Cited by 102Mindfulness and Compassion InterventionsDigital Mental Health InterventionsIntensive Care Unit Cognitive Disorders

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

Open access
Cox, Christopher E, Hough, Catherine L, Jones, Derek M, Ungar, Anna, Reagan, Wen, Key, Mary D, Gremore, Tina, Olsen, Maren K +3 more·2019·Thorax

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 (â '4.8 (â 6.6, â 2.9)), telephone (â 3.9 (â 5.6, â 2.2)), education (â 3.0 (â 5.3, 0.8)); the Generalized Anxiety Disorder scale (mobile â 2.1 (â 3.7, â 0.5), telephone â '1.6 (â '3.0, â '0.1), education â '0.6 (â '2.5, 1.3)); the Post-Traumatic Stress Scale (mobile â '2.6 (â '6.3, 1.2), telephone â '2.2 (â '5.6, 1.2), education â '3.5 (â '8.0, 1.0)); and the Patient Health Questionnaire physical symptom scale (mobile â '5.3 (â '7.0, â '3.7), telephone â '3.7 (â '5.2, 2.2), education â '4.8 (â '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. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved.

Integrity signals

Registry

Crossref · 10.1136/thoraxjnl-2017-211264

Cites

43 of 43 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

10 of 25 cited sources checked · 2 supported · 0 flagged · accuracy not yet measured

  • Premisecitation

    Patients admitted to an intensive care unit commonly experience psychological distress after discharge.

    “Patients who are sick enough to be admitted to an intensive care unit (ICU) commonly experience symptoms of psychological distress after discharge”
    • Also stated in: § INTRODUCTION · plain
      “millions of patients who require treatment in intensive care units (ICUs) are left not only with physical symptoms,1–3 but with psychological long-term distress.4”
    Quote in the paperSubstantial claim2 of 4 sources checked
    • cites [1] source

      The Results (The day to day impact of new disability) report depression, anxiety, fear, and emotional lability after discharge, and the Discussion describes patients’ psychological distress. However, the Methods (Study design) show that the study enrolled ARDS survivors who required mechanical ventilation, so its findings do not establish how commonly psychological distress occurs among all ICU patients. (LLM, conf=0.84)

      Experimental — accuracy not yet measured
    • cites [2] source
    • cites [3] source
    • cites [4] source

      The Introduction (page unavailable) says ARDS survivors frequently experience persistent mental-health impairments, including anxiety, after discharge. This supports the claim for ARDS survivors, but the source does not establish how common psychological distress is among ICU patients generally. (LLM, conf=0.86)

      Experimental — accuracy not yet measured
  • Premisecitation

    Standard mindfulness training has proven efficacious in improving psychological distress in medical patient populations such as cancer, cardiovascular disease, and chronic pain.

    “Standard mindfulness training, typically provided face to face in group settings, has proven efficacious in improving psychological distress in various medical patient populations such as cancer, cardiovascular disease, and chronic pain.1314”
    Quote in the paperNot a substantial claim1 of 2 sources checked
    • cites [13] source
    • cites [14] Gotink RA , Chu P , Busschbach JJ , et al . Standardised mindfulness-based interventions in healthcare: an overview of systematic reviews and meta-analyses of RCTs. PLoS One 2015;10:e0124344.doi:10.1371/journal.pone.0124344 source
  • Interpretationown data

    The data linking frequency, quality, and duration of app use with reduction in depression symptoms demonstrate the importance of optimizing user engagement.

    “Our data closely linking the frequency, quality, and duration of app use with reduction in depression symptoms demonstrates the importance of optimizing user engagement as a means to improve adherence, retention, dose, and effect.3738”
    Quote in the paperSubstantial claim1 of 2 sources checked
    • cites [37] Services DoHaH. Research-based web design & usability guidelines, 2013.

