Clinical trial NCT06538246: Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors
Official title: Self-directed Mobile Adaptive Coping Skills Intervention to Improve Psychological Distress Symptoms Among Cardiorespiratory Failure Survivors: Blueprint 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Post-traumatic Stress Disorder
Stress
Worries; Pain or Disability
Breath Shortness
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: University of Colorado, Denver
name: University of California, Los Angeles
First posted: 2024-08-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Conditions treated in intensive care units (ICUs) such as the acute respiratory distress syndrome (ARDS), congestive heart failure, COVID pneumonia, and sepsis are common. These can lead to high rates of depression, anxiety, and PTSD that worsen quality of life. Yet there are few effective strategies able to overcome barriers of limited access to mental health care. Even less is known about the experiences of patients from racially and ethnically minoritized populations because of they haven't been included well in past research.

To address this problem, the investigators developed Blueprint, a mobile app that coaches people to use adaptive coping skills to self-manage their symptoms. The investigators found that it reduced depression symptoms and improved quality of life compared to placebo.

To confirm these promising findings, the investigators are doing a formal test of Blueprint. The investigators will enroll 400 people who received ICU care from 4 hospitals (Duke, UCLA, Colorado, and Oregon). These patients will be randomized to receive either the Blueprint mobile app or a special Education Program mobile app the investigators developed. -both delivered through similar mobile app platforms. Our specific aims are to see which program improves symptoms better across 6 months of follow up.

This project addresses national research priorities and could advance the field with a personalizable yet population-focused therapy that could be scaled broadly and efficiently to enhance mental health equity.

Detailed description: Cardiorespiratory conditions such as the acute respiratory distress syndrome (ARDS), congestive heart failure, COVID pneumonia, and sepsis are among the most common causes of mortality and morbidity. They are also notable for high rates of persistent psychological distress symptoms including depression, anxiety, and PTSD that worsen quality of life and outcomes of the underlying conditions. Yet there are few effective strategies able to overcome barriers of limited access to mental health care. Even less is known about distress management among people from structurally disadvantaged backgrounds such as racially and ethnically minoritized populations because of their suboptimal representation in relevant clinical trials.

To fill this gap, the investigators developed Blueprint, an adaptive coping skills training intervention, and have optimized it over years of research. The investigators conducted a multicenter RCT (PCORI PFA 195) of a telephone- and web-based version among those recently hospitalized with serious cardiorespiratory conditions, finding that it reduced depression symptoms and improved quality of life among those with elevated baseline distress. Informed by lessons learned about intervention delivery and eligibility criteria, the investigators next conducted a single-center pilot RCT (R34 HL145387) that targeted a broader population and tested a completely automated, self-guided, symptom-responsive mobile app version of Blueprint. The investigators found excellent adherence and a strong effect on depression, anxiety, PTSD, and quality of life compared to control.

Given these promising findings, a formal test of the Blueprint adaptive coping skills training intervention's efficacy is needed. Therefore, the investigators propose a 5-year multicenter RCT with 6-month follow up in which 400 cardiorespiratory failure survivors with elevated symptoms of psychological distress post-discharge are randomized to either Blueprint or an Education Program control-both delivered through similar mobile app platforms. Our specific aims will: (1) Test Blueprint vs. control on symptoms of depression, anxiety, PTSD, and quality of life; (2) Determine patient-level characteristics associated with a great treatment response among sociodemographic subgroups of interest, also applying a heterogeneity of treatment effects analysis to identify other groups of clinical relevance; and (3) Ensure off-the-shelf intervention readiness for implementation by using an exploratory mixed-methods hybrid type 1 implementation framework analysis that integrates semi-structured interviews with trial participants and quantitative trial data from Aims 1 and 2.

Innovative elements include a fully automated mobile health delivery system that personalizes content in response to changes in symptom trajectories, a focus on racially and ethnically minoritized persons, the integration of a Spanish language intervention version, and strong community engagement. This project addresses national research priorities and could advance the field with a personalizable yet population-focused therapy that could be scaled broadly and efficiently to enhance mental health equity.

