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临床试验/NCT05070793
NCT05070793暂停不适用

Improving Alcohol Use Disorder Treatment for Gender Minority Populations

New York State Psychiatric Institute2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
30
试验地点
2
主要终点
Feasibility - Completing all study sessions

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Culturally adapted interpersonal psychotherapy

Other

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

干预措施: Culturally adapted interpersonal psychotherapy (Behavioral)

结局指标

主要结局

Feasibility - Completing all study sessions

时间窗: 9 weeks

Percentage of participants who complete all intervention sessions

Acceptability - Treatment Acceptability Questionnaire

时间窗: 9 weeks

Treatment Acceptability Questionnaire

次要结局

  • Heavy drinking days(9 weeks and 13 weeks)

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Jeremy D. Kidd, MD, MPH

Clinical Psychiatrist

New York State Psychiatric Institute

研究点 (2)

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