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Comparing remote behavioral treatments for insomnia in disadvantaged adults

Compares remote behavioral insomnia treatments in disadvantaged primary care adults.

Key facts

Who runs it
Brigham and Women's Hospital
Where
Boston, United StatesSee the site
Trial code
Registry title
A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
Status
Recruiting
People taking part
350 people, planned
Started
2 Apr 2024
Expected to end
Jun 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Tele-Brief Behavioral Treatment for Insomnia
  • Tele-Cognitive-Behavioral Therapy for Insomnia
Record updated
7 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with insomnia who get care in primary care and have low income or belong to a racial or ethnic minority. It compares two short behavioral sleep treatments given by video or phone.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
Insomnia that meets DSM-V diagnostic criteria, with an insomnia severity score > 10.

Main reasons for not taking part

  • Untreated, current major depression (PHQ-8≥ 20), active suicidal thoughts, or a history of bipolar disorder or psychosis.
  • Active alcohol or drug abuse.
  • Strong daytime sleepiness (Epworth score ≥ 16), untreated moderate to severe sleep apnea, a seizure in the past 1 year, or regular night shift work.
  • A severe illness that may need hospital stays over the next 6 months.
  • Being pregnant or planning to become pregnant.

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Untreated, previously diagnosed moderate to severe sleep apnea
  • 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)
  • Seizure within the past 1 year
  • Severe medical condition, which may require hospitalizations over the next 6 months
  • Excessive daytime sleepiness (Epworth Sleepiness Scale score ≥ 16)
  • Main sleep period outside of 8pm - 11am
  • Regular nightshift work (5 overnight shifts/month, defined as working between midnight-5am)
  • 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 in United States

  • Brigham and Women's HospitalBoston, United StatesContact: Carolina Dos SantosTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Tele-Brief Behavioral Treatment for InsomniaTreatment being tested
  • Tele-Cognitive-Behavioral Therapy for InsomniaExisting treatment, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
Plain-language title
Comparing remote behavioral treatments for insomnia in disadvantaged adultsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
7 May 2026