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [38] source

      The Discussion (Principal Findings; page unavailable) says that time spent practicing has a dose–response relationship with improvement and that poor adherence can hamper the effectiveness of Web-based mindfulness interventions. It supports the general rationale for engagement, but does not report the citing authors’ data linking the frequency, quality, and duration of app use specifically to reduced depressive symptoms. (LLM, conf=0.83)

      Experimental — accuracy not yet measured
  • Findingown data

    Mean System Usability Scale score was 86.5 (SD 13.3), demonstrating strong usability.

    “Mean CSQ (27.6 [SD 3.8]) and SUS (86.5 [SD 13.3]) scores demonstrated strong acceptability and usability”
    Quote in the paperSubstantial claim
  • Findingown data

    Depression symptom improvement had a stronger correlation with activity in later intervention stages than in earlier stages.

    “Depression symptom improvement had a stronger correlation with activity in the later stages of the intervention (r=−0.42 [week 4]) compared to earlier stages (r = 0.02 [week 1]).”
    Quote in the paperNot a substantial claim
  • Classified as probably not a substantial claim. 7
  • May combine two claims. 21
  • The quote only partly states this claim. 1
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    As many as 66% of acute respiratory distress syndrome survivors report clinically important depression, anxiety, and PTSD symptoms at 1 year post-discharge.

    “As many as 66% of acute respiratory distress syndrome (ARDS) survivors report clinically important symptoms of depression, anxiety, and post-traumatic stress disorder (PTSD) at 1 year post-discharge.5–8”
    Quote in the paperNot a substantial claim4 of 4 sources checked
    • cites [5] Huang, 2016, Psychiatric Symptoms in Acute Respiratory Distress Syndrome Survivors: A 1-Year National Multicenter Study, Crit Care Med source

      The Results (Individual Psychiatric Domains and their Co-occurrence) report that 416 of 629 survivors (66%) had substantial symptoms in at least one of the three domains during one-year follow-up, not specifically at the 12-month assessment. The same section reports 53% with symptoms in at least one domain at six months and says results were similar at 12 months. Thus the source supports the symptom types and 66% figure, but not the claim's single-time-point framing. (LLM, conf=0.90)

      Experimental — accuracy not yet measured
    • cites [6] Bienvenu, 2015, Cooccurrence of and remission from general anxiety, depression, and posttraumatic stress disorder symptoms after acute lung injury: a 2-year longitudinal study, Crit Care Med source

      The Abstract (Measurements and Main Results) reports substantial anxiety, depression, and PTSD symptoms among acute lung injury survivors, with more than half having symptoms in at least one domain during two-year follow-up. It does not report 66% at one year. The Study population section also dates the 12-month assessment from the onset of lung injury, not hospital discharge. (LLM, conf=0.87)

      Experimental — accuracy not yet measured
    • cites [7] source

      The Discussion reports clinically important depressive symptoms in about 30% of general ICU survivors during the first 12 months after discharge, and the Results report correlations with anxiety and PTSD symptoms. Neither passage establishes the claimed 66% prevalence for ARDS survivors at one year; the paper cites an ARDS-specific study in its References but does not report that figure here. (LLM, conf=0.85)

      Experimental — accuracy not yet measured
    • cites [8] Jackson, 2014, Depression, post-traumatic stress disorder, and functional disability in survivors of critical illness in the BRAIN-ICU study: a longitudinal cohort study, Lancet Respir Med source

      The Mental Health Outcomes sections (page not provided) report depressive symptoms in 33% and probable PTSD in 7% of respondents at 12 months. This supports the presence of those symptoms after critical illness, but the study reports results for a general ICU cohort, not specifically ARDS survivors; it does not report anxiety or a 66% prevalence for the claimed combination. (LLM, conf=0.87)

      Experimental — accuracy not yet measured
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    The study's methods and reporting were guided by the 2016 CONSORT extension for randomized pilot and feasibility trials.

    “Study methodologies and reporting are guided by the 2016 CONSORT statement extension to randomized pilot and feasibility trials.18”
    Quote in the paperNot a substantial claim1 of 1 sources checked
  • May combine two claims.

    Study design and conductown data

    The full cohort had mild baseline depression and anxiety symptoms and mild to moderate PTSD symptoms, which did not differ by group assignment.

