Cardiorespiratory FailureLIFT2NCT04038567
Optimizing a Mobile Mindfulness Intervention for ICU Survivors
A study testing Mobile mindfulness-based training in people with Cardiorespiratory Failure, run by Duke University at 3 sites in United States.
Trial summary
This is a factorial experimental trial involving adult survivors of cardiorespiratory failure treated in intensive care units (ICUs) that is conceptualized as the Optimization Phase of a multiphase optimization strategy (MOST) framework. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiorespiratory Failure
- What is being tested?
- Mobile mindfulness-based training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Aug 2019to 19 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age ≥18)
- Acute cardiorespiratory failure:
- Acute respiratory failure, defined as ≥1 of the following:
- 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 oxygen for ≥4 hours in a 24-hour period and / or
Show all 21Show fewer
- Acute cardiac / circulatory failure, defined as ≥1 of the following:
- use of vasopressors for shock of any etiology for ≥1 hour
- use of inotropes for shock of any etiology for ≥1 hour
- use of pulmonary vascular vasoactive medications
- use of aortic balloon pump for cardiogenic shock for ≥1 hour
- Managed in an adult medical cardiac, trauma, surgical, or neurological ICU, stepdown unit, or monitored ward unit for ≥24 hours during the time inclusion criterion #2 is met.
- Cognitive status intact
- No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart
- Absence of current significant cognitive impairment (impairment defined as ≥3 errors on the Callahan cognitive status screen)
- Decisional capacity present
- Absence of severe and/or persistent mental illness
- Treatment for severe and/or persistent mental illness (e.g., psychosis, bipolar affective disorder, schizoaffective disorder, schizoid personality disorder, schizophrenia [as per medical record], hospitalization for any psychiatric disorder) within the 6 months preceding the current hospital admission
- No endorsement of suicidality at time of admission or informed consent
- No active substance abuse within the 3 months preceding the current admission serious enough to limit completion of study procedures in the opinion of the site investigator.
- English fluency.
Who cannot join
- Hospitalized within the preceding 3 months with life-threatening illness or injury.
- Patients may be enrolled into the study if they had a hospitalization within the preceding 3 months that is determined to be non-serious. Non-serious admissions are defined as those admissions that are non-life threatening and/or potentially impacting patient's well-being long-term or likely to precipitate additional future admissions. Examples of non-life-threatening hospitalizations could be, but may not be limited to, admission for a bronchoscopy, admission for deep vein thrombosis, or admission to ED resulting in overnight stay for cardiac work-up.
- Admitted from a location other than home (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility)
- Anticipated or actual discharge to a location other than independent in a home setting (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility, home hospice)
- Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for hemodialysis, disruptive chemotherapy/radiation regimen)
- Unable to complete study procedures as determined by staff
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- Lack of reliable smartphone with cellular data plan or wifi access
- Low baseline psychological distress symptoms, defined as the absence of the following at T1: PHQ-9 score <5
- Failure to randomize within 2 month (60 days) post-discharge.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado - Denver
Aurora, Colorado, 80045
Duke University Medical Center
Durham, North Carolina, 27710
University of Washington
Seattle, Washington, 98195
About this study
Official title: Optimizing a Self-directed Mobile Mindfulness Intervention for Improving Cardiorespiratory Failure Survivors' Psychological Distress
This is a factorial experimental trial involving adult survivors of cardiorespiratory failure treated in intensive care units (ICUs) that is conceptualized as the Optimization Phase of a multiphase optimization strategy (MOST) framework. This will allow optimization of a mobile mindfulness intervention by comparing eight different iterations across domains including impact on symptoms, feasibility, acceptability, usability, scalability, and cost.
Read the detailed description
As survival has improved for the 2 million people with cardiorespiratory failure managed annually in US intensive care units (ICUs), it has become apparent that these patients suffer from severe and persistent post-discharge symptoms of psychological distress including depression, anxiety, and post-traumatic stress disorder (PTSD). However, few targeted interventions exist that are relevant to patients' experiences and that accommodate their many physical, social, and financial barriers to personalized care. To fill this gap, an innovative app-based mobile mindfulness training program twas developed hat promotes automated care delivery and self-management of symptom-related distress.
