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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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 details
    Insomnia

NCT05759065

Brigham and Women's Hospital

14 May 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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