Chronic insomnia is among the most reported complaints of Veterans and military personnel, especially those referred for mental health services. Insomnia is highly comorbid with medical and psychiatric disorders, and is associated with significantly increased healthcare utilization and costs. Despite this impact, insomnia remains under-treated. When identified, insomnia is typically treated in primary care with pharmacotherapy, rather than evidence-based psychotherapies (EBPs), like Cognitive Behavioral Therapy for Insomnia (CBTI) and Brief Behavioral Treatment for Insomnia (BBTI). However, a number of system-, provider-, patient-, and treatment-level barriers contribute to the under-treatment and inadequate access to EBPs. To increase access to care, key advantages of BBTI versus CBTI is that it is briefer and offers a flexible treatment delivery (in-person + phone) if BBTI could be successfully implemented and integrated into primary care settings. Although efficacious, it is not yet known if BBTI achieves the same clinical outcomes as CBTI, the standard of care in the VA. Furthermore, it is necessary to identify patient, provider, and system level factors that will impact successful implementation. To increase the viability of EBPs for insomnia in the VA, it is critical to determine which treatments are most effective, and which implementation factors impact the uptake and integration into practice.
The aims are (1) to directly compare two EBPs for insomnia, CBTI vs. BBTI, and (2) to conduct a qualitative needs assessment in order to identify the barriers and facilitators that will impact efforts to implement and integrate brief treatments for insomnia.
This is a Hybrid Type 1 trial. Aim 1 is a randomized clinical trial of CBTI vs. BBTI. The recruitment target is 56 Veterans with chronic insomnia (n=28/treatment arm; anticipate 25% attrition). Non-inferiority analysis will compare mean change score on the Insomnia Severity Index (ISI) from baseline to post-treatment between treatments. Non-inferiority will be estimated if the 95% confidence interval of the BBTI ISI change score is less than the non-inferiority margin of CBTI, as determined by the Reliable Change Index. For Aim 2, qualitative interviews will be conducted with Veterans from Aim 1 as well as primary care providers and nurses (n=8-12 per group; n=32-48 total). The Consolidated Framework for Implementation Research (CFIR) informed the development of the interviews and an open iterative coding approach will identify CFIR factors, themes, and additional implementation elements that arise through the coding process.
Not yet available.
This project may help to increase access to evidence-based, brief behavioral insomnia care. By improving access, the risks and burdens associated with chronic insomnia, including comorbid psychiatric symptoms, prescription sleep medication use, and healthcare utilization may be decreased.
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Mental, Cognitive and Behavioral Disorders, Health Systems
Treatment - Comparative Effectiveness