Clinical trial NCT02701361: Mobile Mindfulness to Improve Psychological Distress After Critical Illness
Official title: Mobile Mindfulness to Improve Psychological Distress After Critical Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Depression
Anxiety
Post-traumatic Stress Disorder
Informal Caregivers
Family Members
Keywords: mindfulness
critical illness
intensive care unit
mindfulness-based stress reduction
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Washington
name: University of Pennsylvania
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2016-03-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria (the investigators will target patients at high risk for psychological distress):

* 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

Exclusion Criteria (present before consent): Patients will be excluded if they have characteristics that would prohibit adequate participation including:

* 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)

Other issues relevant to the consent process:

* unable to approach patient for logistical reasons (e.g., off ward in test at time of approach, etc)
* patient discharged before consent could be obtained
* patient dies before consent obtained

Patient exclusion criteria present after consent but before randomization:

After providing informed consent, patients will become ineligible if any of the following are present:

* they become too ill to participate (or die)
* they exhibit significant cognitive disability
* they exhibit suicidality
* patient was unexpectedly discharged to location other than a home setting and then did not arrive home within 1 month from hospital discharge

Primary outcomes:
measure: Percent of Eligible Participants Who Provided Consent
timeFrame: pre-randomization
measure: Percent of Eligible Participants Who Provide Informed Consent and Were Randomized
timeFrame: randomization
measure: Client Satisfaction Questionnaire (CSQ) Score
timeFrame: 1 month post-randomization
measure: System Usability Scale (SUS)
timeFrame: 1 month post-randomization
measure: Percent of Randomized Participants Who Drop Out of Study
timeFrame: baseline, end of study (approx. 4 months)
measure: Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews
timeFrame: baseline, end of study (approx. 4 months)
measure: Percent of Participants in the Self-directed MBT Group Who Complete Weekly Surveys
timeFrame: baseline, end of study (approx. 4 months)
measure: Percentage of Self-directed MBT Sessions Attended by Eligible Participants
timeFrame: baseline, end of study (approx. 4 months)
measure: Visual Analog Satisfaction Scale
timeFrame: after intervention completion, up to 8 weeks post-randomization
measure: Number of Participant Clicks on Study Website
timeFrame: baseline, end of study (approx. 4 months)
Secondary outcomes:
measure: Change in Psychological Distress Symptoms as Measured by the Patient Health Questionnaire (PHQ) Scale
timeFrame: Between randomization and 3 months post-randomization
measure: Change in Distress Associated With Physical Symptoms
timeFrame: Between randomization and 3 months post-randomization
measure: Change in Mindfulness Skills
timeFrame: Between randomization and 3 months post-randomization
measure: Change in Psychological Distress Symptoms as Measured by the GAD-7
timeFrame: Between randomization and 3 months post-randomization
measure: Change in Psychological Distress Symptoms as Measured by the PTSS
timeFrame: Between randomization and 3 months post-randomization
measure: Change in the Avoidance Domain of the Brief COPE Scale
timeFrame: Between randomization and 3 months post-randomization
Other outcomes:
measure: Usability Themes Developed From Semi-structured Participant Interviews
timeFrame: end of study
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Duke University
name: Christopher E Cox, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.