Status:
RECRUITING
A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Insomnia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The overall objective of this study is to conduct a randomized effectiveness-implementation trial to test the non-inferiority of tele-Brief Behavioral Treatment for Insomnia vs. tele-Cognitive-Behavio...
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years or older
- Meet clinical diagnostic criteria for insomnia
- Insomnia severity score > 10
- Eligible to receive care through publicly supported medical assistance, OR
- Identify as race or ethnic minority
- Has capacity for informed consent
Exclusion Criteria:
- Untreated, current major depressive disorder
- History of bipolar or psychosis
- Active substance abuse or drug abuse
- Excessive daytime sleepiness
- Seizure within the past 1 year
- Main sleep period outside of 8pm - 11am
- Regular nightshift work
- Untreated, previously diagnosed moderate to severe sleep apnea
- Severe medical condition, which may require hospitalizations over the next 6 months
- Active suicidal ideation, if elicited passively during screening
- Pregnant or planning to become pregnant
Key Trial Info
Start Date :
April 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT05759065
Start Date
April 2 2024
End Date
June 1 2027
Last Update
August 19 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115