Subsequently, a pilot randomized clinical trial (RCT) called the LIFT study (R34 AT00819) compared mobile mindfulness to both a standard telephone mindfulness program and an ICU education control among survivors of cardiorespiratory failure. Key findings were that mobile mindfulness was feasibly delivered, acceptable, usable, and had a greater clinical impact on psychological distress than either comparator. This trial also highlighted opportunities to improve the intervention's impact related to its targeted population, content delivery, and system technology.
To address these gaps, this 5-year project is conceptualized as the Optimization Phase of a multiphase optimization strategy (MOST) framework. It will optimize mobile mindfulness with four specific aims as described in the following sections. At the conclusion of this factorial randomized clinical trial study involving 240 cardiorespiratory failure survivors, a mobile mindfulness system fully optimized for usability, efficiency, scalability, and clinical impact will be delivered that will be off-the-shelf ready for a next-step definitive RCT-and can serve as a model for distance-based mind and body interventions.
- Conditions
- Cardiorespiratory Failure
- Being tested
- Mobile mindfulness-based training
- Keywords
- cardiorespiratory failure, critical illness, psychological distress, depression, anxiety, post-traumatic stress disorder, intensive care units, adults, mechanical ventilation
- Medical subject headings
- Critical Illness, Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile mindfulness-based trainingBehavioural
The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 6 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.
| Study group | Role | What they receive |
|---|---|---|
| App introduction to intervention | Other | Introduction to intervention via the mobile app itself. Receives: Behavioral: Mobile mindfulness-based training |
| Therapist introduction to intervention | Other | Introduction to intervention via a call from the study therapist. Receives: Behavioral: Mobile mindfulness-based training |
| Standard dose | Other | Standard dose of meditation time (once a day). Receives: Behavioral: Mobile mindfulness-based training |
| High dose | Other | High dose of meditation time (twice a day). Receives: Behavioral: Mobile mindfulness-based training |
| App response to symptoms | Other | Mobile app response to elevated psychological distress symptoms during intervention period. Receives: Behavioral: Mobile mindfulness-based training |
| Therapist response to symptoms | Other | Therapist call in response to elevated psychological distress symptoms during intervention period. Receives: Behavioral: Mobile mindfulness-based training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 Item Scale (PHQ-9)
Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse)
Measured: 1 month post-randomization
Secondary outcomes (23)
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Absolute values, not change scores. Anxiety symptoms. Scores range from 0 (better) to 21 (worse)
Measured: Between baseline 1 month post-randomization
Patient Health Questionnaire-9 Item Scale (PHQ-9)
Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse)
Measured: Between baseline 3 months post-randomization
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Absolute values, not change scores. Anxiety symptoms. Scores range from 0 (better) to 21 (worse)
Measured: Between baseline 3 months post-randomization
Post-Traumatic Stress Symptom Inventory (PTSS)
Absolute values, not change scores. PTSD symptoms. Scores can range from 10 (best) to 70 (worst).
Measured: Between baseline 3 months post-randomization
Intervention Adherence: Activity in App During Final Week of Intervention
Quantified by number with activity (or not) in app during final week (4) of intervention
Measured: 1 month post-randomization
Intervention Adherence: Number of Views of Content
Quantified by mean (SD) number of intervention content (audio, video, text) views
Measured: 1 month post-randomization
Client Satisfaction Questionnaire (CSQ)
A measure of acceptability. Scores can range from 8 (worst) to 32 (best)
Measured: 3 months post-randomization
Systems Usability Scale (SUS)
A measure of intervention usability. Each of 10 items is scored from 1 to 5. For each of the odd numbered questions, subtract 1 from the score.
For each of the even numbered questions, subtract their value from 5. Take these new values and add up the total score. Then multiply this by 2.5.Scores can range from 0 (worst) to 100 (best)
Measured: 3 months post-randomization
Mindful Attention Awareness Scale (MAAS)
This is the absolute value, not change score. A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best).
Measured: Between baseline and 1 month post-randomization
Mindful Attention Awareness Scale (MAAS)
These are absolute values, not change scores. A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best).
Measured: Between baseline 3 months post-randomization
Patient Health Questionnaire 10-item Scale (PHQ-10)
These are absolute values, not change scores. An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst).
