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N/A N=80 Randomized Single-blind Treatment

Mobile Mindfulness to Improve Psychological Distress After Critical Illness

Psychological Distress · Depression · Anxiety · Post-traumatic Stress Disorder · Informal Caregivers

Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Percent of Eligible Participants Who Provided Consent — 90 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
mobile mindfulness (Behavioral); standard mindfulness (Behavioral); education (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Duke University
Primary completion
May 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent of Eligible Participants Who Provided Consent
90
PRIMARY
Percent of Eligible Participants Who Provide Informed Consent and Were Randomized
80
PRIMARY
Client Satisfaction Questionnaire (CSQ) Score
27.6; 29.4; 25.7
PRIMARY
System Usability Scale (SUS)
86.5
PRIMARY
Percent of Randomized Participants Who Drop Out of Study
7; 2; 0; 2; 1; 2
PRIMARY
Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews
22; 28; 16
PRIMARY
Percent of Participants in the Self-directed MBT Group Who Complete Weekly Surveys
17
PRIMARY
Percentage of Self-directed MBT Sessions Attended by Eligible Participants
22
PRIMARY
Visual Analog Satisfaction Scale
PRIMARY
Number of Participant Clicks on Study Website
188.4
SECONDARY
Change in Psychological Distress Symptoms as Measured by the Patient Health Questionnaire (PHQ) Scale
-4.8; -3.9; -3.0
SECONDARY
Change in Distress Associated With Physical Symptoms
-5.3; -3.7; -4.8
SECONDARY
Change in Mindfulness Skills
0.7; -0.9; -1.3
SECONDARY
Change in Psychological Distress Symptoms as Measured by the GAD-7
-2.1; -1.6; -0.6
SECONDARY
Change in Psychological Distress Symptoms as Measured by the PTSS
-2.6; -2.2; -3.5
SECONDARY
Change in the Avoidance Domain of the Brief COPE Scale
-0.5; 1.3; -0.2

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.

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02701361). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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