial. Thorax. 2019 Jan;74(1):33-42. doi: 10.1136/thoraxjnl-2017-211264. Epub 2018 May 23.

  PMID: 29793970 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic; Critical Illness

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Christopher Cox
• Organization: Duke University Health System

christopher.cox@duke.edu

9196817232

Study Officials

• Christopher E Cox, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 8, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: July 5, 2017
• Last Updated: February 7, 2018
• Results First Posted: January 10, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)