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

Overview

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.

Interventions

• Behavioral Blueprint
  This is a mobile app-based adaptive coping skills intervention that lasts 1 month
• Behavioral Education program
  This is a mobile app-based education program that lasts 1 month

Primary outcome measures

• Hospital Anxiety and Depression Scale (HADS) [Time frame: Baseline, 1 month, 3 months, and 6 months post-randomization]

Secondary outcome measures (3)

• Post-Traumatic Stress Syndrome inventory (PTSS) [Time frame: Baseline, 1 month, 3 months, and 6 months post-randomization]
• EuroQOL-5D visual analog scale (EQ VAS) quality of life measure [Time frame: Baseline, 1 month, 3 months, and 6 months post-randomization]
• Perceived Stress Scale 4-Item survey (PSS-4) [Time frame: Baseline, 1 month, 3 months, and 6 months post-randomization]

Eligibility criteria

Inclusion Criteria Inclusion criteria present in the hospital

• Adult (age ≥18)
• Managed in an ICU or stepdown unit for ≥24 hours during the time inclusion criterion #3 is met
• 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
• Cognitive status intact

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

• Active alcohol or drug abuse (e.g., admission for alcohol withdrawal, drug-related complication, positive toxicology screening at admission, endorsement of active addiction)
• 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
• 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
• 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)
• 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)
• Currently imprisoned or incarcerated or in home detention
• Lack a reliable smartphone with cellular data plan or access to the internet
• Currently enrolled in another study involving an intervention whose objectives conflict with the objectives of this study
• 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)

• 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)
• Readmission to hospital before randomization completed

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Duke University Medical Center — Durham

Publications

• 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
• 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
• Baudier RL, Mosack KE, Lapidus JA, Porter LS, Anderson A, Hope AA, Johnson A, Johnson K, Lesowski K, Avallone Mantelli R, Marentes Ruiz CJ, McDougal M, Mejia-Flores L, Mitchell J, Moss M, Neville TH, Estela Vasquez Guzman C, Vu A, Wolwowicz EL, Hough CL, Morris CD, Cox CE. Blueprint 2: A self-directed mobile adaptive coping skills intervention to improve psychological distress symptoms among cardi PMID 42217309

Identifiers

NCT: NCT06538246 · Pro00115623

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