A Unified Intervention for Young Gay and Bisexual Men's Minority Stress, Mental Health, and HIV Risk
Condition: HIV; Acquired Immunodeficiency Syndrome
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional

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.
    

Intervention name(s): ESTEEM; CMHT; VCT
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.; CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.; Voluntary Counselling and Testing (VCT).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Minority Stress