Clinical trial NCT03721276: Project EQuIP: Empowering Queer Identities in Psychotherapy
Official title: Project EQuIP: Empowering Queer Identities in Psychotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Minority Stress
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to develop an evidence-based psychosocial intervention for sexual minority women. This intervention will specifically target the adverse mental and behavioral health outcomes disproportionately experienced by sexual minority women, including depression, suicidality, and alcohol abuse, which are known to be driven by stigma-related stressors associated with their sexual orientation (i.e., minority stress processes).

Detailed description: The purpose of this study is to adapt ESTEEM (Effective Skills to Empower Effective Men), developed by Dr. John Pachankis, to simultaneously target the multiple adverse health outcomes sexual minority women disproportionately face, including depression, suicidality, and alcohol abuse, that are linked to minority stress processes.

Project EQuIP will adapt the ESTEEM program for sexual minority women in three distinct phases. The focus of this registered protocol will be Phase 3, however Phases 1, 2 and 3 are described below.

Phase 1 will involve conducting interviews with 20 sexual minority women (SMW) who report experiencing depression, suicidality, and alcohol abuse. Information from these interviews will be used to gather insight from participants that can help inform the adaptation of a cognitive-behavioral treatment approach to specifically target sexual minority women's unique experiences with minority stress.

Phase 2 will involve consultation interviews with 10 community-based mental health experts who treat psychosocial health problems among at-risk SMW. Involvement of key community members in intervention design optimizes intervention dissemination and allows frontline professionals to shape the intervention that they would be most willing to implement. Input of mental health experts working with the SMW community will be used in order to translate existing, but largely untapped, clinical wisdom regarding SMW's minority stress experiences, mental health, and alcohol use into the development of the intervention.

Phase 3 will involve pilot testing the adapted cognitive-behavioral treatment through a randomized controlled trial with 60 SMW who report experiencing depression, anxiety, and alcohol abuse.

Eligibility criteria: For Phase 3

Inclusion Criteria:

* sexual minority status operationalized as identity (e.g., lesbian, bisexual, pansexual, queer)
* aged 18-35
* self-identification as a woman with the option of selecting multiple gender identities
* symptoms of anxiety or depression within the past 90 days (≥ 2.5 on the BSI-4 for either anxiety or depression)
* at least one instance of past-90-day heavy drinking (i.e., ≥ 4 drinks in one sitting)
* 6-month NYC residential stability and availability
* English fluency

Exclusion Criteria:

* active psychosis or active mania
* active suicidality or active homicidality
* currently in mental health treatment exceeding one day per month
* having received any cognitive-behavioral therapy treatment in the past 12 months
* evidence of gross cognitive impairment

Primary outcomes:
measure: Depression
timeFrame: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)
measure: Brief Symptom Inventory
timeFrame: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)
measure: Alcohol Use
timeFrame: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)
Secondary outcomes:
measure: Overall Depression Severity and Impairment Scale
timeFrame: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)
measure: Overall Anxiety Severity and Impairment Scale
timeFrame: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)
measure: Suicidal Ideation Attributes Scale
timeFrame: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)
measure: Lesbian, Gay, and Bisexual Identity Scale-Internalized Homonegativity Subscale
timeFrame: Three-month pre-intervention, Immediate Pre-intervention, Post-intervention, Three-month Follow-up (Post Intervention)
Other outcomes:
Locations:
city: New York
country: United States
facility: Yale LGBTQ+ Mental Health Initiative - Research Lab
state: New York
Study officials:
affiliation: Associate Professor of Public Health (Social and Behavioral Sciences)
name: John Pachankis, PhD
role: PRINCIPAL_INVESTIGATOR
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