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Behavioral Treatments for Insomnia in Primary Care

This study is looking at two behavioral treatments for insomnia in adults who have lower incomes and receive care through publicly-supported medical assistance. The treatments are called Tele-Brief Behavioral Treatment for Insomnia (BBTI) and Tele-Cognitive-Behavioral Therapy for Insomnia (CBTI). Researchers want to see if BBTI, which is delivered by phone by various practitioners, works just as well as CBTI, which is delivered by trained mental health clinicians. You might be able to join if you are 18 or older, have been diagnosed with insomnia, and have an insomnia severity score above 10. The study aims to enroll 350 people. We don't know the current recruitment status.

Study design
This is a randomized study comparing two behavioral treatments for insomnia. It plans to include 350 participants.
What's involved
Tele-Brief Behavioral Treatment for Insomnia involves up to five weekly phone visits. Tele-Cognitive-Behavioral Therapy for Insomnia is delivered over 6 to 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your insomnia severity will be measured at 3 months after starting treatment.

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NCT05759065

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

Recruiting
NAAges 18+InterventionalTreatment
Brigham and Women's Hospital
~350 participants
Updated 2026-05-07 on ClinicalTrials.gov
What's tested:Tele-Brief Behavioral Treatment for InsomniaTele-Cognitive-Behavioral Therapy for Insomnia

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Insomnia severity index, ISI
Measured over 3 months

Conditions

Insomnia

Explore related trials

Insomnia

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Suzanne Bertisch, MD, MPH
[email protected]
857-307-0355
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

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

What this trial measures

  • Insomnia severity index, ISI3 months

    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).