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

NCT05759065 | Recruiting DMC

• 1 other identifier: 2023P000106
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Insomnia severity index, ISI

  The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).

  3 months

Secondary Outcomes (10)

• Insomnia severity index, ISI

  6- and 12-months

• Quality of Life and Symptoms - Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health

  3-months

• Quality of Life and Symptoms - Generic-quality of life

  3-months

• Generalized Anxiety Disorder (GAD-7)

  3-months

• Patient Health Questionnaire for depression (PHQ-8)

  3-months

Study Arms (2)

Tele-Brief Behavioral Treatment for Insomnia

EXPERIMENTAL

Behavioral: Tele-Brief Behavioral Treatment for Insomnia

Tele-Cognitive-Behavioral Therapy for Insomnia

ACTIVE COMPARATOR

Behavioral: Tele-Cognitive-Behavioral Therapy for Insomnia

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-Brief Behavioral Treatment for Insomnia

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.

Tele-Cognitive-Behavioral Therapy for Insomnia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Suzanne Bertisch, MD, MPH

CONTACT

857-307-0355; sbertisch@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician, Clinical Director of Behavioral Sleep Medicine

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 8, 2023
• Study Start: April 2, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)