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

RecruitingNAAges 18 Years - anyAllBrigham and Women's Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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-8โ‰ฅ 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 โ‰ฅ1) * Excessive daytime sleepiness (Epworth Sleepiness Scale score โ‰ฅ 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
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What it tests

  • Tele-Brief Behavioral Treatment for Insomnia
  • Tele-Cognitive-Behavioral Therapy for Insomnia
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Where

1 site
Brigham and Women's Hospital
Boston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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