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Optimizing a Mobile Mindfulness Intervention for ICU Survivors (LIFT2)

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ClinicalTrials.gov Identifier: NCT04038567
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : December 5, 2019
Sponsor:
Collaborators:
University of Washington
University of Colorado, Denver
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Duke University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Cardiorespiratory Failure Behavioral: Mobile mindfulness-based training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Factorial experimental trial as part of a multi-phase optimization strategy (MOST) design
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: PIs and analysts blinded to allocation. Outcomes completed by participants using web-based interface and thus outcomes assessors as such are blinded.
Primary Purpose: Supportive Care
Official Title: Optimizing a Self-directed Mobile Mindfulness Intervention for Improving Cardiorespiratory Failure Survivors' Psychological Distress
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: High dose / therapist attention / introductory call
Will receive high dose intervention content, therapist attention to elevated symptoms, and an introductory call from a therapist.
Behavioral: Mobile mindfulness-based training
The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.

Experimental: High dose / therapist attention / no introductory call
Will receive high dose intervention content, therapist attention to elevated symptoms, and no introductory call from a therapist.
Behavioral: Mobile mindfulness-based training
The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.

Experimental: High dose / app attention / introductory call
Will receive high dose intervention content, app-based attention to elevated symptoms, and an introductory call from a therapist.
Behavioral: Mobile mindfulness-based training
The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.

Experimental: High dose / app attention / no introductory call
Will receive high dose intervention content, app-based attention to elevated symptoms, and no introductory call from a therapist.
Behavioral: Mobile mindfulness-based training
The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.

Experimental: Standard dose / therapist attention / introductory call
Will receive standard dose intervention content, therapist-based attention to elevated symptoms, and an introductory call from a therapist.
Behavioral: Mobile mindfulness-based training
The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.

Experimental: Standard dose / therapist attention / no introductory call
Will receive standard dose intervention content, therapist-based attention to elevated symptoms, and no introductory call from a therapist.
Behavioral: Mobile mindfulness-based training
The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.

Experimental: Standard dose / app attention / introductory call
Will receive standard dose intervention content, app-based attention to elevated symptoms, and an introductory call from a therapist.
Behavioral: Mobile mindfulness-based training
The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.

Experimental: Standard dose / app attention / no introductory call
Will receive standard dose intervention content, app-based attention to elevated symptoms, and no introductory call from a therapist.
Behavioral: Mobile mindfulness-based training
The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.




Primary Outcome Measures :
  1. Change in Patient Health Questionnaire-9 Item scale (PHQ-9) [ Time Frame: Between baseline and 1 month post-randomization ]
    Depression symptoms. Scores range from 0 (better) to 27 (worse)

  2. Change in Generalized Anxiety Disorder 7-item scale (GAD-7) [ Time Frame: Between baseline and 1 month post-randomization ]
    Anxiety symptoms. Scores range from 0 (better) to 21 (worse)

  3. Change in Post-Traumatic Stress Symptom inventory (PTSS) [ Time Frame: Between baseline and 1 month post-randomization ]
    Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst).

  4. Client Satisfaction Questionnaire (CSQ) [ Time Frame: 1 month post-randomization ]
    A measure of acceptability. Scores can range from 8 (worst) to 32 (best)

  5. Systems Usability Scale (SUS) [ Time Frame: 1 month post-randomization ]

    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)



Secondary Outcome Measures :
  1. Change in Patient Health Questionnaire-9 Item scale (PHQ-9) [ Time Frame: Between baseline 3 months post-randomization ]
    Depression symptoms. Scores range from 0 (better) to 27 (worse)

  2. Change in Generalized Anxiety Disorder 7-item scale (GAD-7) [ Time Frame: Between baseline 3 months post-randomization ]
    Anxiety symptoms. Scores range from 0 (better) to 21 (worse)

  3. Change in Post-Traumatic Stress Symptom inventory (PTSS) [ Time Frame: Between baseline 3 months post-randomization ]
    PTSD symptoms. Scores can range from 10 (best) to 70 (worst).

  4. Intervention adherence [ Time Frame: 1 month post-randomization ]
    Quantified by number of intervention sessions, weekly surveys, and intervention elements (e.g., videos, audio) completed.

  5. Intervention adherence [ Time Frame: 3 months post-randomization ]
    Quantified by number of intervention sessions, weekly surveys, and intervention elements (e.g., videos, audio) completed.

