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Clinical Trials/NCT05070793
NCT05070793SuspendedNot Applicable

Improving Alcohol Use Disorder Treatment for Gender Minority Populations

New York State Psychiatric Institute2 sites in 1 country30 target enrollmentStarted: August 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Suspended
Enrollment
30
Locations
2
Primary Endpoint
Feasibility - Completing all study sessions

Study Overview

Brief Summary

Gender minority (GM; transgender and gender non-conforming) individuals experience disproportionately high rates of hazardous drinking and alcohol use disorder (AUD) and are an NIH-designated disparity population (NOT-MD-19-001). Despite marked disparities and unique alcohol risk factors, there are no evidence-based alcohol interventions for this population. This study will conduct mixed-methods formative research with an established multi-site longitudinal GM cohort to develop and assess the feasibility of the first culturally-adapted psychosocial treatment intervention for GMs with AUD. The study will evaluate an adapted version of interpersonal psychotherapy (IPT), with adaptations intended to enhance the responsiveness of IPT to the unique life experiences of GM individuals that may influence alcohol consumption.

Detailed Description

BACKGROUND

Transgender and nonbinary individuals (TGNB; i.e., gender minorities) have a gender identity and/or gender expression that differs from the female or male sex that they were assigned at birth. This difference (gender incongruence) can cause psychological distress. Comprising roughly 0.5% of the U.S. population, TGNB people bear numerous health disparities including hazardous drinking (HD; binge drinking and/or heavy drinking) and alcohol use disorder (AUD). These relate to stigma and discrimination. Numerous studies have found high rates of past 30-day drinking (21-58%), binge drinking (21-51%), and heavy drinking (26%). These rates exceed general population estimates of past 30-day binge drinking (16.3%) and heavy drinking (5.9%).

TGNB people suffer interpersonal disruptions that serve as culturally-distinct alcohol risk factors. Such interpersonal disruptions are related to HD via increased interpersonal distress. TGNB people have interpersonal distress in unique contexts such as gender transition and anti-TGNB discrimination/stigma. Gender transition is the process of reducing gender incongruence through aesthetics (e.g., clothing), hormones (e.g., estrogen/testosterone), and/or surgery (e.g., vaginoplasty/phalloplasty). This often brings changes in key interpersonal relationships, varying from renegotiation (e.g., a heterosexual couple adjusting to being a same-gender couple after one partner transitions) to dissolution (e.g., divorce). TGNB people also experience high rates of discrimination (distal minority stress) that affect relationships (e.g., a biased employer). In both contexts, interpersonal disruptions and distress increase alcohol risk, possibly via diminished social support. Many TGNB adults report drinking to cope with interpersonal stressors. Conversely, TGNB peer support protects against such distress and HD.

Culturally-adapted treatment may benefit interpersonal disruptions and distress occurring in the context of discrimination. Of TGNB adults, 24% reported having to teach their healthcare providers about TGNB experiences. Studies of addiction treatment staff found that most knew little about TGNB issues and nearly half held negative or ambivalent views about TGNB patients. Qualitative studies of TGNB individuals in addiction treatment found stigmatization was common, including prohibitions on disclosing TGNB identity or being forced to wear clothing inconsistent with gender identity. This can lead to treatment avoidance or termination.

Cultural-adaptation considers "language, culture, and context" to increase treatment compatibility with patients' cultural norms/values. Among various cultural adaptation models, the Cultural Sensitivity Framework (CSF) was specifically designed for addiction research. In CSF, adaptation addresses both surface (concrete) and deep (abstract) structures. In racial/ethnic and sexual minority (lesbian/gay/bisexual) studies, cultural adaptation improved treatment acceptability, retention, and effectiveness; including for addiction. Aside from conceptual discussions, there are no culturally-adapted TGNB AUD interventions.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •GM self-identification
  • •English fluency,
  • •Current DSM-5 Alcohol use disorder (AUD) (moderate-to-severe)
  • •AUD treatment-seeking
  • •Able to give informed consent and comply with study procedures

Exclusion Criteria

  • •Severe psychiatric symptoms that would interfere with treatment (e.g., psychosis, active suicidality)
  • •History of severe alcohol withdrawal (e.g., seizure, delirium tremens)
  • •Legally mandated to treatment
  • •Current DSM-5 SUD other than alcohol/nicotine/caffeine/cannabis

Arms & Interventions

Culturally adapted interpersonal psychotherapy

Other

Individual psychotherapy intervention based on Brief Interpersonal Psychotherapy (IPT-B) with additional cultural adaptation for transgender and nonbinary individuals.

Intervention: Culturally adapted interpersonal psychotherapy (Behavioral)

Outcomes

Primary Outcomes

Feasibility - Completing all study sessions

Time Frame: 9 weeks

Percentage of participants who complete all intervention sessions

Acceptability - Treatment Acceptability Questionnaire

Time Frame: 9 weeks

Treatment Acceptability Questionnaire

Secondary Outcomes

  • Heavy drinking days(9 weeks and 13 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor
Principal Investigator

Jeremy D. Kidd, MD, MPH

Clinical Psychiatrist

New York State Psychiatric Institute

Study Sites (2)

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