A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia
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.
| Condition(s) | Insomnia |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Brigham and Women's Hospital |
| Locations | Boston, Massachusetts, United States |
| Start date | 2024-04-02 |
| NCT ID | NCT05759065 |
| Official listing | https://clinicaltrials.gov/study/NCT05759065 |