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NCT02779023: CBT-I
Integrative Cardiac Health Project Cognitive-Behavior Therapy for Insomnia
NA trial testing Cognitive-Behavior Therapy for Insomnia (CBT-I) in Insomnia in 6 participants. Terminated before completion.
11 July 2016
Quick facts
| Lead sponsor | Walter Reed National Military Medical Center |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 29 October 2015 |
| Primary completion | 11 July 2016 |
| Estimated completion | 11 July 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Cognitive-Behavior Therapy for Insomnia (CBT-I)
Conditions studied
- Insomnia — all drugs for Insomnia →
- Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →
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.
Verify or expand the search:
- PubMed search for NCT02779023
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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- NCT06348082 — Project Women's Insomnia Sleep Health Equity Study (WISHES) · NA · recruiting
Other Walter Reed National Military Medical Center trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02779023 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Walter Reed National Military Medical Center
- Last refreshed: 11 September 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02779023.
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