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

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.

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