# A hybrid effectiveness-implementation trial evaluating behavioral treatments for insomnia for socioeconomic disadvantaged adults in primary care

> **NIH NIH R61** · BRIGHAM AND WOMEN'S HOSPITAL · 2022 · $562,951

## Abstract

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. T...

## Key facts

- **NIH application ID:** 10507411
- **Project number:** 1R61HL164688-01
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Suzanne Bertisch
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $562,951
- **Award type:** 1
- **Project period:** 2022-09-20 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10507411

## Citation

> US National Institutes of Health, RePORTER application 10507411, A hybrid effectiveness-implementation trial evaluating behavioral treatments for insomnia for socioeconomic disadvantaged adults in primary care (1R61HL164688-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10507411. Licensed CC0.

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