Measured: Between baseline and 1 month post-randomization
Patient Health Questionnaire 10-item Scale (PHQ-10)
This is an absolute value, not a change score. An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst).
Measured: Between baseline 3 months post-randomization
EuroQOL Scale
This is an absolute, not change, value. the EuroQOL is a measure of quality of life. Scores can range from 0 (worst) to 100 (best)
Measured: Between baseline and 1 month post-randomization
Change in EuroQOL Scale
A measure of quality of life. Scores can range from 0 (worst) to 100 (best)
Measured: Between baseline 3 months post-randomization
Distress Associated With Depression Symptom Frequency
A visual analog scale appended to the PHQ-9 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PHQ-9. Scores range from 0 (best) to 100 (worst)
Measured: Between baseline and 1 month post-randomization; THIS WAS NOT RECORDED
Distress Associated With Depression Symptom Frequency
A visual analog scale appended to the PHQ-9 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PHQ-9. Scores range from 0 (best) to 100 (worst)
Measured: At 1 month post-randomization
Distress Associated With Anxiety Symptom Frequency
A visual analog scale appended to the GAD-7 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the GAD-7. Scores range from 0 (best) to 100 (worst)
Measured: At 1 month post-randomization
Distress Associated With Anxiety Symptom Frequency
A visual analog scale appended to the GAD-7 which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the GAD-7. Scores range from 0 (best) to 100 (worst)
Measured: Between baseline 3 months post-randomization
Distress Associated With PTSD Symptom Frequency
A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst)
Measured: At 1 month post-randomization
Distress Associated With PTSD Symptom Frequency
Absolute values, not change scores. A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst)
Measured: At 3 months post-randomization
Post-Traumatic Stress Symptom Inventory (PTSS)
Absolute values, not change scores. Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst).
Measured: Between baseline and 1 month post-randomization
Client Satisfaction Questionnaire (CSQ)
A measure of acceptability. Scores can range from 8 (worst) to 32 (best)
Measured: 1 month post-randomization
Systems Usability Scale (SUS)
A measure of intervention usability. Each of 10 items is scored from 1 to 5. For each of the odd numbered questions, subtract 1 from the score.
For each of the even numbered questions, subtract their value from 5. Take these new values and add up the total score. Then multiply this by 2.5.Scores can range from 0 (worst) to 100 (best)
Measured: 1 month post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start15 Aug 2019
- Primary completion1 May 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiorespiratory FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Factorial experimental trial as part of a multi-phase optimization strategy (MOST) design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, University of Colorado, Denver, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Christopher E Cox, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038567
- Sponsor's protocol ID
- Pro00100252
- Other IDs
- 1U01AT009974
- Acronym
- LIFT2
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2019
- Last updated
- 15 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will follow NIH/NCCIH guidelines for data access.
Publications
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.
PubMed 24303911Cox 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.
PubMed 29793970Cox CE, Olsen MK, Gallis JA, Porter LS, Greeson JM, Gremore T, Frear A, Ungar A, McKeehan J, McDowell B, McDaniel H, Moss M, Hough CL. Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial. Contemp Clin Trials. 2020 Sep;96:106119. doi: 10.1016/j.cct.2020.106119. Epub 2020 Aug 15.
PubMed 32805434Shubert I, Poehlein E, Ashana DC, Kuchibhatla M, Gallis JA, Olsen MK, Porter LS, Moss M, Hough CL, Cox CE. Predictive Utility of In-Hospital Screening for Postdischarge Depression Symptoms Among Survivors of Critical Illness. CHEST Crit Care. 2026 Sep;4(3):100279. doi: 10.1016/j.chstcc.2026.100279. Epub 2026 May 15.
PubMed 42769870Cox CE, Gallis JA, Olsen MK, Porter LS, Gremore T, Greeson JM, Morris C, Moss M, Hough CL. Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors: A Randomized Clinical Trial. JAMA Intern Med. 2024 Jul 1;184(7):749-759. doi: 10.1001/jamainternmed.2024.0823.
