MedTrace Logo

Integrative Cardiac Health Project Cognitive-Behavior Therapy for Insomnia

NCT02779023 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-09-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Cognitive-Behavior Therapy for Insomnia (CBT-I)

Sponsors & Collaborators

  • Uniformed Services University of the Health Sciences

    collaborator FED

  • Walter Reed National Military Medical Center

    lead FED

Principal Investigators

  • Todd C Villines, MD · Walter Reed National Military Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-29
Primary Completion
2016-07-11
Completion
2016-07-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02779023 on ClinicalTrials.gov