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Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics

NCT04506112 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-05-10

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Caitlan A. Tighe, PhD MA · VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-27
Primary Completion
2023-04-16
Completion
2023-04-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04506112 on ClinicalTrials.gov