Document text
Principal Investigator: Suzanne Bertisch
Organization: BRIGHAM AND WOMEN'S HOSPITAL
Fiscal Year: 2024
Award: $590,643
Funding agency: National Heart Lung and Blood Institute
ABSTRACT
Insomnia, present among 15-25% of low-income adults and other overlapping socioeconomically
disadvantaged groups such as racial/ethnic minorities, is frequently undertreated, impairs quality of life, and is
associated with increased risk for depression, cardiovascular disease, and premature mortality. Our long-term
goal is to test the dissemination and implementation of evidence-based treatments for insomnia for
socioeconomically disadvantaged adults who face insomnia care inequities. Cognitive-behavioral therapy for
insomnia (CBTI) is recommended as first-line treatment. However, CBTI’s real-world adoption is constrained
by a limited number of specialty-trained clinicians, treatment time, costs, and language barriers. Brief
behavioral treatment for insomnia (BBTI) was developed to expand CBTI’s reach by reducing the time burden
(1.5 vs 6 hours) of treatment and clinician training while harnessing the broad workforce and embedded
payment models of routine medical settings, such as primary care. Thus, BBTI offers a scalable solution for
delivering CBTI’s core behavioral components to socioeconomically disadvantaged patients, who face the
greatest barriers to accessing CBTI and have been underrepresented in insomnia research. This study is
supported by evidence demonstrating BBTI’s short-term efficacy in improving insomnia outcomes. However,
BBTI’s effects have not been adequately compared to CBTI. This application proposes to fill this gap by testing
the non-inferiority of BBTI compared to CBTI on insomnia and insomnia-related outcomes in a low-income,
diverse sample receiving care in community and academic-based primary clinics across a single site. During
the one-year R61 start-up phase, we will conduct foundational work to ensure the R33 clinical trial phase is
launched expeditiously and optimally structured to efficiently engage all partners and our target patient population
and meet recruitment milestones. The R33 phase consists of a 52-week effectiveness-implementation trial
enrolling 350 primary care patients with insomnia who are eligible to receive insurance through a medical
assistance program (e.g., Medicaid), speak Spanish, or represent a racial or ethnic minority. We hypothesize
that BBTI will be non-inferior to CBTI (defined by a non-inferiority margin of 4 points on the insomnia severity
index) at 3-months. Secondary outcomes will include quality-of-life; depression; and diary-reported sleep
duration and efficiency; hypnotic use; and adverse events. We will also explore the durability of effects at 6 and
12 months. We will use the Consolidated Framework for Implementation Research to explore patient- and
clinic-level contextual factors influencing implementation to inform future strategies. By concurrently testing the
effectiveness and investigating implementation factors, this proposal will lay the foundation for subsequent
implementation trials testing the broad uptake of evidence-based behavioral insomnia treatments. Thus, the
information gained for the proposed work would directly advance the treatment of insomnia for underserved
groups along the translational continuum, strongly aligning with the goals of this RFA.
Terms: <21+ years old><Abbreviations><Address><Administrator><Adoption><Adult><Adult Human><Adverse Experience><Adverse event><Application Context><Behavior Conditioning Therapy><Behavior Modification><Behavior Therapy><Behavior Treatment><Behavioral><Behavioral Conditioning Therapy><Behavioral Modification><Behavioral Therapy><Behavioral Treatment><Biometrics><Biometry><Biostatistics><Cardiovascular Diseases><Caring><Clinic><Clinical><Clinical Research><Clinical Study><Clinical Trials><Cognition Therapy><Cognitive Disturbance><Cognitive Impairment><Cognitive Psychotherapy><Cognitive Therapy><Cognitive decline><Cognitive function abnormal><Cognitive treatment><Communities><Conditioning Therapy><Consolidated Framework for Implementation Research><Consolidated Framework for Implementation Science><Consolidated Framework for Implementing Change><Data><Data Collection><Diagnosis><Disparities><Disparity><Dissemination and Implementation><Disturbance in cognition><Drug Therapy><Economic Income><Economical Income><Economically Deprived Population><Eligibility><Eligibility Determination><Employee><Ensure><Espanol><Evidence based treatment><Foundations><Future><Goals><Guidelines><Health><Health Inequity><History><Hospitals><Hour><Household><Impaired cognition><Impairment><Income><Inequalities in Health><Inequities in Health><Inequity><Infrastructure><Insomnia><Insomnia Disorder><Insurance><Intervention><Intervention Strategies><Interview><Knowledge><Language><Low Income Population><Low income><Low income group><Major Depressive Disorder><Medicaid><Medical><Medical Assistance><Medical Directors><Mental Depression><Mental Health><Mental Hygiene><Modeling><Non-pharmacologic Therapy><Nonpharmacologic Intervention><Nonpharmacologic Therapy><Nonpharmacologic approach><Nonpharmacologic treatment><Nurse Practitioners><Outcome><Participant><Patients><Persons><Pharmacotherapy><Phase><Phone><Physician Executives><Premature Mortality><Preventive><Primary Care><Protocol><Protocol Screening><Protocols documentation><Psychological Health><QOL><Quality of life><Randomization trial><Recommendation><Recording of previous events><Reporting><Research><Research Design><Risk><Risk Factors><Sampling><Severities><Site><Sleep><Sleep Disorders><Sleeplessness><Social Workers><Socioeconomically disadvantaged><Spanish><Specialty><Structure><Study Type><Symptoms><Telephone><Testing><Time><Training><Underserved Population><United States><Woman><Work><acceptability and feasibility><adulthood><adverse consequence><adverse outcome><arm><behavior intervention><behavioral intervention><burden of disease><burden of illness><cardiovascular disease risk><cardiovascular disorder><cardiovascular disorder risk><clinical depression><cognitive behavior intervention><cognitive behavior modification><cognitive behavior therapy><cognitive behavioral intervention><cognitive behavioral modification><cognitive behavioral therapy><cognitive behavioral treatment><cognitive dysfunction><cognitive loss><compare treatment><contextual factors><cost><depression><diaries><disease burden><drug treatment><economically deprived group><economically deprived people><economically disadvantaged group><economically disadvantaged individual><economically disadvantaged people><economically disadvantaged population><effectiveness and implementation trial><effectiveness testing><effectiveness-implementation randomized trial><effectiveness/implementation hybrid trial><effectiveness/implementation trial><ethnic minority><ethnic minority group><ethnic minority individual><ethnic minority people><ethnic minority population><evidence base><experience><future implementation><health inequalities><health related quality of life><histories><hypnotic><implementation determinants><implementation factors><implementation science><implementation trial><improved><incomes><indexing><informant><interventional strategy><low income individual><low income people><major depression><major depression disorder><medical specialties><mortality><multidisciplinary><non-drug therapy><non-drug treatment><nondrug therapy><nondrug treatment><patient population><payment><physical conditioning><physical health><pilot test><post intervention><primary care clinic><primary care patient><primary care setting><primary outcome><programs><quality of sleep><racial minority><racial minority group><racial minority individual><racial minority people><racial minority population><randomized effectiveness trial><randomized trial><recruit><secondary outcome><side effect><sleep diseases><sleep dysfunction><sleep health><sleep hygiene><sleep illness><sleep onset><sleep problem><sleep quality><socio-economic disadvantage><socio-economically disadvantaged><socio-economically underprivileged><socioeconomic disadvantage><socioeconomically underprivileged><study design><telehealth><treatment comparison><trial enrollment><under served group><under served individual><under served people><under served population><underclass><underserved group><underserved individual><underserved people><uptake>