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Recruiting NCT05759065

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

No phase Interventional Insomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tele-Brief Behavioral Treatment for Insomnia, Tele-Cognitive-Behavioral Therapy for Insomnia.
Who it may be relevant to
Registry conditions: Insomnia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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]
Secondary outcome measures (10)
  • Insomnia severity index, ISI [Time frame: 6- and 12-months]
  • Quality of Life and Symptoms - Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health [Time frame: 3-months]
  • Quality of Life and Symptoms - Generic-quality of life [Time frame: 3-months]
  • Generalized Anxiety Disorder (GAD-7) [Time frame: 3-months]
  • Patient Health Questionnaire for depression (PHQ-8) [Time frame: 3-months]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Impairment, 8a [Time frame: 3-months]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b [Time frame: 3-months]
  • Diary reported sleep duration [Time frame: 3-months]
  • Diary-reported sleep efficiency [Time frame: 3-months]
  • Number of participants with hypnotic use self-reported from the sleep diary [Time frame: 3-months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Brigham and Women's Hospital — Boston

Identifiers

NCT: NCT05759065 · 2023P000106

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