Clinical trial NCT02848859: Improving Sleep for Healthy Hearts
Official title: Improving Sleep for Healthy Hearts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Coronary Heart Disease
Keywords: cognitive behavioral therapy for insomnia
randomized controlled trial
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
First posted: 2016-07-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline Insomnia Severity Index score at 6 weeks
timeFrame: At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Secondary outcomes:
measure: Change in sleep duration from baseline to 6 weeks
timeFrame: At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
measure: Change in mood assessed using the Patient Health Questionnaire-8 from baseline to 6 weeks
timeFrame: At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
measure: Change in sleepiness assessed using the Epworth Sleepiness Questionnaire from baseline to 6 weeks
timeFrame: At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
measure: Change in blood pressure from baseline to 6 weeks
timeFrame: At baseline and at 6 weeks
measure: Change in heart rate from baseline to 6 weeks
timeFrame: At baseline and at 6 weeks
measure: Change in Quality of life at baseline and 6 weeks
timeFrame: At baseline, at 6 weeks, and in the treatment arm at 12 weeks.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Susan Redline, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Sogol Javaheri, MD, MA
role: STUDY_DIRECTOR
References: