Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics

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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Withdrawn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

Trial design

0 participants in 2 patient groups

TranS-C + Usual Care
Experimental group
Description:
Participants in this group will receive TranS-C and will continue with care in cardiac rehabilitation as usual.
Treatment:
Behavioral: Transdiagnostic Sleep and Circadian Intervention (TranS-C), adapted for cardiac rehabilitation
Usual Care
No Intervention group
Description:
Participants in this group will receive only usual care and thus will continue with care in cardiac rehabilitation as usual.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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