Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics

Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics

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 manual and protocol, and 3) conduct a pilot randomized trial to establish the feasibility, acceptability, and plausibility of the intervention protocol and study procedures.

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 preliminary test and refinement of the adapted TranS-C manual and protocol with a small sample of Veterans who are participating in cardiac rehabilitation and report sleep disturbance and/or sleep-related impairment. Aim 3 will involve a pilot randomized trial to establish the feasibility, acceptability, and plausibility of the intervention protocol and study procedures. Veterans in cardiac rehabilitation with sleep disturbance and/or sleep-related impairment will be randomized to TranS-C + Usual Care or Usual Care. Treatment satisfaction will be assessed at 3-months; sleep disturbance and sleep-related impairment, disability and functioning, and health-related quality of life will be assessed at baseline, 3-months, and 6-months to determine measure responsiveness and provide preliminary insight into treatment effects.

Of note, information provided in this entry (e.g., design, eligibility criteria, outcomes, etc.) pertains only to Aim 3 which includes the pilot randomized trial. Consistent with Stage I of the NIH stage model of behavioral intervention development research, results from Aim 1 and 2 activities may lead to modifications to the pilot protocol and procedures in Aim 3.

Inclusion Criteria:

• 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 Criteria:

• 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