Improving Sleep for Healthy Hearts

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).

Study Overview

• Status: Completed
• Conditions: Insomnia; Coronary Heart Disease
• Intervention / Treatment: Behavioral: Go! to Sleep; Behavioral: General Sleep Education

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: The Cleveland Clinic
• Investigators: Principal Investigator: Susan Redline, MD, MPH, Brigham and Women's Hospital; Study Director: Sogol Javaheri, MD, MA, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: randomized controlled trial; cognitive behavioral therapy for insomnia
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2014P000845