Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors
NCT Number: NCT06538246
Acronym: Blueprint 2
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression|Anxiety|Post-traumatic Stress Disorder|Stress|Worries; Pain or Disability|Breath Shortness
Interventions: BEHAVIORAL: Blueprint|BEHAVIORAL: Education program
Sponsor: Duke University
Collaborators: Oregon Health and Science University|University of Colorado, Denver|University of California, Los Angeles
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-15
Completion Date: 2028-04-15
Locations: Duke University Medical Center, Durham, North Carolina, 27710, United States

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.

Primary Outcome Measures: Hospital Anxiety and Depression Scale (HADS), The HADS evaluates anxiety (7 items) and depression (7 items) with a 14-item instrument assessing symptoms on a 4-point scale rated from 0 "not at all" to 3 "very often indeed". It has a score range of 0 to 42 with higher scores indicating more symptoms., Baseline, 1 month, 3 months, and 6 months post-randomization
Secondary Outcome Measures: Post-Traumatic Stress Syndrome inventory (PTSS), The PTSS rates 10 post-traumatic stress symptoms and has a score range of 10 (no symptoms) to 70 (high burden of symptoms)., Baseline, 1 month, 3 months, and 6 months post-randomization|EuroQOL-5D visual analog scale (EQ VAS) quality of life measure, The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' (100) and 'Worst imaginable health state' (0). The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement., Baseline, 1 month, 3 months, and 6 months post-randomization|Perceived Stress Scale 4-Item survey (PSS-4), This is a 4-item short version of the PSS. Scores can range from 0 (lowest stress) to 16 (highest level of stress), Baseline, 1 month, 3 months, and 6 months post-randomization
Other Outcome Measures: Patient Health Questionnaire 10-Item symptoms scale (PHQ-10), The PHQ-10 is an adapted version of the PHQ-15, a measure of physical symptoms. Scores can range from 0 (best) to 30 (worst)., Baseline, 1 month, 3 months, and 6 months post-randomization