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Internet Cognitive Behavioral Therapy for Insomnia to Prevent Cardiovascular Disease

NCT04059302 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-07-19

No results posted yet for this study

Summary

This randomized controlled trial will test the efficacy of online cognitive-behavioral therapy for insomnia (CBT-I) to improve markers of subclinical cardiovascular disease risk among middle aged adults (40-64 years) with chronic insomnia who are at moderate-to-high risk for cardiovascular disease. Multiple trials have revealed face to face and digital CBT-I improves insomnia symptoms and associated daytime functioning. However, CBT-I has not been tested as a primary prevention intervention to reduce risk for CVD. Mid-life adults are a high-risk group for the emergence of CVD with detrimental consequences pervading into older adulthood including reduced quality of life and greater health care costs. The investigators will evaluate whether online CBT-I affects vascular and cardiac function and structure at post-treatment and 8-week follow-up in a community-based sample.

Hypothesis 1: Online CBT-I will improve indices of cardiovascular function and structure compared to a wait-list control group at post-treatment.

Hypothesis 2: Improvements in indices of cardiovascular function and structure will be maintained at 8-week follow-up in the online CBT-I group.

Conditions

  • Insomnia Chronic
  • Subclinical Disease and/or Syndrome

Interventions

BEHAVIORAL

Internet-delivered Cognitive Behavioral Therapy for Insomnia

The therapy consists of 6 modules or 'cores' that are introduced on a weekly basis. The cores are designed to decrease sleep-inhibiting cognitions and behaviors, and to alter sleep-wake schedules.

Sponsors & Collaborators

  • Megan Petrov

    lead OTHER

Principal Investigators

  • Megan E Petrov, PhD · Arizona State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-20
Primary Completion
2021-07-15
Completion
2021-07-15

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 NCT04059302 on ClinicalTrials.gov