    “The full cohort demonstrated mild baseline symptoms of depression and anxiety, as well as mild to moderate PTSD symptoms that did not differ by group assignment (Table 3; see also Online Supplement eTables 5 and 6).31”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [31] Black, 2015, Mindfulness meditation and improvement in sleep quality and daytime impairment among older adults with sleep disturbances: a randomized clinical trial, JAMA Intern Med source

      The Results, “Participant Flow and Characteristics” (page unavailable), reports nonclinical baseline depression and anxiety scores and says baseline variables did not differ between treatment groups. It does not report PTSD symptoms or establish their severity or similarity across groups. (LLM, conf=0.88)

      Experimental — accuracy not yet measured
  • May combine two claims.

    Findingnone given

    The CAMS-R and Brief COPE did not appear responsive to change.

    “The CAMS-R and Brief COPE did not appear responsive to change.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    27 (93%) telephone and 17 (94%) education patients completed all intervention sessions.

    “Similarly, 27 (93%) of telephone and 17 (94%) of education patients completed all intervention sessions.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    Post-randomization dropout was higher in the mobile mindfulness group, but most occurred before patients had contact with study staff or used the app.

    “Third, though post-randomization dropout was higher in the mobile mindfulness group, most of it occurred before patients either had contact with study staff or used the app.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    Of 121 potentially eligible patients, 90 provided informed consent and 80 were randomized after discharge home to mobile mindfulness, telephone mindfulness, or education.

    “Of 121 potentially eligible patients, 90 provided informed consent during hospitalization and 80 were randomized (Site 1 n=48, 60%; Site 2 n=32, 40%) after discharge home to mobile mindfulness (n=31, 39%), telephone mindfulness (n=31, 39%), and education (n=18, 22%) (Figure 1).”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    Education recipients had numerically less improvement on PHQ-9 and GAD-7 than mindfulness groups, but similar changes on PTSS.

    “Among education recipients in comparison to the mindfulness groups, there was numerically less impact seen on PHQ-9 (−3.0 [−5.3, −0.8]) and GAD-7 (−0.6 [−2.5,1.3]) scores at 3 months, though similar changes on the PTSS score (−3.5 [−8.0, 1.0]).”
    Quote in the paperNot a substantial claim
  • The quote only partly states this claim.

    Findingown data

    The similar impact between mobile and telephone mindfulness was consistent across GAD-7, PTSS, and PHQ-15 measures.

    “This similar impact was consistent across the GAD-7 (mobile mindfulness −2.1 [−3.7, −0.5]; telephone −1.6 [−3.0, −0.1]), PTSS (mobile mindfulness −2.6 [−6.3, 1.2]; telephone −2.2 [−5.6, 1.2]), and PHQ-10 (mobile mindfulness −5.3 [−7.0, −3.7]; telephone −3.7 [−5.2, −2.2]); see also Online Supplement 2 eFigure 1.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    Feasibility benchmarks were exceeded: consent 74%, randomization 91%, and retention 83%.

    “target benchmarks were exceeded by observed rates for all participants for feasibility (consent 74%, randomization 91%, retention 83%)”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    Among 24 mobile mindfulness patients who initiated the app, 93 of 96 possible weekly app sessions were completed, and 22 completed all 4 app sessions and all 4 weekly surveys.

    “Among the 24 mobile mindfulness patients who initiated the app, 93 of 96 (97%) possible weekly app sessions were completed; 22 (92%) completed all 4 app sessions and all 4 weekly surveys as determined by app analytics.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingown data

    A total of 66 randomized patients completed the study, representing 83% overall and 89% of those with any post-discharge contact with study staff.

    “A total of 66 randomized patients completed the study, representing 83% overall and 89% of those with any post-discharge contact with study staff.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Findingnone given

    The education group had a lower prevalence of shock and ARDS and returned to normal duties over two weeks earlier than the mobile mindfulness group.

    “Furthermore, despite less improvement in distress compared to the mobile mindfulness group, the education group had a lower prevalence of shock and ARDS and returned to normal duties over two weeks earlier.”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Findingown data

    Depression symptom improvement correlated with number of pages viewed per session, screen clicks per session, and app sessions viewed overall.

