NCT04506112

Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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 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.

Conditions

• Sleep Wake Disorders
• Sleep Disturbance
• Sleep-Related Impairment

Interventions

Type	Name	Description
BEHAVIORAL	Transdiagnostic Sleep and Circadian Intervention (TranS-C), adapted for cardiac rehabilitation	Participants will complete the TranS-C intervention as adapted for cardiac rehabilitation. TranS-C is a behavioral intervention that is rooted in basic sleep and circadian science and draws from empirically-supported treatments including Cognitive Behavioral Therapy for Insomnia (CBT-I), Interpersonal and Social Rhythm Therapy (IPSRT), chronotherapy, and light therapy. It was designed to promote sleep health across a range of sleep problems. Participants in this group will also continue to receive care as usual, cardiac/sleep-related or otherwise.

Timeline

• Start date: 2022-01-27
• Primary completion: 2023-04-16
• Completion: 2023-04-16
• First posted: 2020-08-10
• Last updated: 2023-05-10

Locations

1 site across 1 country: United States