Improving Sleep for Healthy Hearts

Insomnia Clinical Trial

Official title: Improving Sleep for Healthy Hearts

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Insomnia
• Myocardial Ischemia
• Sleep Initiation and Maintenance Disorders

• NCT number: NCT02848859
• Study type: Interventional
• Source: Brigham and Women's Hospital
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Completion date: December 2016