Optimizing a Mobile Mindfulness Intervention for ICU Survivors

NCT04038567 | Completed Results DMC

• 2 other identifiers: Pro001002521U01AT009974
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 3

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.

Conditions

Cardiorespiratory Failure

Keywords

cardiorespiratory failure; critical illness; psychological distress; depression; anxiety; post-traumatic stress disorder; intensive care units; adults; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire-9 Item Scale (PHQ-9)

  Absolute values, not change scores. Depression symptoms. Scores range from 0 (better) to 27 (worse)

  1 month post-randomization

Secondary Outcomes (23)

• Generalized Anxiety Disorder 7-item Scale (GAD-7)

  Between baseline 1 month post-randomization

• Patient Health Questionnaire-9 Item Scale (PHQ-9)

  Between baseline 3 months post-randomization

• Generalized Anxiety Disorder 7-item Scale (GAD-7)

  Between baseline 3 months post-randomization

• Post-Traumatic Stress Symptom Inventory (PTSS)

  Between baseline 3 months post-randomization

• Intervention Adherence: Activity in App During Final Week of Intervention

  1 month post-randomization

Study Arms (6)

App introduction to intervention

OTHER

Introduction to intervention via the mobile app itself.

Behavioral: Mobile mindfulness-based training

Therapist introduction to intervention

OTHER

Introduction to intervention via a call from the study therapist.

Behavioral: Mobile mindfulness-based training

Standard dose

OTHER

Standard dose of meditation time (once a day).

Behavioral: Mobile mindfulness-based training

High dose

OTHER

High dose of meditation time (twice a day).

Behavioral: Mobile mindfulness-based training

App response to symptoms

OTHER

Mobile app response to elevated psychological distress symptoms during intervention period.

Behavioral: Mobile mindfulness-based training

Therapist response to symptoms

OTHER

Therapist call in response to elevated psychological distress symptoms during intervention period.

Behavioral: Mobile mindfulness-based training

Interventions

Mobile mindfulness-based training BEHAVIORAL

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.

App introduction to intervention; App response to symptoms; High dose; Standard dose; Therapist introduction to intervention; Therapist response to symptoms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Duke University: lead
• University of Washington: collaborator
• University of Colorado, Denver: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (3)

University of Colorado - Denver

Aurora, Colorado, 80045, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (4)

• 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.

  PMID: 24303911 BACKGROUND

• 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.

  PMID: 29793970 BACKGROUND

• 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.

  PMID: 32805434 BACKGROUND

• Cox 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.

  PMID: 38805199 DERIVED

MeSH Terms

Conditions

Critical Illness; Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Results Point of Contact

• Title: Christopher Cox
• Organization: Duke University

christopher.cox@duke.edu

919-681-7232

Study Officials

• Christopher E Cox, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: PIs and analysts blinded to allocation. Outcomes completed by participants using web-based interface and thus outcomes assessors as such are blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Factorial experimental trial as part of a multi-phase optimization strategy (MOST) design

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 31, 2019
• Study Start: August 15, 2019
• Primary Completion: May 1, 2023
• Study Completion: July 19, 2023
• Last Updated: August 15, 2024
• Results First Posted: August 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (3)