RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-02
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05759065

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18 years or older
  2. * Meet clinical diagnostic criteria for insomnia
  3. * Insomnia severity score \> 10
  4. * Eligible to receive care through publicly supported medical assistance, OR
  5. * Identify as race or ethnic minority
  6. * Has capacity for informed consent
  1. * Untreated, current major depressive disorder
  2. * History of bipolar or psychosis
  3. * Active substance abuse or drug abuse
  4. * Excessive daytime sleepiness
  5. * Seizure within the past 1 year
  6. * Main sleep period outside of 8pm - 11am
  7. * Regular nightshift work
  8. * Untreated, previously diagnosed moderate to severe sleep apnea
  9. * Severe medical condition, which may require hospitalizations over the next 6 months
  10. * Active suicidal ideation, if elicited passively during screening
  11. * Pregnant or planning to become pregnant

Contacts and Locations

Study Contact

Suzanne Bertisch, MD, MPH
CONTACT
857-307-0355
sbertisch@bwh.harvard.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-02
Study Completion Date2027-06

Study Record Updates

Study Start Date2024-04-02
Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

  • Insomnia