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Improving Sleep for Healthy Hearts

Primary Purpose

Insomnia, Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Go! to Sleep
General Sleep Education
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring cognitive behavioral therapy for insomnia, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Brigham and Womens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention: Go! to Sleep

General Sleep Hygiene Education

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change from baseline Insomnia Severity Index score at 6 weeks
It is a 7 item, validated questionnaire to determine severity of insomnia symptoms.

Secondary Outcome Measures

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.
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
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.
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).
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).
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.

Full Information

First Posted
July 22, 2016
Last Updated
February 22, 2017
Sponsor
Brigham and Women's Hospital
Collaborators
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02848859
Brief Title
Improving Sleep for Healthy Hearts
Official Title
Improving Sleep for Healthy Hearts
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Coronary Heart Disease
Keywords
cognitive behavioral therapy for insomnia, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Go! to Sleep
Arm Type
Active Comparator
Arm 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.
Arm Title
General Sleep Hygiene Education
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Go! to Sleep
Other Intervention Name(s)
web-based cognitive behavioral therapy
Intervention Description
This is an online interactive program that delivers cognitive behavioral therapy for insomnia via the internet.
Intervention Type
Behavioral
Intervention Name(s)
General Sleep Education
Intervention Description
Providing patients information on healthy sleep and habits to promote healthy sleep.
Primary Outcome Measure Information:
Title
Change from baseline Insomnia Severity Index score at 6 weeks
Description
It is a 7 item, validated questionnaire to determine severity of insomnia symptoms.
Time Frame
At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Secondary Outcome Measure Information:
Title
Change in sleep duration from baseline to 6 weeks
Description
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.
Time Frame
At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Title
Change in mood assessed using the Patient Health Questionnaire-8 from baseline to 6 weeks
Description
The investigators will use the Patient Health Questionnaire-8 to measure depressive symptoms
Time Frame
At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Title
Change in sleepiness assessed using the Epworth Sleepiness Questionnaire from baseline to 6 weeks
Description
The investigators will use the Epworth Sleepiness questionnaire to measure sleepiness.
Time Frame
At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Title
Change in blood pressure from baseline to 6 weeks
Description
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).
Time Frame
At baseline and at 6 weeks
Title
Change in heart rate from baseline to 6 weeks
Description
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).
Time Frame
At baseline and at 6 weeks
Title
Change in Quality of life at baseline and 6 weeks
Description
The investigators will measure this using the Duke Health Profile, another validated questionnaire to measure quality of life.
Time Frame
At baseline, at 6 weeks, and in the treatment arm at 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Redline, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sogol Javaheri, MD, MA
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Brigham and Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Improving Sleep for Healthy Hearts

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