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

Mass General Brigham

Status

Enrolling

Conditions

Insomnia

Treatments

Behavioral: Tele-Brief Behavioral Treatment for Insomnia

Behavioral: Tele-Cognitive-Behavioral Therapy for Insomnia

Study type

Interventional

Funder types

Other

Identifiers

NCT05759065

2023P000106

Details and patient eligibility

About

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.

Enrollment

350 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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