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Intervention Development for Social Stress, Mental Health, and HIV Risk MSM (ESTEEM)

Primary Purpose

HIV Infections, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ESTEEM
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections

Eligibility Criteria

18 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subjective stress related to sexual identity over the previous three months;
  2. Symptoms of depression or anxiety within the past three months;
  3. HIV sexual risk behavior (one or more acts of condomless insertive or receptive anal sex with a male partner of unknown or discordant serostatus) within the past three months;
  4. Biological male gender;
  5. At least 18 years of age;
  6. Not known to have HIV;
  7. Residential stability and availability for six months;
  8. Ability to communicate in English; and
  9. Provision of informed consent.

Exclusion Criteria:

  1. active, unmedicated symptoms of bipolar I or bipolar II disorder or any Diagnostic and Statistical Manual-IV psychotic disorder in the past 12 months;
  2. Current suicidal or homicidal ideation;
  3. Evidence of gross cognitive impairment;
  4. Current enrollment in an HIV-related intervention or research study; and
  5. Knowledge of being infected with HIV.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    ESTEEM

    Waitlist

    Arm Description

    cognitive behavioral treatment adapted to improve depression, anxiety, and co-occurring health risks (i.e., alcohol use, sexual compulsivity, condomless sex) among young adult gay and bisexual men by reducing minority stress processes that underlie sexual orientation-related mental health disparities

    3-month waitlist control

    Outcomes

    Primary Outcome Measures

    reductions in the number of condomless anal sex acts in the past 90 days with HIV-positive or HIV-status-unknown male partners

    Secondary Outcome Measures

    reduction in depression severity as measured with the Center for Epidemiological Studies Depression Scale
    reduction in anxiety severity as measured with the Overall Anxiety Severity & Impairment Scale
    reduction in minority stressors as measured with the Sexual Orientation Concealment Scale
    reductions in psychological risk factors measured with the Ruminative Responses Scale
    reductions in number of days in which heavy alcohol and potentially harmful recreational substances were use
    among individuals with body image disturbance, improvements in body attitudes as measured with the Male Body Attitude Scale
    among individuals with sexual compulsivity, reduction in sexual compulsivity severity as measured with the Sexual Compulsivity Scale
    reduction in alcohol use problems as assessed with the Alcohol Use Disorders Identification Test
    in participants with generalized anxiety disorder, reduction in Penn State Worry Questionnaire
    reduction in depression severity as measured with the Overall Depression Severity & Impairment Scale
    reduction in anxiety severity as measured with the State Trait Anxiety Inventory (State subscale)
    reduction in minority stressors as measured with the Internalized Homophobia Scale
    reduction in minority stressors as measured with the Rejection Sensitivity Scale
    reductions in psychological risk factors measured with the Rathus Assertiveness Schedule
    reductions in psychological risk factors measured with the Difficulties of Emotion Regulation Scale
    reductions in psychological risk factors measured with the Multidimensional Scale of Perceived Social Support
    in participants with obsessive-compulsive disorder, reductions in the Yale-Brown OC Scale
    in participants with panic disorder, reduction in the Panic Disorder Severity Scale

    Full Information

    First Posted
    April 15, 2015
    Last Updated
    May 14, 2015
    Sponsor
    Yale University
    Collaborators
    Hunter College of City University of New York
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02448186
    Brief Title
    Intervention Development for Social Stress, Mental Health, and HIV Risk MSM
    Acronym
    ESTEEM
    Official Title
    Intervention Development for Social Stress, Mental Health, and HIV Risk Among MSM
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2012 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yale University
    Collaborators
    Hunter College of City University of New York

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The proposed study will adapt a cognitive behavioral intervention to support high-risk MSM's adaptive coping with minority stress, alleviate associated depression and anxiety, and reduce HIV risk behavior. The adapted intervention is expected to increase awareness of the unhealthy impact of minority stress; facilitate objective self-schemas in the face of minority stress; and strengthen one's skills and self-efficacy for managing minority stress and associated anxiety and depression to reduce risk for acquiring HIV.
    Detailed Description
    Gay, bisexual, and other men who have sex with men (MSM) are the population most severely affected by HIV in the U.S. and one of the only risk groups in the U.S. for which new infections continue to rise. MSM also experience a vastly disproportionate risk of mental health disorders, especially depression and anxiety. Numerous studies have shown that this mental health disparity arises from the early and ongoing stressors, known as minority stress, that MSM experience related to their sexual orientation. Despite the fact that minority stress is strongly related to anxiety and depression, and that minority stress and related mental health problems synergistically propel HIV risk behaviors, no existing HIV prevention intervention targets minority stress in order to reduce MSM's HIV risk behavior. This project aims to develop a theoretically-driven intervention that reduces the health-depleting effects of minority stress through targeting the basic psychosocial mechanisms linking minority stress to HIV risk behavior. These mechanisms include maladaptive emotion regulation, negative thinking styles, low self-efficacy, avoidance, and impulsivity, which are the very targets of an existing cognitive-behavioral, manualized intervention--the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UPTTED). The UPTTED changes these mechanisms using motivational interviewing, interoceptive and situational exposure, cognitive restructuring, mindfulness, and self-monitoring exercises, all grounded in cognitive-behavioral principles and developmental and affective neuroscience models of stress. The proposed study will adapt the UPTTED to support high-risk MSM's adaptive coping with minority stress, alleviate associated depression and anxiety, and reduce HIV risk behavior. The adapted UPTTED is expected to increase awareness of the unhealthy impact of minority stress; facilitate objective self-schemas in the face of minority stress; and strengthen one's skills and self-efficacy for managing minority stress and associated anxiety and depression to reduce risk for acquiring HIV. MSM who have experienced minority stress, mental health problems, and HIV risk behavior in the previous 3 months (n = 30) and community health experts (n = 30) will provide suggestions for adaptations to the existing intervention manual, including culturally relevant vignettes, examples, and exercises for adaptively responding to minority stress and managing HIV risk. The feasibility, acceptability, and preliminary efficacy of the adapted intervention will then be tested in a randomized waitlist controlled trial with MSM (n = 60) who report recent experiences with minority stress, depression and anxiety, and HIV risk behavior. The primary outcome will be HIV risk behavior. Secondary outcomes will be reductions in mediators including depression, anxiety, and the mechanisms of the conceptual model. This project innovatively seeks to test the preliminary efficacy of the first theoretically-driven intervention targeting the mental and sexual health consequences of minority stress and does so by targeting the underlying mechanisms that powerfully drive these simultaneous health threats.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections, Depression, Anxiety

