A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
Brigham and Women's Hospital
350 participants
Apr 2, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- Aged 18 years or older
- Meet clinical diagnostic criteria for insomnia
- Insomnia severity score > 10
- Eligible to receive care through publicly supported medical assistance, OR
- Identify as race or ethnic minority
- Has capacity for informed consent
Exclusion Criteria11
- Untreated, current major depressive disorder
- History of bipolar or psychosis
- Active substance abuse or drug abuse
- Excessive daytime sleepiness
- Seizure within the past 1 year
- Main sleep period outside of 8pm - 11am
- Regular nightshift work
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Brief Behavioral Treatment for Insomnia (BBTI) comprises of up to five weekly intervention visits by phone, delivered by a variety of practitioners without formal training in sleep.
Cognitive-Behavioral Therapy for Insomnia (CBTI) is a multicomponent strategy delivered by trained mental health clinicians over 6 to 12 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05759065