Status:
TERMINATED
Internet Cognitive Behavioral Therapy for Insomnia to Prevent Cardiovascular Disease
Lead Sponsor:
Megan Petrov
Conditions:
Insomnia Chronic
Subclinical Disease and/or Syndrome
Eligibility:
All Genders
40-64 years
Phase:
NA
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 adul...
Detailed Description
In this randomized controlled trial, comparing internet-delivered cognitive behavioral therapy for insomnia (CBT-I) to a wait-list control group on pre-post trial changes in indices of cardiovascular ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04059302
Start Date
September 20 2019
End Date
July 15 2021
Last Update
July 19 2023
Active Locations (1)
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1
Arizona State University
Phoenix, Arizona, United States, 85004