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

Recruiting
18 years of age
Both
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
  • 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 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 details

Insomnia

NCT05759065

Brigham and Women's Hospital

13 April 2024

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