Equity-Focused Implementation of LGBTQ-Affirmative Cognitive Behavioral Therapy: A Hybrid Implementation-Effectiveness Trial

Background: Lesbian, gay, bisexual, transgender, non-binary, queer/questioning, and other sexual/gender minority (LGBTQ+) Veterans have disproportionate risk for poor mental health outcomes and suicide. Despite advances in VHA LGBTQ-affirmative care, systemic discrimination and barriers to accessing affirmative mental

health care continue to exacerbate mental health disparities. LGBTQ-Affirmative Cognitive Behavioral Therapy (CBT) is a unique intervention with a strong evidence base for improving mental health among LGBTQ+ individuals. This intervention is ready for implementation, but it has not yet been implemented widely in VHA.

Additionally, despite models and frameworks focusing on the intersection of health equity and implementation science, there is a lack of empirical evidence testing the impact of equity-focused implementation strategies. Significance: Points of significance include: 1) High rates of suicide among LGBTQ+ Veterans and few

evidence-based solutions for this population, 2) Focus on LGBTQ+ equity and collaboration/power-sharing, both of which are part of the VHA Strategic Plan, and 3) Strong partnerships with operations partners and Veteran-led community partners to enable quick action on study findings. Innovation & Impact: Points of innovation include: a) First known study to test implementation of an LGBTQ-

affirmative mental health treatment within VA or the broader community, b) Unique emphasis on power-sharing and participatory methods to incorporate health equity into rigorous implementation science methodology, and c) First known clinical trial to leverage a validated natural language processing-based algorithm to identify an

electronic, administrative cohort of LGBTQ+ Veterans to test effectiveness outcomes. Specific Aims: The objective of this project is to use a hybrid type III implementation-effectiveness trial design to test provider-level and Veteran-level outcomes associated with an Equity-Focused Implementation Package

to increase adoption and sustainment of LGBTQ-Affirmative CBT. The study includes the following specific aims: 1) to refine an Equity-Focused Implementation Package for improving uptake of LGBTQ-Affirmative CBT; 2a) To conduct a multi-site cluster-randomized trial of 12 facilities comparing a Standard Implementation

Package to an Equity-Focused Implementation Package; 2b) To qualitatively examine equity-related determinants of implementation across sites; and 3) To estimate the reach and effectiveness of the Equity- Focused Implementation Package among LGBTQ+ Veterans between implementation arms. Methodology: This cluster-randomized trial will include 12 facilities randomized 1-to-1 to receive either a

Standard Implementation Package (train-the-trainer, access to self-guided training, free treatment manuals, and national consultation calls) or an Equity-Focused Implementation Package (Standard Implementation plus 6 equity-focused implementation strategies). The primary implementation outcome is adoption, as measured

by the rate of psychotherapists delivering at least one session of LGBTQ-Affirmative CBT. Effectiveness outcomes include clinically significant change in depression (primary) and likelihood of self-injurious thoughts or behaviors (secondary). The study includes three key phases of implementation based on the EPIS

Framework (Exploration, Preparation, Implementation, Sustainment): refining the Equity-Focused Implementation Package using implementation mapping methodology with adaptations to incorporate power- sharing and equity focus; implementing the intervention using two separate, randomized implementation conditions; and removing external implementation to observe sustainment of the intervention.

Next Steps/Implementation: Dissemination and implementation activities will be carried out in partnership with the study Workgroup, operations partners, and Veteran-led community organizations, and will be directed within and outside of VHA. Additionally, the Equity-Focused Implementation Package will be considered as a

promising practice for widespread VHA implementation.