Actively Recruiting
A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
Led by Brigham and Women's Hospital · Updated on 2026-05-07
350
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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-Behavioral Therapy for Insomnia among socioeconomically disadvantaged adults with insomnia in the primary care setting.
CONDITIONS
Official Title
A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Meet clinical diagnostic criteria for insomnia (DSM-V criteria)
- Insomnia severity score > 10
- Eligible to receive care through publicly-supported medical assistance (e.g. Commonwealth Connector plan; MassHealth. For participants >65 years old on Medicare, they will be asked about insurance coverage prior to initiating Medicare, OR
- Identify as racial or ethnic minority
- Has capacity for informed consent (SDT<9)
You will not qualify if you...
- Untreated, current major depressive disorder (PHQ-8≥ 20)
- History of bipolar disorder or psychosis
- Active alcohol abuse (Alcohol Use Disorders Identification Test, AUDIT-C) or drug abuse (Drug Abuse Screening Test, DAST-2 ≥1)
- Excessive daytime sleepiness (Epworth Sleepiness Scale score ≥ 16)
- Seizure within the past 1 year
- Main sleep period outside of 8pm - 11am
- Regular nightshift work (5 overnight shifts/month, defined as working between midnight-5am)
- 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 (self-reported)
- Participation in other studies that may impact the benefit or safety of the intervention, as determined by the study PI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
S
Suzanne Bertisch, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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