Brigham Research Institute (BRI) - Brigham and Women's Hospital

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

Purpose

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

Insomnia

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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 Criteria

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Tele-Brief Behavioral Treatment for Insomnia		Behavioral: Tele-Brief Behavioral Treatment for Insomnia 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.
Active Comparator Tele-Cognitive-Behavioral Therapy for Insomnia		Behavioral: Tele-Cognitive-Behavioral Therapy for Insomnia Cognitive-Behavioral Therapy for Insomnia (CBTI) is a multicomponent strategy delivered by trained mental health clinicians over 6 to 12 weeks.

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02115

Contact:
Carolina Dos Santos
617-278-0746

More Details

Status: Recruiting
Sponsor: Brigham and Women's Hospital

Study Contact

Suzanne Bertisch, MD, MPH
857-307-0355
sbertisch@bwh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.