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NCT02779023: CBT-I

Integrative Cardiac Health Project Cognitive-Behavior Therapy for Insomnia

Terminated NA Last updated 11 September 2018
What this trial tests

NA trial testing Cognitive-Behavior Therapy for Insomnia (CBT-I) in Insomnia in 6 participants. Terminated before completion.

Timeline
29 October 2015
Primary endpoint
11 July 2016
11 July 2016

Quick facts

Lead sponsorWalter Reed National Military Medical Center
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment6
Start date29 October 2015
Primary completion11 July 2016
Estimated completion11 July 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Walter Reed National Military Medical Center

Who can join

18 and older, any sex, with Insomnia or Cardiovascular Risk Factor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Insomnia

Currently open trials in the same condition.

Other Walter Reed National Military Medical Center trials

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