Improving Sleep for Healthy Hearts

NCT02848859 | Completed

• 1 other identifier: 2014P000845
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

Insomnia; Coronary Heart Disease

Keywords

cognitive behavioral therapy for insomnia; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in sleep duration from baseline to 6 weeks

  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

  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

  At baseline, at 6 weeks, and in the treatment arm at 12 weeks.

• Change in blood pressure from baseline to 6 weeks

  At baseline and at 6 weeks

• Change in heart rate from baseline to 6 weeks

  At baseline and at 6 weeks

Study Arms (2)

Intervention: Go! to Sleep

ACTIVE COMPARATOR

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; Behavioral: General Sleep Education

General Sleep Hygiene Education

PLACEBO COMPARATOR

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

Interventions

Go! to Sleep BEHAVIORAL

This is an online interactive program that delivers cognitive behavioral therapy for insomnia via the internet.

Also known as: web-based cognitive behavioral therapy

Intervention: Go! to Sleep

General Sleep Education BEHAVIORAL

Providing patients information on healthy sleep and habits to promote healthy sleep.

General Sleep Hygiene Education; Intervention: Go! to Sleep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Coronary Disease

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Susan Redline, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Sogol Javaheri, MD, MA

  Brigham and Women's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician, Division of Sleep and Circadian Disorders

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: July 29, 2016
• Study Start: March 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

US (1)