Integrative Cardiac Health Project Cognitive-Behavior Therapy for Insomnia

Stopped early · Not applicable

Conditions studied: Insomnia, Cardiovascular Risk Factor

In brief

This study investigates the feasibility, acceptability, and effectiveness of adding Cognitive-Behavioral Therapy for Insomnia (CBT-I) to the standard care received at the Integrative Cardiac Health Project (ICHP) on insomnia symptoms and severity. ICHP is an established cardiovascular disease prevention program to reduce cardiovascular disease risk through the adoption of lifestyle changes related to improvements in diet, stress, sleep, and exercise. The study will be conducted among patients with insomnia who are already enrolled in the ICHP cardiovascular risk prevention program. This is a single-center study, prospective, randomized, controlled, interventional trial within ICHP at the Walter Reed National Military Medical Center (WRNMMC). To conduct both phases of the study, up to 76 total male and female patients enrolled in ICHP who meet criteria for insomnia will be recruited. Participants who meet inclusion and exclusion criteria for this study, and consent to participate, will be randomized to one of two conditions: (1) ICHP, or (2) ICHP + CBT-I treatment. CBT-I treatment will consist of four in-person appointments and two telephone appointments.

Key facts

Study ID

NCT02779023

Run by

Walter Reed National Military Medical Center

People needed

6

Starts

2015-10-29

Expected to finish

2016-07-11

Last updated by the study team

2018-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 or older, Tricare beneficiary, participation in ICHP
• Sleep-onset or maintenance insomnia, defined as sleep-onset latency (SOL; time it takes to fall asleep) and/or wake after sleep onset (WASO; time spent awake after falling asleep) longer than 30 minutes per night at least 3 nights per week
• Insomnia duration of at least 3 months
• A complaint of at least 1 negative effect during waking hours (e.g., fatigue, impaired functioning, mood disturbances) that is attributed to insomnia
• Score of 8 or greater on the Insomnia Severity Index
• Pittsburgh Sleep Quality Index (PSQI) score of > 5

You may not qualify if…

• Previous participation in the ICHP program
• Use of stimulant medications or acute high dose of steroids
• Suicidal ideation, as determined by a score of 1 or greater on question #9 of the Patient Health Questionnaire-9 (PHQ-9)
• Concurrent psychological or behavioral treatment for insomnia
• Current pregnancy by history, or plans to become pregnant in the next 6 months (excluded because of sleep difficulties which often occur during pregnancy that could confound the results)

Where it is running

• Integrative Cardiac Health Project, Walter Reed National Military Medical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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