    “For example, depression symptom improvement (i.e., PHQ-9 score change) was correlated with number of pages viewed per session (r=−0.54), number of screen clicks per app session (r=−0.49), and number of app sessions viewed overall (r=−0.46).”
    Quote in the paperNot a substantial claim
  • May combine two claims.

    Interpretationown data

    A self-directed, four-session post-discharge mindfulness program for ICU survivors delivered by a mobile app was feasible, acceptable, usable, and demonstrated evidence for impact on psychological distress similar to a therapist-delivered mindfulness program.

    “A self-directed, four-session post-discharge mindfulness program for ICU survivors delivered by a mobile app was feasible, acceptable, usable, and demonstrated evidence for impact on psychological distress that was similar to a therapist-delivered mindfulness program.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Study design and conductreasoning

    The small sample limits the precision and generalizability of results and the ability to understand the impact of clinical and demographic variables.

    “First, the small sample limits the precision and the generalizability of results as well as our ability to understand the impact of clinical and demographic variables.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Study design and conductreasoning

    The sample size of 90 was pragmatic and not based on formal power calculations.

    “A pragmatic sample size of 90 was chosen not based on formal power calculations, but rather because it represented a cohort large enough to inform the investigators about the potential challenges of delivering an app-based intervention in the context of post-discharge care.”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim.

    Study design and conductnone given

    This pilot study was not designed to evaluate efficacy.

    “Second, while the results are compelling, this pilot study was not designed to evaluate efficacy.”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim. May combine two claims.

    Study design and conductnone given

    All participant data collected were included in models and analyzed according to original group allocation.

    “All participant data collected were included in models and analyzed according to the original group allocation.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Interpretationown data

    Mobile mindfulness performed similarly to therapist-led mindfulness and generally better than an education program.

    “Importantly, mobile mindfulness performed similarly to therapist-led mindfulness training program and generally better than an education program.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Interpretationreasoning

    Mobile mindfulness appears promising as a scalable patient-centered approach to addressing ICU survivors' psychological distress and overcoming post-discharge access barriers.

    “Mobile mindfulness therefore appears to show promise as a scalable patient-centered approach to addressing ICU survivors’ widely prevalent psychological distress that can also overcome many post-discharge access to care barriers these patients experience.”
    Quote in the paperSubstantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    An independent data safety monitoring board approved the protocol and reviewed safety every 6 months.

    “An independent data safety monitoring board approved the protocol and reviewed safety at 6-month intervals.”
    Quote in the paperNot a substantial claim
  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    A computer algorithm allocated participants at a 1.75:1.75:1 ratio using simple randomization for the first 18 participants and then dynamic allocation via minimization to balance across specified strata.

    “A computer algorithm allocated participants at a 1.75:1.75:1 ratio (mobile, telephone, education) using simple randomization for the first 18 participants and then dynamic allocation via a method of minimization approach 19 to ensure balance across strata including: baseline Patient Health Questionnaire 9-item depression scale (PHQ-9) score (<15 vs. ≥15; representing a cutoff of ‘moderately severe”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [19] source
  • May combine two claims.

    Interpretationown data

    In this multicenter pilot RCT, mobile mindfulness was supported for feasibility, acceptability, usability, and impact on psychological distress.

    “In this multicenter pilot RCT, we found support for the feasibility, acceptability, usability, and impact on psychological distress of a novel self-directed mindfulness training program delivered by a mobile app.”
    Quote in the paperSubstantial claim
  • May combine two claims.

    Interpretationcitation

    Self-directed mobile mindfulness had a favorable effect on symptoms, which is uncommon for a comparative web-based therapy.

    “Second, while the self-directed mobile mindfulness had a favorable effect on symptoms, uncommon for a comparative web-based therapy,3739 the telephone group had slightly better adherence and retention.”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [37] Services DoHaH. Research-based web design & usability guidelines, 2013.

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

    • cites [39] source
  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The institutional review boards of the participating sites approved the study protocol.

