Internet Cognitive Behavioral Therapy for Insomnia to Prevent Cardiovascular Disease

Stopped early · Not applicable

Conditions studied: Insomnia Chronic, Subclinical Disease and/or Syndrome

In brief

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.

Key facts

Study ID

NCT04059302

Run by

Megan Petrov

People needed

12

Starts

2019-09-20

Expected to finish

2021-07-15

Last updated by the study team

2023-07-19

Who can join

Age: 40 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All participants must be 40-64 years of age, able to understand English, score 10 or higher on the Insomnia Severity Index, >30 minutes nocturnal wakefulness (sleep onset latency or wake after sleep onset) for at least 3 nights per week, meet International Classification of Sleep Disorders-III [ISCD-3] diagnostic criteria for an insomnia disorder (see below), have a family history of cardiovascular disease, and screen positive for impaired FMD (< 7% difference between brachial artery diameter before and after occlusion).
• ICSD-3 criteria for insomnia disorder:
• A. The patient reports one or more of the following:
• Difficulty initiating sleep.
• Difficulty maintaining sleep.
• Waking up earlier than desired.
• B. The patient reports, one or more of the following related to the nighttime sleep difficulty:
• Fatigue/malaise.
• Attention, concentration, or memory impairment.
• Impaired social, family, occupational, or academic performance.
• Mood disturbance/irritability.
• Daytime sleepiness.
• Behavioral problems (e.g., hyperactivity, impulsivity, aggression).
• Reduced motivation/energy/initiative.
• Proneness for errors/accidents.
• Concerns about or dissatisfaction with sleep. C. The reported sleep/wake complaints cannot be explained purely by inadequate opportunity (i.e., enough time is allotted for sleep) or inadequate circumstances (i.e., the environment is safe, dark, quiet, and comfortable) for sleep.
• D. The sleep disturbance and associated daytime symptoms occur at least three times per week.
• E. The sleep disturbance and associated daytime symptoms have been present for at least three months F. The sleep/wake difficulty is not better explained by another sleep disorder.

You may not qualify if…

• Participant will be excluded if they screen positive using retrospective questionnaires for other sleep disorders (see appendix of questionnaires), are involved in shift work, have a personal history of cardiovascular disease (i.e., myocardial infarction, atrial fibrillation, stroke, transient ischemic attack, diabetes, peripheral vascular disease), untreated Stage 2 hypertension (i.e., systolic blood pressure ≥ 160; diastolic blood pressure ≥ 100), current or diagnosis of psychiatric disorder within the past six months (including psychotic, mood, and anxiety disorders), start of psychotherapy within the past 6 months, clinically significant depressive symptoms as measured by a score of 10 or greater on the Center for Epidemiologic Studies Depression (CESD)-10 Revised scale, current or previous history of behavioral interventions for insomnia, currently smoking or using other nicotine products, excessive use of caffeine (>4 cups/day) or alcohol (>2 drinks/day), current and frequent use (2+ per week) of sleep medications, and engaging in vigorous exercise 75+ minutes/week. Women who are peri-menopausal, pregnant, breastfeeding, or trying to become pregnant will also be excluded.

Where it is running

• Arizona State University — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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