PubMed 38805199
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Self-directed Mobile Mindfulness Intervention for Improving Cardiorespiratory Failure Survivors' Psychological Distress
- ClinicalTrials.gov ID
- NCT04038567
- Acronym / sponsor ID
- LIFT2 / Pro00100252
- Conditions
- Cardiorespiratory Failure
- Keywords
- cardiorespiratory failure, critical illness, psychological distress, depression, anxiety, post-traumatic stress disorder, intensive care units, adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of Washington, University of Colorado, Denver, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Posted 15 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a factorial experimental trial involving adult survivors of cardiorespiratory failure treated in intensive care units (ICUs) that is conceptualized as the Optimization Phase of a multiphase optimization strategy (MOST) framework. This will allow optimization of a mobile mindfulness intervention by comparing eight different iterations across domains including impact on symptoms, feasibility, acceptability, usability, scalability, and cost.
Detailed description
As survival has improved for the 2 million people with cardiorespiratory failure managed annually in US intensive care units (ICUs), it has become apparent that these patients suffer from severe and persistent post-discharge symptoms of psychological distress including depression, anxiety, and post-traumatic stress disorder (PTSD). However, few targeted interventions exist that are relevant to patients' experiences and that accommodate their many physical, social, and financial barriers to personalized care. To fill this gap, an innovative app-based mobile mindfulness training program twas developed hat promotes automated care delivery and self-management of symptom-related distress.
Subsequently, a pilot randomized clinical trial (RCT) called the LIFT study (R34 AT00819) compared mobile mindfulness to both a standard telephone mindfulness program and an ICU education control among survivors of cardiorespiratory failure. Key findings were that mobile mindfulness was feasibly delivered, acceptable, usable, and had a greater clinical impact on psychological distress than either comparator. This trial also highlighted opportunities to improve the intervention's impact related to its targeted population, content delivery, and system technology.
To address these gaps, this 5-year project is conceptualized as the Optimization Phase of a multiphase optimization strategy (MOST) framework. It will optimize mobile mindfulness with four specific aims as described in the following sections. At the conclusion of this factorial randomized clinical trial study involving 240 cardiorespiratory failure survivors, a mobile mindfulness system fully optimized for usability, efficiency, scalability, and clinical impact will be delivered that will be off-the-shelf ready for a next-step definitive RCT-and can serve as a model for distance-based mind and body interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Factorial experimental trial as part of a multi-phase optimization strategy (MOST) design
| Arm | Type | Receives |
|---|---|---|
| App introduction to intervention | Other | Behavioral: Mobile mindfulness-based trainingIntroduction to intervention via the mobile app itself. |
| Therapist introduction to intervention | Other | Behavioral: Mobile mindfulness-based trainingIntroduction to intervention via a call from the study therapist. |
| Standard dose | Other | Behavioral: Mobile mindfulness-based trainingStandard dose of meditation time (once a day). |
| High dose | Other | Behavioral: Mobile mindfulness-based trainingHigh dose of meditation time (twice a day). |
| App response to symptoms | Other | Behavioral: Mobile mindfulness-based trainingMobile app response to elevated psychological distress symptoms during intervention period. |
| Therapist response to symptoms | Other | Behavioral: Mobile mindfulness-based trainingTherapist call in response to elevated psychological distress symptoms during intervention period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Adult (age ≥18)
- Acute cardiorespiratory failure:
- Managed in an adult medical cardiac, trauma, surgical, or neurological ICU, stepdown unit, or monitored ward unit for ≥24 hours during the time inclusion criterion #2 is met.
- Cognitive status intact
- Absence of severe and/or persistent mental illness
Key exclusion criteria (9 listed)
- Hospitalized within the preceding 3 months with life-threatening illness or injury.
- Patients may be enrolled into the study if they had a hospitalization within the preceding 3 months that is determined to be non-serious. Non-serious admissions are defined as those admissions that are non-life threatening and/or potentially impacting patient's well-being long-term or likely to precipitate additional future admissions. Examples of non-life-threatening hospitalizations could be, but may not be limited to, admission for a bronchoscopy, admission for deep vein thrombosis, or admission to ED resulting in overnight stay for cardiac work-up.
