Evaluating behavioral treatments for insomnia in disadvantaged adults
Official title: A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
Run by Brigham and Women's Hospital · NCT05759065 · Data updated 2026-11-12
This study is testing whether a shorter online treatment for insomnia works just as well as a more traditional therapy for people with low income who have trouble sleeping.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | April 2, 2024 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT05759065 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are socioeconomically disadvantaged adults aged 18 and older who meet the clinical diagnostic criteria for insomnia.
✕Probably not a fit
Patients with untreated major depressive disorder, active substance abuse, or severe medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare the effectiveness of tele-Brief Behavioral Treatment for Insomnia against tele-Cognitive-Behavioral Therapy for Insomnia among socioeconomically disadvantaged adults suffering from insomnia in a primary care setting. It is a randomized effectiveness-implementation trial designed to assess whether the brief treatment is non-inferior to the more established cognitive-behavioral therapy. Participants will be adults aged 18 and older who meet specific diagnostic criteria for insomnia and have a certain severity score. The study will take place at Brigham and Women's Hospital in Boston, Massachusetts.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and effective treatment option for insomnia in socioeconomically disadvantaged populations.
How similar studies have gone: Previous studies have shown success with cognitive-behavioral therapy for insomnia, but the specific comparison of brief behavioral treatment in this demographic is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Where it's running
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Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Suzanne Bertisch, MD, MPH
- Email: sbertisch@bwh.harvard.edu
- Phone: 857-307-0355
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.