NCT05759065 A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
| NCT ID | NCT05759065 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brigham and Women's Hospital |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2024-04-02 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 350 participants in total. It began in 2024-04-02 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05759065 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05759065 currently recruiting?
Yes, NCT05759065 is actively recruiting participants. Contact the research team at sbertisch@bwh.harvard.edu for enrollment information.
Where is the NCT05759065 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05759065 clinical trial?
NCT05759065 is sponsored by Brigham and Women's Hospital. The trial plans to enroll 350 participants.
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