HIV InfectionsESTEEMNCT02448186
Intervention Development for Social Stress, Mental Health, and HIV Risk MSM
A study testing ESTEEM in people with HIV Infections and Depression, run by Yale University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Depression, Anxiety
- What is being tested?
- ESTEEM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Show all 9Show fewer
- Residential stability and availability for six months;
- Ability to communicate in English; and
- Provision of informed consent.
Who cannot join
- 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.
About this study
Official title: Intervention Development for Social Stress, Mental Health, and HIV Risk Among MSM
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.
Read the 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.
- Conditions
- HIV Infections, Depression, Anxiety
- Being tested
- ESTEEM
- Medical subject headings
- HIV Infections, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESTEEMBehavioural
10-session cognitive behavioral treatment
| Study group | Role | What they receive |
|---|---|---|
| ESTEEM | Experimental | 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 Receives: Behavioral: ESTEEM |
| Waitlist | No intervention | 3-month waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
reductions in the number of condomless anal sex acts in the past 90 days with HIV-positive or HIV-status-unknown male partners
Measured: 3 months
Secondary outcomes (18)
reduction in depression severity as measured with the Center for Epidemiological Studies Depression Scale
Measured: 3 months
reduction in anxiety severity as measured with the Overall Anxiety Severity & Impairment Scale
Measured: 3 months
reduction in minority stressors as measured with the Sexual Orientation Concealment Scale
Measured: 3 months
reductions in psychological risk factors measured with the Ruminative Responses Scale
Measured: 3 months
reductions in number of days in which heavy alcohol and potentially harmful recreational substances were use
Measured: 3 months
among individuals with body image disturbance, improvements in body attitudes as measured with the Male Body Attitude Scale
Measured: 3 months
among individuals with sexual compulsivity, reduction in sexual compulsivity severity as measured with the Sexual Compulsivity Scale
Measured: 3 months
reduction in alcohol use problems as assessed with the Alcohol Use Disorders Identification Test
Measured: 3 months
in participants with generalized anxiety disorder, reduction in Penn State Worry Questionnaire
Measured: 3 months
reduction in depression severity as measured with the Overall Depression Severity & Impairment Scale
Measured: 3 months
reduction in anxiety severity as measured with the State Trait Anxiety Inventory (State subscale)
Measured: 3 months
reduction in minority stressors as measured with the Internalized Homophobia Scale
Measured: 3 months
reduction in minority stressors as measured with the Rejection Sensitivity Scale
Measured: 3 months
reductions in psychological risk factors measured with the Rathus Assertiveness Schedule
Measured: 3 months
reductions in psychological risk factors measured with the Difficulties of Emotion Regulation Scale
Measured: 3 months
reductions in psychological risk factors measured with the Multidimensional Scale of Perceived Social Support
Measured: 3 months
in participants with obsessive-compulsive disorder, reductions in the Yale-Brown OC Scale
Measured: 3 months
in participants with panic disorder, reduction in the Panic Disorder Severity Scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Hunter College of City University of New York
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448186
- Sponsor's protocol ID
- 1306012230
- Acronym
- ESTEEM
- Status last verified
- May 2015
- First submitted
- 15 Apr 2015
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25554721
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Development for Social Stress, Mental Health, and HIV Risk Among MSM
- ClinicalTrials.gov ID
- NCT02448186
- Acronym / sponsor ID
- ESTEEM / 1306012230
- Conditions
- HIV Infections, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Hunter College of City University of New York
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESTEEM | Experimental | Behavioral: ESTEEMcognitive 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 |
| Waitlist | No intervention | –3-month waitlist control |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESTEEM10-session cognitive behavioral treatment | Behavioural | ESTEEM |
Primary outcome
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
18 secondary outcomes
reduction in depression severity as measured with the Center for Epidemiological Studies Depression Scale
Time frame: 3 months
reduction in anxiety severity as measured with the Overall Anxiety Severity & Impairment Scale
Time frame: 3 months
reduction in minority stressors as measured with the Sexual Orientation Concealment Scale
Time frame: 3 months
reductions in psychological risk factors measured with the Ruminative Responses Scale
Time frame: 3 months
reductions in number of days in which heavy alcohol and potentially harmful recreational substances were use
Time frame: 3 months
among individuals with body image disturbance, improvements in body attitudes as measured with the Male Body Attitude Scale
Time frame: 3 months
among individuals with sexual compulsivity, reduction in sexual compulsivity severity as measured with the Sexual Compulsivity Scale
Time frame: 3 months
reduction in alcohol use problems as assessed with the Alcohol Use Disorders Identification Test
Time frame: 3 months
in participants with generalized anxiety disorder, reduction in Penn State Worry Questionnaire
Time frame: 3 months
reduction in depression severity as measured with the Overall Depression Severity & Impairment Scale
Time frame: 3 months
reduction in anxiety severity as measured with the State Trait Anxiety Inventory (State subscale)
Time frame: 3 months
reduction in minority stressors as measured with the Internalized Homophobia Scale
Time frame: 3 months
reduction in minority stressors as measured with the Rejection Sensitivity Scale
Time frame: 3 months
reductions in psychological risk factors measured with the Rathus Assertiveness Schedule
Time frame: 3 months
reductions in psychological risk factors measured with the Difficulties of Emotion Regulation Scale
Time frame: 3 months
reductions in psychological risk factors measured with the Multidimensional Scale of Perceived Social Support
Time frame: 3 months
in participants with obsessive-compulsive disorder, reductions in the Yale-Brown OC Scale
Time frame: 3 months
in participants with panic disorder, reduction in the Panic Disorder Severity Scale
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
- Background: PubMed 25554721Pachankis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ESTEEM in people with HIV Infections and Depression, run by Yale University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02448186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2015.