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ESTEEM
    Arm Type
    Experimental
    Arm Description
    cognitive behavioral treatment adapted to improve depression, anxiety, and co-occurring health risks (i.e., alcohol use, sexual compulsivity, condomless sex) among young adult gay and bisexual men by reducing minority stress processes that underlie sexual orientation-related mental health disparities
    Arm Title
    Waitlist
    Arm Type
    No Intervention
    Arm Description
    3-month waitlist control
    Intervention Type
    Behavioral
    Intervention Name(s)
    ESTEEM
    Intervention Description
    10-session cognitive behavioral treatment
    Primary Outcome Measure Information:
    Title
    reductions in the number of condomless anal sex acts in the past 90 days with HIV-positive or HIV-status-unknown male partners
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    reduction in depression severity as measured with the Center for Epidemiological Studies Depression Scale
    Time Frame
    3 months
    Title
    reduction in anxiety severity as measured with the Overall Anxiety Severity & Impairment Scale
    Time Frame
    3 months
    Title
    reduction in minority stressors as measured with the Sexual Orientation Concealment Scale
    Time Frame
    3 months
    Title
    reductions in psychological risk factors measured with the Ruminative Responses Scale
    Time Frame
    3 months
    Title
    reductions in number of days in which heavy alcohol and potentially harmful recreational substances were use
    Time Frame
    3 months
    Title
    among individuals with body image disturbance, improvements in body attitudes as measured with the Male Body Attitude Scale
    Time Frame
    3 months
    Title
    among individuals with sexual compulsivity, reduction in sexual compulsivity severity as measured with the Sexual Compulsivity Scale
    Time Frame
    3 months
    Title
    reduction in alcohol use problems as assessed with the Alcohol Use Disorders Identification Test
    Time Frame
    3 months
    Title
    in participants with generalized anxiety disorder, reduction in Penn State Worry Questionnaire
    Time Frame
    3 months
    Title
    reduction in depression severity as measured with the Overall Depression Severity & Impairment Scale
    Time Frame
    3 months
    Title
    reduction in anxiety severity as measured with the State Trait Anxiety Inventory (State subscale)
    Time Frame
    3 months
    Title
    reduction in minority stressors as measured with the Internalized Homophobia Scale
    Time Frame
    3 months
    Title
    reduction in minority stressors as measured with the Rejection Sensitivity Scale
    Time Frame
    3 months
    Title
    reductions in psychological risk factors measured with the Rathus Assertiveness Schedule
    Time Frame
    3 months
    Title
    reductions in psychological risk factors measured with the Difficulties of Emotion Regulation Scale
    Time Frame
    3 months
    Title
    reductions in psychological risk factors measured with the Multidimensional Scale of Perceived Social Support
    Time Frame
    3 months
    Title
    in participants with obsessive-compulsive disorder, reductions in the Yale-Brown OC Scale
    Time Frame
    3 months
    Title
    in participants with panic disorder, reduction in the Panic Disorder Severity Scale
    Time Frame
    3 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subjective stress related to sexual identity over the previous three months; Symptoms of depression or anxiety within the past three months; HIV sexual risk behavior (one or more acts of condomless insertive or receptive anal sex with a male partner of unknown or discordant serostatus) within the past three months; Biological male gender; At least 18 years of age; Not known to have HIV; Residential stability and availability for six months; Ability to communicate in English; and Provision of informed consent. Exclusion Criteria: active, unmedicated symptoms of bipolar I or bipolar II disorder or any Diagnostic and Statistical Manual-IV psychotic disorder in the past 12 months; Current suicidal or homicidal ideation; Evidence of gross cognitive impairment; Current enrollment in an HIV-related intervention or research study; and Knowledge of being infected with HIV.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25554721
    Citation
    Pachankis JE. Uncovering Clinical Principles and Techniques to Address Minority Stress, Mental Health, and Related Health Risks Among Gay and Bisexual Men. Clin Psychol (New York). 2014 Dec;21(4):313-330. doi: 10.1111/cpsp.12078.
    Results Reference
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    Intervention Development for Social Stress, Mental Health, and HIV Risk MSM

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