  6. Client Satisfaction Questionnaire (CSQ) [ Time Frame: 3 months post-randomization ]
    A measure of acceptability. Scores can range from 8 (worst) to 32 (best)

  7. Systems Usability Scale (SUS) [ Time Frame: 3 months post-randomization ]

    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)


  8. Change in Mindful Attention Awareness Scale (MAAS) [ Time Frame: Between baseline and 1 month post-randomization ]
    A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best).

  9. Change in Mindful Attention Awareness Scale (MAAS) [ Time Frame: Between baseline 3 months post-randomization ]
    A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best).

  10. Change in Patient Health Questionnaire 10-item scale (PHQ-10) [ Time Frame: Between baseline and 1 month post-randomization ]
    An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst).

  11. Change in Patient Health Questionnaire 10-item scale (PHQ-10) [ Time Frame: Between baseline 3 months post-randomization ]
    An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst).

  12. Change in EuroQOL scale [ Time Frame: Between baseline and 1 month post-randomization ]
    A measure of quality of life. An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 0 (worst) to 100 (best)

  13. Change in EuroQOL scale [ Time Frame: Between baseline 3 months post-randomization ]
    A measure of quality of life. Scores can range from 0 (worst) to 100 (best)

  14. Distress associated with depression symptom frequency [ Time Frame: Between baseline and 1 month post-randomization ]
    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)

  15. Distress associated with depression symptom frequency [ Time Frame: Between baseline 3 months post-randomization ]
    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)

  16. Distress associated with anxiety symptom frequency [ Time Frame: Between baseline and 1 month post-randomization ]
    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)

  17. Distress associated with anxiety symptom frequency [ Time Frame: Between baseline 3 months post-randomization ]
    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)

  18. Distress associated with PTSD symptom frequency [ Time Frame: Between baseline and 1 month post-randomization ]
    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)

  19. Distress associated with PTSD symptom frequency [ Time Frame: Between baseline 3 months post-randomization ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  1. Adult (age ≥18)
  2. 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 (≥15L/min) or face mask with FiO2 ≥ 0.5 for ≥4 hours in a 24-hour period and / or
    • 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 aortic balloon pump for cardiogenic shock for ≥1 hour

      • In an ICU setting, NOT including the operating room or emergency department.
  3. ICU setting: managed in an adult medical cardiac, trauma, surgical, or neurological ICU for ≥24 hours during the time inclusion criterion #2 is met.
  4. 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
  5. 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 (with the exception of recreational use of cannabis)
  6. Need for a translator because of poor English fluency

EXCLUSION CRITERIA (in hospital):

  1. Hospital inpatient within the 3 months preceding the current admission *
  2. Admitted from a location other than home (e.g., nursing home, long-term acute care facility, inpatient rehabilitation facility)
  3. 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)
  4. Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for hemodialysis, disruptive chemotherapy/radiation regimen)
  5. Unable to complete study procedures as determined by staff
  6. Lack of reliable smartphone with cellular data plan or wifi access

    EXCLUSION CRITERIA (at T1, post-discharge):

  7. Low baseline psychological distress symptoms, defined as the absence of all of the following at T1:

    1. PHQ-9 score <10
    2. GAD-7 <7 [clerical error in early version stated 10]
    3. PTSS <20
  8. Failure to randomize within 1 month post-discharge.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038567


Contacts
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Contact: Christopher Cox, MD 9196817232 christopher.cox@duke.edu
Contact: Allie Frear 9196848914 allie.frear@duke.edu

Locations
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United States, Colorado
University of Colorado - Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Jeffrey McKeehan    303-724-6080    jeffrey.mckeehan@cuanschutz.edu   
Principal Investigator: Marc Moss, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Allie Frear    919-684-8914    allie.frear@duke.edu   
Principal Investigator: Christopher Cox, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Anna Ungar    206-744-7732    amu@uw.edu   
Principal Investigator: Terri Hough, MD         
Sponsors and Collaborators
Duke University
University of Washington
University of Colorado, Denver
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Christopher E Cox, MD Duke University

Publications:
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04038567     History of Changes
Other Study ID Numbers: Pro00100252
1U01AT009974 ( U.S. NIH Grant/Contract )
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will follow NIH/NCCIH guidelines for data access.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: We will follow NIH and institutional guidelines.
Access Criteria: We will follow NIH and institutional guidelines. Given the length of time that will elapse during the study, we will need to adhere to the rules present at that time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
cardiorespiratory failure
critical illness
psychological distress
depression
anxiety
post-traumatic stress disorder
intensive care units
adults
mechanical ventilation