Optimizing a Mobile Mindfulness Intervention for ICU Survivors

Cardiorespiratory Failure Clinical Trial

— LIFT2  

Official title:

Optimizing a Self-directed Mobile Mindfulness Intervention for Improving Cardiorespiratory Failure Survivors' Psychological Distress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04038567
• Other study ID #: Pro00100252
• Secondary ID: 1U01AT009974
• Status: Completed
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: July 19, 2023

Study information

• Verified date: March 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: July 19, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 or face mask oxygen 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 pulmonary vascular vasoactive medications

• use of aortic balloon pump for cardiogenic shock for =1 hour

3. 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.

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 serious enough to limit completion of study procedures in the opinion of the site investigator.

6. English fluency.

EXCLUSION CRITERIA (in hospital):

1. 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.

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 the following at T1: PHQ-9 score <5

8. Failure to randomize within 2 month (60 days) post-discharge.

Related Conditions & MeSH terms

• Cardiorespiratory Failure

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado - Denver	Aurora	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Washington	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	National Center for Complementary and Integrative Health (NCCIH), University of Colorado, Denver, University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cox 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. — View Citation

Cox 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Health Questionnaire-9 Item scale (PHQ-9)	Depression symptoms. Scores range from 0 (better) to 27 (worse)	Between baseline and 1 month post-randomization
Secondary	Change in Patient Health Questionnaire-9 Item scale (PHQ-9)	Depression symptoms. Scores range from 0 (better) to 27 (worse)	Between baseline 3 months post-randomization
Secondary	Change in Generalized Anxiety Disorder 7-item scale (GAD-7)	Anxiety symptoms. Scores range from 0 (better) to 21 (worse)	Between baseline 3 months post-randomization
Secondary	Change in Post-Traumatic Stress Symptom inventory (PTSS)	PTSD symptoms. Scores can range from 10 (best) to 70 (worst).	Between baseline 3 months post-randomization
Secondary	Intervention adherence	Quantified by number of intervention sessions, weekly surveys, and intervention elements (e.g., videos, audio) completed.	1 month post-randomization
Secondary	Intervention adherence	Quantified by number of intervention sessions, weekly surveys, and intervention elements (e.g., videos, audio) completed.	3 months post-randomization
Secondary	Client Satisfaction Questionnaire (CSQ)	A measure of acceptability. Scores can range from 8 (worst) to 32 (best)	3 months post-randomization
Secondary	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)	3 months post-randomization
Secondary	Change in Mindful Attention Awareness Scale (MAAS)	A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best).	Between baseline and 1 month post-randomization
Secondary	Change in Mindful Attention Awareness Scale (MAAS)	A measure of mindfulness qualities. Scores can range from 5 (worst) to 30 (best).	Between baseline 3 months post-randomization
Secondary	Change in Patient Health Questionnaire 10-item scale (PHQ-10)	An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst).	Between baseline and 1 month post-randomization
Secondary	Change in Patient Health Questionnaire 10-item scale (PHQ-10)	An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 10 (best) to 20 (worst).	Between baseline 3 months post-randomization
Secondary	Change in EuroQOL scale	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)	Between baseline and 1 month post-randomization
Secondary	Change in EuroQOL scale	A measure of quality of life. Scores can range from 0 (worst) to 100 (best)	Between baseline 3 months post-randomization
Secondary	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)	Between baseline and 1 month post-randomization
Secondary	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)	Between baseline 3 months post-randomization
Secondary	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)	Between baseline and 1 month post-randomization
Secondary	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)	Between baseline 3 months post-randomization
Secondary	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)	Between baseline and 1 month post-randomization
Secondary	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)	Between baseline 3 months post-randomization
Secondary	Change in Generalized Anxiety Disorder 7-item scale (GAD-7)	Anxiety symptoms. Scores range from 0 (better) to 21 (worse)	Between baseline and 1 month post-randomization
Secondary	Change in Post-Traumatic Stress Symptom inventory (PTSS)	Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst).	Between baseline and 1 month post-randomization
Secondary	Client Satisfaction Questionnaire (CSQ)	A measure of acceptability. Scores can range from 8 (worst) to 32 (best)	1 month post-randomization
Secondary	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)	1 month post-randomization