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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT05759065
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tele-Brief Behavioral Treatment for Insomnia — BEHAVIORAL
    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.
  • Tele-Cognitive-Behavioral Therapy for Insomnia — BEHAVIORAL
    Cognitive-Behavioral Therapy for Insomnia (CBTI) is a multicomponent strategy delivered by trained mental health clinicians over 6 to 12 weeks.

Study Details

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.

Key Dates

Start date
Apr 2, 2024
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tele-Brief Behavioral Treatment for Insomnia
  • Active Comparator: Tele-Cognitive-Behavioral Therapy for Insomnia

Primary Outcome Measure

Insomnia severity index, ISI [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Carolina Dos Santos
617-278-0746

Find similar trials in Boston, MA

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
Brigham and Women's Hospital· Boston, MA

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