    “The institutional review boards of the participating sites approved the study protocol (Online Supplement 1).”
    Quote in the paperNot a substantial claim
26 of 26

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Education group PHQ-15 confidence interval is inconsistent

    Major

    The reported 95% CI for the education group's PHQ-15 change excludes the point estimate on the lower side. The interval and estimate do not match each other as written.

    Reported 2.7 · recomputed -2

  • Telephone PHQ-15 confidence interval is inconsistent

    Major

    The telephone group's PHQ-15 interval has an upper bound that is higher than the point estimate by 5.9, but elsewhere the same result is reported with a different upper bound. The interval as printed here conflicts with the corresponding results section.

    Reported 2.2 · recomputed 5.9

  • Usability scores differ between the abstract and results

    Major

    The abstract reports a mean usability score of 89.1 with an SD of 11.5, while the results report 86.5 with an SD of 13.3.

  • Education-group depression interval changes sign

    Major

    The abstract gives 0.8 as the upper confidence limit for the education group's depression change; the results give −0.8. The discrepancy changes whether the interval includes zero.

  • Telephone-group physical-symptom interval changes sign

    Major

    The abstract gives 2.2 as the upper confidence limit for the telephone group's physical-symptom change; the results give −2.2. The discrepancy changes whether the interval includes zero.

  • Physical-symptom scale is named inconsistently

    Minor

    The results label the measure accompanying the physical-symptom changes as PHQ-10, whereas the methods identify the physical-symptom measure as PHQ-15.

6 of 6

Cited works that were retracted

Works this paper cites that were later retracted, from the retraction notices publishers deposit. Major when the notice came out before this paper was published.

  • Cites a retracted work: 10.1371/journal.pone.0124344

    Info

    The cited work was retracted on 2019-04-12 (notice 10.1371/journal.pone.0215608), not before this paper was published (2018-05-23).

    Cited work 10.1371/journal.pone.0124344 · retracted 2019-04-12 · notice 10.1371/journal.pone.0215608 · this paper published 2018-05-23

1 of 1

Cites

1 retracted

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Cited by

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Authors
Cox, C. E., Hough, C. L., Jones, D. M., Ungar, A., Reagan, W., Key, M. D., Gremore, T., Olsen, M. K., Sanders, L., Greeson, J. M., & Porter, L. S.
Affiliations
  • Duke University (US)
  • University of Washington (US)
  • Rowan University (US)
Corresponding author
Cox, Christopher E
Venue
Thorax
Publisher
BMJ
Published
2018-05-23
Volume
74
Issue
1
Pages
33-42
ISSN
  • 0040-6376 (ISSN-L)
  • 1468-3296
OpenAlex
W2803399833
Cited by
102
References
43
Citations by year
2026: 12 · 2025: 12 · 2024: 10 · 2023: 25 · 2022: 10 · 2021: 9 · 2020: 12 · 2019: 8 · 2018: 4
FWCI
9.67
Type
journal article
Language
en
Open access
Locations
  • Thorax (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
  • HighWire Press Open Archive (submittedVersion)
Funders
National Center for Complementary and Integrative Health
Topics
  • Social Sciences › Psychology › Clinical Psychology › Mindfulness and Compassion Interventions
  • Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
  • Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Intensive Care Unit Cognitive Disorders
Keywords
mindfulness training, intensive care unit survivors, critical illness, mobile health apps, telephone-delivered intervention, psychological distress, depression, anxiety, post-traumatic stress, somatic symptoms, feasibility and acceptability, cardiopulmonary failure, hospital discharge, post-discharge care, self-guided intervention, patient satisfaction, usability, post-ICU rehabilitation
MeSH terms
Adult, Aged, Anxiety, Depression, Feasibility Studies, Female, Heart Failure, Humans, Male, Middle Aged, Patient Acceptance of Health Care, Patient Education as Topic, Pilot Projects, Psychiatric Status Rating Scales, Respiratory Insufficiency, Stress Disorders, Post-Traumatic, Telephone, Critical Illness, Patient Satisfaction, Survivors, Mobile Applications, Mindfulness

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