Eligibility criteria: Inclusion Criteria Inclusion criteria present in the hospital

1. Adult (age ≥18)
2. Managed in an ICU or stepdown unit for ≥24 hours during the time inclusion criterion #3 is met
3. Serious acute cardiorespiratory condition, defined as ≥1 of the following:

   * mechanical ventilation via endotracheal tube for ≥4 hours
   * non-invasive ventilation (CPAP, BiPAP) for ≥4 hours in a 24-hour period provided for acute respiratory failure
   * new use of supplemental oxygen ≥6 liters per minute (or increase in baseline continuous oxygen)
   * use of vasopressors for shock of any etiology
   * use of inotropes for shock of any etiology
   * use of pulmonary vasodilators
   * use of aortic balloon pump or cardiac assist device for cardiogenic shock
   * use of diuretic intravenous drip
   * evidence of acute coronary ischemia (i.e., elevated troponin level, supporting EKG changes, unstable angina symptoms documented)
   * urgent cardiac catheterization
4. Cognitive status intact

   • No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart
5. Absence of severe mental illness

   * Treatment for severe 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
   * Evidence of poorly managed severe mental illness
   * No endorsement of suicidality at time of admission or informed consent
6. Functional fluency in English or Spanish (i.e., sufficient knowledge of English or Spanish to complete study tasks like watch videos, complete surveys)

Inclusion criteria present after hospital discharge (i.e., at the time of arrival home after discharge from the hospital)

1. Elevated baseline psychological distress symptoms, defined as a Hospital Anxiety and Distress Scale (HADS) total score ≥8

Exclusion Criteria Exclusion criteria present in the hospital

1. Active alcohol or drug abuse (e.g., admission for alcohol withdrawal, drug-related complication, positive toxicology screening at admission, endorsement of active addiction)
2. Anticipated complex medical needs after discharge that would be disruptive to intervention and follow up; for example:

   * Anticipated surgical procedures
   * Anticipated complex medical regiment (e.g., new chemotherapy, new dialysis, need for repeat surgery, pregnant and near term)
   * Plan for comfort care
3. Other complex needs anticipated that could interfere with the ability to complete study procedures. Examples include:

   * Anticipated disruptive travel
   * Inability to use mobile app
   * Anticipated unstable living situation
4. 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)
5. Persistently impaired cognition as a result of illness (Impairment defined as ≥3 errors on the Callahan cognitive status screen and/or the lack of decisional capacity (i.e., patient could be consented by medical team for a procedure if necessary)
6. Currently imprisoned or incarcerated or in home detention
7. Lack a reliable smartphone with cellular data plan or access to the internet
8. Currently enrolled in another study involving an intervention whose objectives conflict with the objectives of this study
9. Previously enrolled in the trial

Exclusion criteria present after hospital discharge (i.e., at T1 Data Collection conducted at the time of arrival home from the hospital)

1. Failure to randomize within 14 days from planned start date (planned start date is within 3 days post-discharge from the hospital to home to accommodate weekends)
2. Readmission to hospital before randomization completed

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 1 month, 3 months, and 6 months post-randomization
Secondary outcomes:
measure: Post-Traumatic Stress Syndrome inventory (PTSS)
timeFrame: Baseline, 1 month, 3 months, and 6 months post-randomization
measure: EuroQOL-5D visual analog scale (EQ VAS) quality of life measure
timeFrame: Baseline, 1 month, 3 months, and 6 months post-randomization
measure: Perceived Stress Scale 4-Item survey (PSS-4)
timeFrame: Baseline, 1 month, 3 months, and 6 months post-randomization
Other outcomes:
measure: Patient Health Questionnaire 10-Item symptoms scale (PHQ-10)
timeFrame: Baseline, 1 month, 3 months, and 6 months post-randomization
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Professor of Medicine
name: Christopher Cox
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.