Project ESTEEM protocol: a randomized controlled trial of an LGBTQ-affirmative treatment for young adult sexual minority men's mental and sexual health.

BACKGROUND: Young gay and bisexual men disproportionately experience depression, anxiety, and substance use problems and are among the highest risk group for HIV infection in the U.S. Diverse methods locate the source of these health disparities in young gay and bisexual men's exposure to minority stress. In fact, minority stress, psychiatric morbidity, substance use, and HIV risk fuel each other, forming a synergistic threat to young gay and bisexual men's health. Yet no known intervention addresses minority stress to improve mental health, substance use problems, or their joint impact on HIV risk in this population. This paper describes the design of a study to test the efficacy of such an intervention, called ESTEEM (Effective Skills to Empower Effective Men), a 10-session skills-building intervention designed to reduce young gay and bisexual men's co-occurring health risks by addressing the underlying cognitive, affective, and behavioral pathways through which minority stress impairs health. METHODS: This study, funded by the National Institute of Mental Health, is a three-arm randomized controlled trial to examine (1) the efficacy of ESTEEM compared to community mental health treatment and HIV counseling and testing and (2) whether ESTEEM works through its hypothesized cognitive, affective, and behavioral minority stress processes. Our primary outcome, measured 8 months after baseline, is condomless anal sex in the absence of PrEP or known undetectable viral load of HIV+ primary partners. Secondary outcomes include depression, anxiety, substance use, sexual compulsivity, and PrEP uptake, also measured 8 months after baseline. DISCUSSION: Delivering specific stand-alone treatments for specific mental, behavioral, and sexual health problems represents the current state of evidence-based practice. However, dissemination and implementation of this one treatment-one problem approach has not been ideal. A single intervention that reduces young gay and bisexual men's depression, anxiety, substance use, and HIV risk by reducing the common minority stress pathways across these problems would represent an efficient, cost-effective alternative to currently isolated approaches, and holds great promise for reducing sexual orientation health disparities among young men. TRIAL REGISTRATION: Registered October 10, 2016 to ClinicalTrials.gov Identifier: NCT02929069 .

LGBQ-affirmative cognitive-behavioral therapy for young gay and bisexual men's mental and sexual health: A three-arm randomized controlled trial.

OBJECTIVE: Effective Skills to Empower Effective Men (ESTEEM) represents the first intervention to address the psychological pathways through which minority stress undermines young sexual minority men's (SMM's) mental and sexual health using transdiagnostic cognitive-behavioral therapy. This study compared the efficacy of ESTEEM against two existing interventions. METHOD: Participants were young HIV-negative SMM (N = 254; ages = 18-35; 67.2% racial/ethnic minority) experiencing a depression, anxiety, and/or stress-/trauma-related disorder and past-90-day HIV transmission risk behavior. After completing HIV testing and counseling, participants were randomized to receive 10-session ESTEEM (n = 100); 10-session community-based LGBQ-affirmative counseling (n = 102); or only HIV testing and counseling (n = 52). RESULTS: For the primary outcome of any HIV transmission risk behavior at 8 months, ESTEEM was not significantly associated with greater reduction compared to HIV testing and counseling (risk ratio [RR] = 0.89, p = .52). Supportive analyses of the frequency of HIV transmission risk behavior at 8 months showed a nonsignificant difference between ESTEEM compared to HIV testing and counseling (RR = 0.69) and LGBQ-affirmative counseling (RR = 0.62). For secondary outcomes (e.g., depression, anxiety, substance use, suicidality, number of mental health diagnoses) at 8 months, ESTEEM had a larger effect size than the two comparison conditions, but these comparisons did not reach statistical significance when adjusting for the false discovery rate. Observed effect sizes for condition comparisons were smaller than the effect sizes used to power the study. In exploratory analyses, ESTEEM showed promise for reducing comorbidity. CONCLUSIONS: Because the control conditions were associated with stronger effects than anticipated, and given the heterogeneous nature of transdiagnostic outcomes, the study possessed insufficient power to statistically detect the consistently small-to-moderate benefit of ESTEEM compared to the two control conditions. (PsycInfo Database Record (c) 2022 APA, all rights reserved).