A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care

Last updated: April 2, 2024
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Treatment

Tele-Cognitive-Behavioral Therapy for Insomnia

Tele-Brief Behavioral Treatment for Insomnia

Clinical Study ID

NCT05759065
2023P000106
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18 years or older
  • Meet clinical diagnostic criteria for insomnia
  • Insomnia severity score > 10
  • Eligible to receive care through publicly supported medical assistance, OR
  • Identify as race or ethnic minority
  • Has capacity for informed consent

Exclusion

Exclusion Criteria:

  • Untreated, current major depressive disorder
  • History of bipolar or psychosis
  • Active substance abuse or drug abuse
  • Excessive daytime sleepiness
  • Seizure within the past 1 year
  • Main sleep period outside of 8pm - 11am
  • Regular nightshift work
  • 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

Study Design

Total Participants: 350
Treatment Group(s): 2
Primary Treatment: Tele-Cognitive-Behavioral Therapy for Insomnia
Phase:
Study Start date:
April 02, 2024
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

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