Status:
WITHDRAWN
Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics
Lead Sponsor:
VA Office of Research and Development
Conditions:
Sleep Wake Disorders
Sleep Disturbance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study aims are to: 1) optimize the Transdiagnostic Sleep and Circadian Intervention (TranS-C) for delivery to Veterans in cardiac rehabilitation, 2) test and refine the adapted TranS-C treatment m...
Detailed Description
Aim 1 will involve formative work to optimize the TranS-C manual and protocol for delivery in Cardiac Rehabilitation, with input from Veterans and provider stakeholders. Aim 2 will involve a prelimina...
Eligibility Criteria
Inclusion
- Veteran
- Age 18 years or older
- Referred for VAPHS cardiac rehabilitation
- Self-reported sleep disturbance or sleep-related impairment, determined by PROMIS Sleep Disturbance T-score at least 55 (raw score at least 25) or PROMIS Sleep-Related Impairment T-score at least 55 (raw score at least 20)
- English language fluency
- Willing and able to voluntarily participate in a behavioral sleep intervention clinical research study
- Willing to permit study personnel access to VA EHR
- Willing to permit study personnel to communicate with routine VA healthcare providers
- Willing and able to participate in outpatient cardiac rehabilitation at VAPHS
Exclusion
- Moderate to severe cognitive impairment
- Active suicidal ideation, plan, or intent
- Current moderate to severe alcohol or substance use disorder
- Current severe symptoms of depression, anxiety, mania/hypomania, psychosis, or PTSD
- Currently engaged in a non-pharmacological intervention for sleep
- Currently working night shifts
- Currently pregnant and/or breast-feeding
Key Trial Info
Start Date :
January 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04506112
Start Date
January 27 2022
End Date
April 16 2023
Last Update
May 10 2023
Active Locations (1)
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1
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240