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

About this trial
This is an interventional prevention trial for HIV Infections
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.
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
NCT ID
NCT02448186
First Posted
April 15, 2015
Last Updated
May 14, 2015
Sponsor
Yale University
Collaborators
Hunter College of City University of New York
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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