Improving Sleep for Healthy Hearts
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/24/2017 |
| Start Date: | March 2015 |
| End Date: | December 2016 |
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).
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).
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.
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.
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
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