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Completed

NCT Number: NCT02848859

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).

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Key information

Conditions

Insomnia Cardiovascular Diseases Coronary Disease Coronary Heart Disease Dyssomnias Heart Diseases Mental Disorders Myocardial Ischemia Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Go! to Sleep

Behavioral

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

Other names: web-based cognitive behavioral therapy

General sleep education

Behavioral

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

Primary outcomes

  1. Change from baseline Insomnia Severity Index score at 6 weeks

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

    It is a 7 item, validated questionnaire to determine severity of insomnia symptoms.

Secondary outcomes

  1. Change in sleep duration from baseline to 6 weeks

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

  2. Change in mood assessed using the Patient Health Questionnaire-8 from baseline to 6 weeks

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

    The investigators will use the Patient Health Questionnaire-8 to measure depressive symptoms

  3. Change in sleepiness assessed using the Epworth Sleepiness Questionnaire from baseline to 6 weeks

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

    The investigators will use the Epworth Sleepiness questionnaire to measure sleepiness.

  4. Change in blood pressure from baseline to 6 weeks

    Time frame: At baseline and at 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).

  5. Change in heart rate from baseline to 6 weeks

    Time frame: At baseline and at 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).

  6. Change in Quality of life at baseline and 6 weeks

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

    The investigators will measure this using the Duke Health Profile, another validated questionnaire to measure quality of life.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • The Cleveland Clinic

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jul 29, 2016
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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