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NCT03087799
Brief Behavioral Treatment for Sleep Problems in IBS Study
NA trial testing Brief Behavioral Treatment for Sleep in Irritable Bowel Syndrome in 25 participants. Completed in 8 August 2019.
8 August 2019
Quick facts
| Lead sponsor | Beth Israel Deaconess Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 3 March 2017 |
| Primary completion | 8 August 2019 |
| Estimated completion | 8 August 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Brief Behavioral Treatment for Sleep
Conditions studied
- Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →
- Sleep Disturbance — all drugs for Sleep Disturbance →
Sponsor
Beth Israel Deaconess Medical Center
Who can join
Adults 20 to 50, any sex, with Irritable Bowel Syndrome or Sleep Disturbance. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with Irritable Bowel Syndrome (IBS) often report more fatigue and sleep disturbances compared to their healthy counterparts and compared to patients with other GI disorders. This pilot study will evaluate the feasibility of a Brief Behavioral Treatment for Insomnia (BBT-I) in Irritable Bowel Syndrome. 40 participants will be recruited; 20 will receive 4 weeks of BBT and 20 will be assigned to a wait list control group (WLC). The primary aim of the current project is to assess feasibility of administering BBT-I to a sample of patients with IBS. Because behavioral sleep treatment has not yet been studied in IBS or any other GI population, this project will provide information about treatment adherence, recruitment, and effect sizes. Secondary aims include evaluating the impact of BBT-I on sleep quality and IBS symptom severity.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03087799
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Beth Israel Deaconess Medical Center trials
Trials by the same sponsor.
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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 NCT03087799 (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 Beth Israel Deaconess Medical Center
- Last refreshed: 4 March 2020
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/NCT03087799.
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