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NCT Number: NCT05759065

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

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Carolina Dos Santos

CONTACT

617-278-0746

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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-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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Insomnia severity index, ISI

    Time frame: 6- and 12-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).

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

    Time frame: 3-months

    The PROMIS Global Health measures assess an individual's physical, mental and social health. The measure produces two scores: Physical and Mental Health from 4 items each. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.

  3. Quality of Life and Symptoms - Generic-quality of life

    Time frame: 3-months

    Generic-quality of life will be assessed by the change in the Euroqol - 5 Dimensions (EQ-5D) questionnaire. The questionnaire comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. There is no total score or range.

  4. Generalized Anxiety Disorder (GAD-7)

    Time frame: 3-months

    GAD-7 measures self-reported anxiety disorder. The measure includes 7-items with higher scores indicating anxiety. The minimum score is 0 and the maximum score is 21.

  5. Patient Health Questionnaire for depression (PHQ-8)

    Time frame: 3-months

    PHQ-8 measures self-reported current depression. The measure includes 8-items with higher scores indicating depression. The minimum score is 0 and the maximum score is 24.

  6. Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Impairment, 8a

    Time frame: 3-months

    PROMIS Sleep Impairment measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness during the past seven days. The measure includes 8-items with higher scores indicating greater sleep impairment. The minimum score is 8 and the maximum score 40. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.

  7. Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b

    Time frame: 3-months

    PROMIS Sleep Disturbance measures self-reported sleep quality and associated daytime functioning during the past seven days. The measure includes 8-items with higher scores indicating greater sleep disturbance. The minimum score is 8 and the maximum score is 40. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.

  8. Diary reported sleep duration

    Time frame: 3-months

    Self-reported sleep duration with be measured using sleep diary

  9. Diary-reported sleep efficiency

    Time frame: 3-months

    Self-reported sleep efficiency with be measured using sleep diary

  10. Number of participants with hypnotic use self-reported from the sleep diary

    Time frame: 3-months

    Hypnotic use will be measured by the number of participants who self-reported use on the sleep diary

Study contacts

Contact information is provided by the study sponsor or research team.

Suzanne Bertisch, MD, MPH

CONTACT

[email protected]

857-307-0355

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 8, 2023
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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