Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics

VA Office of Research and Development

Status

Withdrawn

Conditions

Sleep-Related Impairment

Sleep Disturbance

Sleep Wake Disorders

Treatments

Behavioral: Transdiagnostic Sleep and Circadian Intervention (TranS-C), adapted for cardiac rehabilitation

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT04506112

E3393-W

RX003393 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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