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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

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 groups in NCT02448186
Study groupRoleWhat they receive
ESTEEMExperimentalcognitive 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
WaitlistNo intervention3-month waitlist control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. reduction in depression severity as measured with the Center for Epidemiological Studies Depression Scale

    Measured: 3 months

  2. reduction in anxiety severity as measured with the Overall Anxiety Severity & Impairment Scale

    Measured: 3 months

  3. reduction in minority stressors as measured with the Sexual Orientation Concealment Scale

    Measured: 3 months

  4. reductions in psychological risk factors measured with the Ruminative Responses Scale

    Measured: 3 months

  5. reductions in number of days in which heavy alcohol and potentially harmful recreational substances were use

    Measured: 3 months

  6. among individuals with body image disturbance, improvements in body attitudes as measured with the Male Body Attitude Scale

    Measured: 3 months

  7. among individuals with sexual compulsivity, reduction in sexual compulsivity severity as measured with the Sexual Compulsivity Scale

    Measured: 3 months

  8. reduction in alcohol use problems as assessed with the Alcohol Use Disorders Identification Test

    Measured: 3 months

  9. in participants with generalized anxiety disorder, reduction in Penn State Worry Questionnaire

    Measured: 3 months

  10. reduction in depression severity as measured with the Overall Depression Severity & Impairment Scale

    Measured: 3 months

  11. reduction in anxiety severity as measured with the State Trait Anxiety Inventory (State subscale)

    Measured: 3 months

  12. reduction in minority stressors as measured with the Internalized Homophobia Scale

    Measured: 3 months

  13. reduction in minority stressors as measured with the Rejection Sensitivity Scale

    Measured: 3 months

  14. reductions in psychological risk factors measured with the Rathus Assertiveness Schedule

    Measured: 3 months

  15. reductions in psychological risk factors measured with the Difficulties of Emotion Regulation Scale

    Measured: 3 months

  16. reductions in psychological risk factors measured with the Multidimensional Scale of Perceived Social Support

    Measured: 3 months

  17. in participants with obsessive-compulsive disorder, reductions in the Yale-Brown OC Scale

    Measured: 3 months

  18. 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.

  1. First posted19 May 2015 (estimated)
  2. Study startJul 2012
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

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)
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

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.

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