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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two types of behavioral treatments for insomnia among socioeconomically disadvantaged adults in primary care. The study aims to test whether tele-Brief Behavioral Treatment for Insomnia BBTI is not less effective than tele-Cognitive-Behavioral Therapy for Insomnia CBTI. The trial focuses on adults diagnosed with insomnia, particularly those facing socioeconomic challenges, to find accessible treatment options. The study compares two telehealth interventions BBTI, which involves up to five weekly phone sessions delivered by various practitioners without formal sleep training, and CBTI, a more comprehensive therapy conducted by trained mental health clinicians over 6 to 12 weeks. Participants are randomly assigned to one of these two groups to receive the respective treatment remotely. Participants will be monitored over several months, with primary outcomes measured by the Insomnia Severity Index at 3 months. Secondary outcomes include insomnia severity at 6 and 12 months, quality of life assessments, anxiety and depression measures, sleep impairment and disturbance scales, sleep diary reports, and hypnotic medication use. The study tracks these outcomes through patient-reported questionnaires and sleep diaries to evaluate treatment effects and overall health impact.
CONDITIONS
Brief 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 greater than 10
- Eligible to receive care through publicly-supported medical assistance 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 or drug abuse
- Excessive daytime sleepiness (Epworth Sleepiness Scale score ≥ 16)
- Seizure within the past 1 year
- Main sleep period outside of 8pm - 11am
- Regular night shift work (5 overnight shifts/month between midnight-5am)
- Untreated moderate to severe sleep apnea
- Severe medical condition requiring possible hospitalization in next 6 months
- Active suicidal ideation during screening
- Pregnant or planning to become pregnant
- Participation in other studies affecting intervention benefit or safety as determined by the study PI
Research Team
S
Suzanne Bertisch, MD, MPH
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