NCT02448186

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Jul 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

2.4 years

First QC Date

April 15, 2015

Last Update Submit

May 14, 2015

Conditions

HIV InfectionsDepressionAnxiety

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (18)

  • reduction in depression severity as measured with the Center for Epidemiological Studies Depression Scale

    3 months

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

    3 months

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

    3 months

  • reductions in psychological risk factors measured with the Ruminative Responses Scale

    3 months

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

    3 months

  • +13 more secondary outcomes

Study Arms (2)

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

Behavioral: ESTEEM

Waitlist

NO INTERVENTION

3-month waitlist control

Interventions

ESTEEMBEHAVIORAL

10-session cognitive behavioral treatment

ESTEEM

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25554721BACKGROUND

MeSH Terms

Conditions

HIV InfectionsDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2015

First Posted

May 19, 2015

Study Start

July 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 19, 2015

Record last verified: 2015-05