Mobile Mindfulness Intervention for Psychological Distress Among Intensive Care Unit Survivors: A Randomized Clinical Trial.
Christopher E Cox, John A Gallis, Maren K Olsen...
https://pubmed.ncbi.nlm.nih.gov/38805199Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06538246
Self-directed Mobile Adaptive Coping Skills Intervention to Improve Psychological Distress Symptoms Among Cardiorespiratory Failure Survivors: Blueprint 2
Led by Duke University · Updated on 2026-03-06
400
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
O
Oregon Health and Science University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a mobile app called Blueprint that provides adaptive coping skills training to help survivors of serious cardiorespiratory conditions who have experienced psychological distress such as depression, anxiety, and PTSD. These conditions often occur after critical care in intensive care units for illnesses like ARDS, congestive heart failure, COVID pneumonia, and sepsis. The study aims to compare Blueprint's effects with an education program using mobile app platforms, focusing especially on racially and ethnically minoritized populations that are underrepresented in past research. Participants will be randomly assigned to one of two groups: one receiving the Blueprint mobile app intervention that delivers 4 weeks of coping skills training with weekly safety monitoring surveys, and the other receiving a mobile app-based education program providing condition-specific informational videos also over 4 weeks. Both groups receive complementary printed or PDF workbooks. The interventions are fully automated and self-guided, designed to adapt to symptom changes and are available in English and Spanish. During the 6-month follow-up period, participants will complete assessments including the Hospital Anxiety and Depression Scale (HADS), Post-Traumatic Stress Syndrome inventory, quality of life measures, and stress surveys at baseline, 1 month, 3 months, and 6 months after starting the intervention. Safety is monitored through weekly surveys within the app. The study involves 400 adults who received ICU or stepdown care for serious cardiorespiratory illnesses and have elevated psychological distress after hospital discharge. The trial will provide insights into which app better improves mental health symptoms and quality of life.
CONDITIONS
Brief Title
Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult aged 18 years or older
- Managed in an ICU or stepdown unit for at least 24 hours
- Experienced serious acute cardiorespiratory condition such as mechanical ventilation, non-invasive ventilation, supplemental oxygen, vasopressors, inotropes, pulmonary vasodilators, cardiac assist devices, intravenous diuretics, acute coronary ischemia, or urgent cardiac catheterization
- Cognitive status intact with no significant pre-existing impairment
- No severe mental illness or recent psychiatric hospitalization
- Functional fluency in English or Spanish
- Elevated baseline psychological distress symptoms with a Hospital Anxiety and Depression Scale (HADS) total score of 8 or higher after hospital discharge
You will not qualify if you...
- Active alcohol or drug abuse
- Anticipated complex medical needs after discharge that interfere with intervention or follow-up (e.g., surgery, chemotherapy, dialysis, pregnancy near term, comfort care)
- Other complex needs interfering with study procedures (e.g., disruptive travel, inability to use mobile app, unstable living situation)
- Discharge to non-independent living settings such as nursing home or hospice
- Persistently impaired cognition after illness
- Currently imprisoned or in home detention
- Lack of reliable smartphone with cellular data or internet access
- Enrollment in conflicting intervention studies
- Previous enrollment in this trial
- Failure to randomize within 14 days post-discharge
- Hospital readmission before randomization is completed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) to assess eligibility and baseline psychological distress symptoms post-discharge
Treatment
Duration - 4 weeks
Participants receive either the Blueprint adaptive coping skills intervention or an Education program through a self-guided mobile app over 4 weeks. Weekly sessions include short surveys for safety monitoring and app content is supplemented by a workbook with videos.
Weekly app sessions with self-directed activities and assessments
Follow-up
Duration - 6 months
Participants are monitored for psychological distress symptoms and quality of life up to 6 months after completing the intervention through scheduled assessments.
Assessments at 1 month, 3 months, and 6 months post-randomization via app surveys
Trial Site Locations
Total: 1 location
1
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Loading map...
Research Team
C
Christopher Cox
K
Kristy Johnson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
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.
Christopher E Cox, Catherine L Hough, Derek M Jones...
https://pubmed.ncbi.nlm.nih.gov/29793970