- Admitted from a location other than home (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility)
- Anticipated or actual discharge to a location other than independent in a home setting (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility, home hospice)
- Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for hemodialysis, disruptive chemotherapy/radiation regimen)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile mindfulness-based trainingThe intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 6 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group. | Behavioural | App introduction to intervention, App response to symptoms, High dose, Standard dose, Therapist introduction to intervention, Therapist response to symptoms |
Primary outcome
Patient Health Questionnaire-9 Item Scale (PHQ-9)
Time frame: 1 month post-randomization
Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse)
23 secondary outcomes
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time frame: Between baseline 1 month post-randomization
Patient Health Questionnaire-9 Item Scale (PHQ-9)
Time frame: Between baseline 3 months post-randomization
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time frame: Between baseline 3 months post-randomization
Post-Traumatic Stress Symptom Inventory (PTSS)
Time frame: Between baseline 3 months post-randomization
Intervention Adherence: Activity in App During Final Week of Intervention
Time frame: 1 month post-randomization
Intervention Adherence: Number of Views of Content
Time frame: 1 month post-randomization
Client Satisfaction Questionnaire (CSQ)
Time frame: 3 months post-randomization
Systems Usability Scale (SUS)
Time frame: 3 months post-randomization
Mindful Attention Awareness Scale (MAAS)
Time frame: Between baseline and 1 month post-randomization
Mindful Attention Awareness Scale (MAAS)
Time frame: Between baseline 3 months post-randomization
Patient Health Questionnaire 10-item Scale (PHQ-10)
Time frame: Between baseline and 1 month post-randomization
Patient Health Questionnaire 10-item Scale (PHQ-10)
Time frame: Between baseline 3 months post-randomization
EuroQOL Scale
Time frame: Between baseline and 1 month post-randomization
Change in EuroQOL Scale
Time frame: Between baseline 3 months post-randomization
Distress Associated With Depression Symptom Frequency
Time frame: Between baseline and 1 month post-randomization; THIS WAS NOT RECORDED
Distress Associated With Depression Symptom Frequency
Time frame: At 1 month post-randomization
Distress Associated With Anxiety Symptom Frequency
Time frame: At 1 month post-randomization
Distress Associated With Anxiety Symptom Frequency
Time frame: Between baseline 3 months post-randomization
Distress Associated With PTSD Symptom Frequency
Time frame: At 1 month post-randomization
Distress Associated With PTSD Symptom Frequency
Time frame: At 3 months post-randomization
Post-Traumatic Stress Symptom Inventory (PTSS)
Time frame: Between baseline and 1 month post-randomization
Client Satisfaction Questionnaire (CSQ)
Time frame: 1 month post-randomization
Systems Usability Scale (SUS)
Time frame: 1 month post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24303911Cox 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.
- Background: PubMed 29793970Cox 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.
- Background: PubMed 32805434Cox CE, Olsen MK, Gallis JA, Porter LS, Greeson JM, Gremore T, Frear A, Ungar A, McKeehan J, McDowell B, McDaniel H, Moss M, Hough CL. Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial. Contemp Clin Trials. 2020 Sep;96:106119. doi: 10.1016/j.cct.2020.106119. Epub 2020 Aug 15.
- Derived from this study: PubMed 42769870Shubert I, Poehlein E, Ashana DC, Kuchibhatla M, Gallis JA, Olsen MK, Porter LS, Moss M, Hough CL, Cox CE. Predictive Utility of In-Hospital Screening for Postdischarge Depression Symptoms Among Survivors of Critical Illness. CHEST Crit Care. 2026 Sep;4(3):100279. doi: 10.1016/j.chstcc.2026.100279. Epub 2026 May 15.
- Derived from this study: PubMed 38805199Cox CE, Gallis JA, Olsen MK, Porter LS, Gremore T, Greeson JM, Morris C, Moss M, Hough CL. Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors: A Randomized Clinical Trial. JAMA Intern Med. 2024 Jul 1;184(7):749-759. doi: 10.1001/jamainternmed.2024.0823.
- Individual participant dataSharing planned: Yes. We will follow NIH/NCCIH guidelines for data access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher E Cox, MD principal investigator
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile mindfulness-based training in people with Cardiorespiratory Failure, run by Duke University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 Item Scale (PHQ-9) (time frame: 1 month post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04038567, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.