A Unified Intervention for Young Gay and Bisexual Men's Minority Stress, Mental Health, and HIV Risk
| Status: | Recruiting |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 1/11/2019 |
| Start Date: | September 2016 |
| End Date: | August 2022 |
| Contact: | Oluwaseyi Adeyinka, MPH |
| Email: | oluwaseyi.adeyinka@yale.edu |
| Phone: | (646) 344-4060 |
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.
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.
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 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.
Inclusion Criteria:
- Identify as gay or bisexual.
- HIV-negative status.
- Diagnosis of any DSM depressive, anxiety, or trauma- and stressor-related disorder.
- HIV sexual risk (≥1 act of condomless anal with a male partner of unknown status or
HIV+ status, unless with HIV+ partner with known undetectable viral load).
- Not currently taking PrEP.
- NYC or Miami residential stability and planned availability for 12 months.
- Provision of informed consent.
Exclusion Criteria:
- Current suicidal or homicidal ideation.
- Evidence of active psychosis or gross cognitive impairment.
- Current enrollment in an intervention study.
- HIV-positive status.
We found this trial at
2
sites
New Haven, Connecticut 06520
Principal Investigator: John E Pachankis, PhD
Phone: 646-344-4060
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1120 Northwest 14th Street
Miami, Florida 33136
Miami, Florida 33136
Principal Investigator: Steve A Safren, PhD
Phone: 305-243-3508
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