Adaptive Coping Skills Training to Improve Psychological Distress Among Cardiorespiratory Failure Survivors

Not Applicable

Not yet recruiting

• Conditions: Depression; Anxiety; Post-traumatic Stress Disorder; Stress; Worries; Pain or Disability; Breath Shortness

• Registration Number: NCT06538246
• Lead Sponsor: Duke University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-26
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Inclusion Criteria Inclusion criteria present in the hospital<br><br> 1. Adult (age =18)<br><br> 2. Managed in an ICU or stepdown unit for =24 hours during the time inclusion criterion<br> #3 is met<br><br> 3. Serious acute cardiorespiratory condition, defined as =1 of the following:<br><br> - mechanical ventilation via endotracheal tube for =4 hours<br><br> - non-invasive ventilation (CPAP, BiPAP) for =4 hours in a 24-hour period<br> provided for acute respiratory failure<br><br> - new use of supplemental oxygen =6 liters per minute (or increase in baseline<br> continuous oxygen)<br><br> - use of vasopressors for shock of any etiology<br><br> - use of inotropes for shock of any etiology<br><br> - use of pulmonary vasodilators<br><br> - use of aortic balloon pump or cardiac assist device for cardiogenic shock<br><br> - use of diuretic intravenous drip<br><br> - evidence of acute coronary ischemia (i.e., elevated troponin level, supporting<br> EKG changes, unstable angina symptoms documented)<br><br> - urgent cardiac catheterization<br><br> 4. Cognitive status intact<br><br> - No history of pre-existing significant cognitive impairment (e.g., dementia) as<br> per medical chart<br><br> - Absence of current significant cognitive impairment (impairment defined as =3<br> errors on the Callahan cognitive status screen)<br><br> - Decisional capacity present (i.e., patient could be consented by medical team<br> for a procedure if necessary)<br><br> 5. Absence of severe mental illness<br><br> - Treatment for severe mental illness (e.g., psychosis, bipolar affective<br> disorder, schizoaffective disorder, schizoid personality disorder,<br> schizophrenia [as per medical record], hospitalization for any psychiatric<br> disorder) within the 6 months preceding the current hospital admission<br><br> - Evidence of poorly managed severe mental illness<br><br> - No endorsement of suicidality at time of admission or informed consent<br><br> 6. Functional fluency in English or Spanish (i.e., sufficient knowledge of English or<br> Spanish to complete study tasks like watch videos, complete surveys)<br><br>Inclusion criteria present after hospital discharge (i.e., at the time of arrival home<br>after discharge from the hospital)<br><br> 1. Elevated baseline psychological distress symptoms, defined as a Hospital Anxiety and<br> Distress Scale (HADS) total score =8<br><br>Exclusion Criteria Exclusion criteria present in the hospital<br><br> 1. Active alcohol or drug abuse (e.g., admission for alcohol withdrawal, drug-related<br> complication, positive toxicology screening at admission, endorsement of active<br> addiction)<br><br> 2. Anticipated complex medical needs after discharge that would be disruptive to<br> intervention and follow up; for example:<br><br> - Anticipated surgical procedures<br><br> - Anticipated complex medical regiment (e.g., new chemotherapy, new dialysis,<br> need for repeat surgery, pregnant and near term)<br><br> - Plan for comfort care<br><br> 3. Other complex needs anticipated that could interfere with the ability to complete<br> study procedures. Examples include:<br><br> - Anticipated disruptive travel<br><br> - Inability to use mobile app<br><br> - Anticipated unstable living situation<br><br> 4. Anticipated or actual discharge to a location other than independent in a home<br> setting (e.g., nursing home, long-term acute care facility, inpatient rehabilitation<br> facility, home hospice)<br><br> 5. Currently imprisoned or incarcerated<br><br> 6. Lack a reliable smartphone with cellular data plan or access to the internet<br><br> 7. Previously enrolled in the trial<br><br>Exclusion criteria present after hospital discharge (i.e., at T1 Data Collection<br>conducted at the time of arrival home from the hospital)<br><br> 1. Failure to randomize within 1 month after discharge from the hospital to home<br><br> 2. Readmission to hospital before randomization completed

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS)

Secondary Outcome Measures

Name	Time	Method
Post-Traumatic Stress Syndrome inventory (PTSS);EuroQOL-5D visual analog scale (EQ VAS) quality of life measure;Perceived Stress Scale 4-Item survey (PSS-4)