Improving Sleep for Healthy Hearts

Mass General Brigham

Status: Completed

Conditions: Coronary Heart Disease; Insomnia

Treatments: Behavioral: General Sleep Education; Behavioral: Go! to Sleep

Study type: Interventional

Funder types: Other

Identifiers

NCT02848859

2014P000845

Details and patient eligibility

About

This is a pilot study randomizing patients with insomnia and coronary heart disease to either general sleep hygiene counseling and web-based cognitive behavioral therapy for insomnia versus general sleep hygiene counseling alone (followed by the cognitive behavioral therapy at a later date).

Full description

For this pilot study, the investigators will recruit up to 30 participants with insomnia and coronary heart disease. Another 30 patients will be recruited from another institution. Patients will be screened with a modified version of the Insomnia Severity Index (ISI), a brief self-report instrument validated for identifying insomnia. The investigators will modify the ISI to include exclusionary criteria. The investigators will randomize participants to 6 weeks of access to web based cognitive behavioral therapy for insomnia (wCBT-I) using an internet based CBT-I program plus education provided through access to the Harvard Sleep Education web site (which provides general sleep education information only) compared to 6 weeks of access to the Harvard Sleep Education web site, followed by access to the web-CBT program (a wait list control group). The investigators will test the hypothesis that use of wCBT-I improves sleep quality and sleep duration as measured by sleep diaries and the ISI. A secondary goal of the study is to assess the recruitment yields, retention and adherence rates.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• meet criteria for at least mild insomnia based on the Insomnia Severity Index questionnaire results
• have established coronary disease defined by: a) prior myocardial infarction or a coronary artery revascularization procedure; b) angiographically documented stenosis (>70%) of a major coronary artery; or c) prior ischemic stroke without major functional impairment.
• minimum age of 18 years old.

Exclusion criteria

• no daily access to a computer with an internet connection
• visual impairment preventing use of a computer
• inability to read English
• severe uncontrolled medical or psychiatric problems
• heart failure with reduced ejection fraction <35%
• high depressive symptoms (PHQ > 15)
• drowsy driving
• >3 days per week use of hypnotic medications
• known untreated sleep disordered breathing, narcolepsy, or restless leg syndrome
• shift-workers
• prior exposure to CBT-I treatment
• dialysis patient

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups, including a placebo group

Intervention: Go! to Sleep

Active Comparator group

Description:

We are using a web-based cognitive behavioral therapy program called Go! to Sleep. Go! to Sleep is an interactive online program developed by specialists in Cleveland Clinic's Wellness Institute and Sleep Disorders Center. The program is a 6 week self-help program that uses cognitive behavioral therapy techniques that have been proven to be effective in decreasing symptoms of insomnia.

Treatment:

Behavioral: Go! to Sleep

Behavioral: General Sleep Education

General Sleep Hygiene Education

Placebo Comparator group

Description:

General Sleep Hygiene Education is the first step in the treatment of any sleep disorder. Both arms will have access to a Harvard sleep education web site that provides general information about sleep as well as sleep hygiene.

Treatment:

Behavioral: General Sleep Education