NIH Reporter #5R33HL164688-04

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

A NIH-funded trial to evaluate behavioral treatments for insomnia among socioeconomically disadvantaged adults in primary care, comparing BBTI and CBTI effectiveness and implementation over 52 weeks.

Description

This study aims to compare how well two proven non-drug treatments treat insomnia in 350 adults of lower income and/or racial and ethnic groups seen in primary care. It includes a foreign component involving international expert consultation for intervention protocol adaptation, clinician training materials, and dissemination. The project involves a 52-week effectiveness-implementation trial enrolling 350 primary care patients with insomnia who are eligible for insurance through programs like Medicaid, speak Spanish, or belong to racial/ethnic groups. The hypothesis is that Behavioral Behavioral Treatment for Insomnia (BBTI) will be non-inferior to Cognitive Behavioral Therapy for Insomnia (CBTI) at 3 months. Secondary outcomes include quality of life, depression, sleep duration and efficiency, hypnotic use, and adverse events. The study will explore effects at 6 and 12 months and use the Consolidated Framework for Implementation Research to examine contextual factors influencing implementation. This work aims to advance treatment for underserved groups and align with the goals of the funding opportunity.

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