A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
NCT ID: NCT05759065
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
350 participants
INTERVENTIONAL
2024-04-02
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tele-Brief Behavioral Treatment for Insomnia
Tele-Brief Behavioral Treatment for Insomnia
Brief Behavioral Treatment for Insomnia (BBTI) comprises of up to five weekly intervention visits by phone, delivered by a variety of practitioners without formal training in sleep.
Tele-Cognitive-Behavioral Therapy for Insomnia
Tele-Cognitive-Behavioral Therapy for Insomnia
Cognitive-Behavioral Therapy for Insomnia (CBTI) is a multicomponent strategy delivered by trained mental health clinicians over 6 to 12 weeks.
Interventions
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Tele-Brief Behavioral Treatment for Insomnia
Brief Behavioral Treatment for Insomnia (BBTI) comprises of up to five weekly intervention visits by phone, delivered by a variety of practitioners without formal training in sleep.
Tele-Cognitive-Behavioral Therapy for Insomnia
Cognitive-Behavioral Therapy for Insomnia (CBTI) is a multicomponent strategy delivered by trained mental health clinicians over 6 to 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Suzanne M. Bertisch, MD, MPH
Associate Physician, Clinical Director of Behavioral Sleep Medicine
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Carolina Dos Santos
Role: primary
Other Identifiers
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2023P000106
Identifier Type: -
Identifier Source: org_study_id
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