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 Sex
All
Accepts Healthy Volunteers
No

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

Study Design

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

Arm Groups

ArmDescriptionAssigned 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