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

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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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

350 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Suzanne Bertisch, MD, MPH

Data sourced from clinicaltrials.gov

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