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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
January 1, 2019
Christopher E Cox et al. (11 authors)
Comparative StudyJournal ArticleMulticenter StudyRandomized Controlled TrialResearch Support, N.I.H., ExtramuralResearch Support, U.S. Gov't, Non-P.H.S.Human StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate the feasibility, acceptability, and usability of mobile and therapist-led mindfulness interventions for reducing psychological distress and physical symptoms in ICU survivors post-discharge.

Results Summary

The study found that both mobile and therapist-led mindfulness interventions were feasible, acceptable, and usable, with clinically significant improvements in depression, anxiety, PTSD, and physical symptoms, comparable to an education-based control.

Population

Adult ICU patients (≥18 years) treated for cardiorespiratory failure post-discharge.

Effective Dosage

Month-long interventions (self-directed mobile app-based mindfulness, therapist-led telephone-based mindfulness, or web-based critical illness education).

Duration

1 month

Interactions

None mentioned

Extracted Claims (14)
InterventionDirectionEndpointPopulationDosageImpactClaim #
self-directed mobile app-based mindfulness programme
neutral
feasibility, acceptability, usability
ICU patients
-
demonstrated evidence of feasibility, acceptability and usability
#1
self-directed mobile app-based mindfulness programme
decrease
psychological distress and physical symptoms
ICU patients
-
had a similar impact on psychological distress and physical symptoms as a therapist-led programme
#2
self-directed mobile app-based mindfulness programme
decrease
Patient Health Questionnaire depression scale
ICU patients
-4.8 (-6.6, -2.9)
reflected clinically significant group-based changes
#3
self-directed mobile app-based mindfulness programme
decrease
Generalized Anxiety Disorder scale
ICU patients
-2.1 (-3.7, -0.5)
reflected clinically significant group-based changes
#4
self-directed mobile app-based mindfulness programme
decrease
Post-Traumatic Stress Scale
ICU patients
-2.6 (-6.3, 1.2)
reflected clinically significant group-based changes
#5
self-directed mobile app-based mindfulness programme
decrease
Patient Health Questionnaire physical symptom scale
ICU patients
-5.3 (-7.0, -3.7)
reflected clinically significant group-based changes
#6
therapist-led telephone-based mindfulness programme
decrease
Patient Health Questionnaire depression scale
ICU patients
-3.9 (-5.6, -2.2)
reflected clinically significant group-based changes
#7
therapist-led telephone-based mindfulness programme
decrease
Generalized Anxiety Disorder scale
ICU patients
-1.6 (-3.0, -0.1)
reflected clinically significant group-based changes
#8
therapist-led telephone-based mindfulness programme
decrease
Post-Traumatic Stress Scale
ICU patients
-2.2 (-5.6, 1.2)
reflected clinically significant group-based changes
#9
therapist-led telephone-based mindfulness programme
decrease
Patient Health Questionnaire physical symptom scale
ICU patients
-3.7 (-5.2, 2.2)
reflected clinically significant group-based changes
#10
web-based critical illness education programme
decrease
Patient Health Questionnaire depression scale
ICU patients
-3.0 (-5.3, 0.8)
reflected clinically significant group-based changes
#11
web-based critical illness education programme
decrease
Generalized Anxiety Disorder scale
ICU patients
-0.6 (-2.5, 1.3)
reflected clinically significant group-based changes
#12
web-based critical illness education programme
decrease
Post-Traumatic Stress Scale
ICU patients
-3.5 (-8.0, 1.0)
reflected clinically significant group-based changes
#13
web-based critical illness education programme
decrease
Patient Health Questionnaire physical symptom scale
ICU patients
-4.8 (-6.8, 2.7)
reflected clinically significant group-based changes
#14
Abstract

BACKGROUND: Patients who are sick enough to be admitted to an intensive care unit (ICU) commonly experience symptoms of psychological distress after discharge, yet few effective therapies have been applied to meet their needs. METHODS: Pilot randomised clinical trial with 3-month follow-up conducted at two academic medical centres. Adult (≥18 years) ICU patients treated for cardiorespiratory failure were randomised after discharge home to 1 of 3 month-long interventions: a self-directed mobile app-based mindfulness programme; a therapist-led telephone-based mindfulness programme; or a web-based critical illness education programme. RESULTS: Among 80 patients allocated to mobile mindfulness (n=31), telephone mindfulness (n=31) or education (n=18), 66 (83%) completed the study. For the primary outcomes, target benchmarks were exceeded by observed rates for all participants for feasibility (consent 74%, randomisation 91%, retention 83%), acceptability (mean Client Satisfaction Questionnaire 27.6 (SD 3.8)) and usability (mean Systems Usability Score 89.1 (SD 11.5)). For secondary outcomes, mean values (and 95% CIs) reflected clinically significant group-based changes on the Patient Health Questionnaire depression scale (mobile (-4.8 (-6.6, -2.9)), telephone (-3.9 (-5.6, -2.2)), education (-3.0 (-5.3, 0.8)); the Generalized Anxiety Disorder scale (mobile -2.1 (-3.7, -0.5), telephone -1.6 (-3.0, -0.1), education -0.6 (-2.5, 1.3)); the Post-Traumatic Stress Scale (mobile -2.6 (-6.3, 1.2), telephone -2.2 (-5.6, 1.2), education -3.5 (-8.0, 1.0)); and the Patient Health Questionnaire physical symptom scale (mobile -5.3 (-7.0, -3.7), telephone -3.7 (-5.2, 2.2), education -4.8 (-6.8, 2.7)). CONCLUSIONS: Among ICU patients, a mobile mindfulness app initiated after hospital discharge demonstrated evidence of feasibility, acceptability and usability and had a similar impact on psychological distress and physical symptoms as a therapist-led programme. A larger trial is warranted to formally test the efficacy of this approach. TRIAL REGISTRATION NUMBER: Results, NCT02701361.

Medical Subject Headings (MeSH)
AdultAgedAnxietyCritical IllnessDepressionFeasibility StudiesFemaleHeart FailureHumansMaleMiddle AgedMindfulnessMobile ApplicationsPatient Acceptance of Health CarePatient Education as TopicPatient SatisfactionPilot ProjectsPsychiatric Status Rating ScalesRespiratory InsufficiencyStress Disorders, Post-TraumaticSurvivorsTelephone
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality80/10
Citation Metrics
Total Citations45
Citations/Year7.5
Relative Citation Ratio3.34
NIH Percentile87.1%
Research Impact Scores
APT Score0.95
Weight Score2.41
Normalized Score0.66
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