Improving Sleep for Healthy Hearts

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Improving Sleep for Healthy Hearts

Conditions
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Insomnia, Coronary Heart Disease

Intervention / Treatment
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* Behavioral: Go! to Sleep
* Behavioral: General Sleep Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention: Go! to Sleep<br>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. | Behavioral: Go! to Sleep<br>* This is an online interactive program that delivers cognitive behavioral therapy for insomnia via the internet.<br>* Other names: web-based cognitive behavioral therapy;Behavioral: General Sleep Education<br>* Providing patients information on healthy sleep and habits to promote healthy sleep.<br>|
| Placebo Comparator: General Sleep Hygiene Education<br>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. | Behavioral: General Sleep Education<br>* Providing patients information on healthy sleep and habits to promote healthy sleep.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Insomnia Severity Index score at 6 weeks | It is a 7 item, validated questionnaire to determine severity of insomnia symptoms. | At baseline, at 6 weeks, and in the treatment arm at 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep duration from baseline to 6 weeks | The investigators will use sleep diaries that participants fill out for 1 week at baseline and at 6 weeks to compare sleep duration between arms as well as at 12 weeks in the treatment arm only to assess duration of treatment effect. | At baseline, at 6 weeks, and in the treatment arm at 12 weeks. | 
| Change in mood assessed using the Patient Health Questionnaire-8 from baseline to 6 weeks | The investigators will use the Patient Health Questionnaire-8 to measure depressive symptoms | At baseline, at 6 weeks, and in the treatment arm at 12 weeks. | 
| Change in sleepiness assessed using the Epworth Sleepiness Questionnaire from baseline to 6 weeks | The investigators will use the Epworth Sleepiness questionnaire to measure sleepiness. | At baseline, at 6 weeks, and in the treatment arm at 12 weeks. | 
| Change in blood pressure from baseline to 6 weeks | The investigators will measure seated blood pressure in triplicate and use the average of the latter two readings for blood pressure (taken at baseline and 6 week visits). | At baseline and at 6 weeks | 
| Change in heart rate from baseline to 6 weeks | The investigators will measure seated heart rate in triplicate and use the average of the latter two readings for heart rate(taken at baseline and 6 week visits). | At baseline and at 6 weeks | 
| Change in Quality of life at baseline and 6 weeks | The investigators will measure this using the Duke Health Profile, another validated questionnaire to measure quality of life. | At baseline, at 6 weeks, and in the treatment arm at 12 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive behavioral therapy for insomnia, randomized controlled trial