NCT05759065 · Brigham and Women's Hospital
A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
What this study is about
The overall objective of this study is to conduct a randomly assigned 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.
View original scientific 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.
Interventions
BEHAVIORAL
Tele-Brief Behavioral Treatment for Insomnia
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.
BEHAVIORAL
Tele-Cognitive-Behavioral Therapy for Insomnia
Cognitive-Behavioral Therapy for Insomnia (CBTI) is a multicomponent strategy delivered by trained mental health clinicians over 6 to 12 weeks.
Primary outcome measures
Insomnia severity index, ISI
Time frame: 3 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 7, 2026 · Source of record for eligibility and locations