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NCT05759065NARecruiting

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

Brigham and Women's Hospital

Start Date

4/2/2024

Completion Date

6/1/2027

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

Age Range: 18 years to No maximum

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

Interventions

BEHAVIORAL

Tele-Brief Behavioral Treatment for Insomnia

BEHAVIORAL

Tele-Cognitive-Behavioral Therapy for Insomnia

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Conditions

Insomnia

Locations

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States