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

Description

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.

Conditions

Insomnia

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Insomnia
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

Study Record Dates

2027-06