Recruiting

Behavioral Treatments

Sponsor:

Brigham and Women's Hospital

Code:

NCT05759065

Conditions

Insomnia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tele-Brief Behavioral Treatment for Insomnia

Tele-Cognitive-Behavioral Therapy for Insomnia

Study Details

Brief summary:

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

Insomnia

Study ID

NCT05759065

Start date

Apr 2, 2024

Status verified date

May, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tele-Brief Behavioral Treatment for Insomnia

active comparator: Tele-Cognitive-Behavioral Therapy for Insomnia

Interventions

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.

Primary outcome measure

  • Insomnia severity index, ISI [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Suzanne Bertisch, MD, MPH

857-307-0355sbertisch@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Carolina Dos Santos

617-278-0746

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

May 7, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-05-07.