Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics

NCT ID: NCT04506112

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-27
• Study Completion Date: 2023-04-16

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TranS-C + Usual Care

Participants in this group will receive TranS-C and will continue with care in cardiac rehabilitation as usual.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

Usual Care

Participants in this group will receive only usual care and thus will continue with care in cardiac rehabilitation as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

TranS-C

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caitlan A. Tighe, PhD MA

Role: PRINCIPAL_INVESTIGATOR

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Locations

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

RX003393

Identifier Type: REGISTRY

Identifier Source: secondary_id

E3393-W

Identifier Type: -

Identifier Source: org_study_id