A randomized trial of acceptance-based behavioral therapy to improve mental health outcomes for LGBTQ plus persons: Study protocol

Background: During the COVID-19 pandemic, public health measures limited social interactions as an effective and protective intervention for all. For many, however, this social isolation exacerbated mental health symptoms. People who identify as lesbian, gay, bisexual, transgender, and queer (LGBTQ+) were already at elevated risk of anxiety and depression, relative to cisgender and heterosexual populations, and pandemic-related social isolation likely heightened these disparities. In our prior work with sexual and gender minorities, we developed and established feasibility and acceptability of a novel acceptance-based behavioral therapy (ABBT) intervention for HIV treatment. ABBT showed promise in improving social support and reducing mental health symptoms. In the current study, we investigate the efficacy of ABBT, compared to a treatment-as-usual control condition, in a full-scale randomized controlled trial to improve social support for LGBTQ+ persons living with anxiety and depression.Methods: Two hundred forty LGBTQ+ adults with anxiety and/or depressive symptoms will be recruited and equally randomized to receive: (a) the ABBT intervention, consisting of two 30-40 min sessions plus treatment -as-usual (TAU), or (b) TAU only. Primary outcomes are interviewer-assessed anxiety and depressive symptoms. Secondary outcomes are self-reported anxiety and depressive symptoms. Experiential avoidance and social support are hypothesized mediators and presence of an anxiety and/or depressive disorder is a hypothesized moderator.Conclusions: ABBT represents a novel, identify-affirming real-world approach to promoting social support as a means of improving mental health among individuals who identify as LGBTQ+. This study will contribute actionable data establishing the impact, mediational mechanisms, and effect modifiers of ABBT.Clinicaltrials.gov registration: NCT05540067