Internet Cognitive Behavioral Therapy for Insomnia to Prevent Cardiovascular Disease

NCT04059302 | Terminated

• 1 other identifier: STUDY00004470
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Baseline to Post-Treatment endothelial-dependent dilation of the brachial artery (FMD)

  A non-invasive assessment of the ability of the brachial (upper arm) artery to dilate in response to an increase in blood flow, and is assessed using ultrasound.

  Baseline; Post-treatment: 7 weeks after treatment initiation

Secondary Outcomes (5)

• Change in baseline to post-treatment carotid-femoral pulse wave velocity (a measure of aortic stiffness)

  Baseline; Post-treatment: 7 weeks after treatment initiation

• Change in Baseline to Post-Treatment Indices of Cardiac Structure via Resting Echocardiography Imaging

  Baseline; Post-treatment: 7 weeks after treatment initiation

• Change in Baseline to Post-Treatment Central Augmentation Index

  Baseline; Post-treatment: 7 weeks after treatment initiation

• Change in Baseline to Post-Treatment Central Systolic blood pressure

  Baseline; Post-treatment: 7 weeks after treatment initiation

• Change in Baseline to Post-Treatment Central Pulse Pressure

  Baseline; Post-treatment: one week after treatment completion; Follow-up for experimental group only: 8 weeks after post-treatment visit

Study Arms (2)

Online CBT-I

EXPERIMENTAL

Fully-automated, internet-delivered cognitive behavioral therapy for insomnia program that consists of 6 therapy cores delivered weekly over 6 weeks.

Behavioral: Internet-delivered Cognitive Behavioral Therapy for Insomnia

Wait-List Control

NO INTERVENTION

Wait-list control group will receive no intervention until after the trial period is completed. During the trial period they will complete all study assessments, but receive no active treatment.

Interventions

Internet-delivered Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

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.

Online CBT-I

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

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.

Sponsors & Collaborators

• Megan Petrov: lead

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Megan E Petrov, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The ultra sound technician that will be evaluating the primary outcome measures will be blinded to participant condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: August 16, 2019
• Study Start: September 20, 2019
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

US (1)