Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT02929069
Brief Summary:
The intent of the proposed randomized controlled trial is to test the efficacy of a principle-based, transdiagnostic cognitive behavioral therapy (CBT) intervention that addresses the pathways through which minority stress compromises young gay and bisexual men's (YGBM) co-occurring mental (e.g., depression), behavioral (e.g., substance use), and sexual (e.g., condomless anal sex) health problems.
Detailed Description:
ESTEEM (Effective Skills to Empower Effective Men) is a 10-session skills-building intervention designed to reduce young gay and bisexual men's (YGBM) co-occurring health risks by reducing the underlying cognitive, affective, and behavioral pathways through which minority stress impairs YGBM's health. ESTEEM is based on the Unified Protocol, a cognitive-behavioral therapy (CBT) approach with efficacy across mental health and risk behaviors. In an initial study to create ESTEEM , the Unified Protocol was adapted by conducting interviews with 21 YGBM-expert mental health providers and 20 depressed, anxious YGBM at high risk for HIV infection. In a preliminary trial (NCT02448186), ESTEEM significantly reduced YGBM's spectrum of interrelated health threats, making it the first evidence-based intervention to simultaneously improve mental health, substance use, and sexual health outcomes among YGBM.
Important questions remain in order to validate the efficacy and potential cost-effectiveness of ESTEEM. Accordingly, we propose a 3-arm RCT that would examine (1) whether ESTEEM (arm 1) demonstrates significant improvements compared to existing LGBT-affirmative community mental health treatment (CMHT; arm 2) or standard HIV/STD voluntary counseling and testing (VCT; arm 3) for high-risk depressed and anxious YGBM and (2) whether it improves outcomes through reducing hypothesized cognitive, affective, and behavioral minority stress processes.
Study:
NCT02929069
Study Brief:
Protocol Section:
NCT02929069