Improving Alcohol Use Disorder Treatment for Gender Minority Populations

Alcohol Use Disorder Clinical Trial

Official title:

Improving Alcohol Use Disorder Treatment for Gender Minority Populations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05070793
• Other study ID #: 7953
• Secondary ID: 1K23AA028296
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 2025

Study information

• Verified date: January 2024
• Source: New York State Psychiatric Institute
• Contact: Jeremy D Kidd, MD
• Phone: 6467745563
• Email: Jeremy.Kidd[@]nyspi.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Separate evidence-based approaches exist for interpersonal distress (e.g., IPT) and alcohol (e.g., motivation interviewing; MI), but there are no integrated treatments for both that target the interpersonal contexts TGNB people face. IPT, a time-limited manualized psychotherapy, identifies an interpersonal problem area (grief, role disputes, role transitions, interpersonal deficits) and reduces symptoms by enhancing interpersonal coping and social support. IPT's focus on "role transition" and "role disputes" especially applies to gender transition-related interpersonal disruptions and distress. Over 133 clinical trials have validated IPT for depression and for PTSD-common co-morbidities for TGNB individuals. IPT AUD research is limited. Extant research on co-morbid depression and AUD is equivocal, but these studies were designed with depression as the primary outcome and enrolled mostly non-TGNB patients with low-level drinking. Researchers have called for studies of IPT with MI strategies for AUD in populations with salient interpersonal risk factors (i.e., TGNB populations).

STUDY PROCEDURES

Overall strategy: This pilot trial of culturally-adapted Brief Interpersonal Psychotherapy (IPT-B) for transgender and nonbinary (TGNB) individuals with AUD utilizes a single-arm, pre-post, convergent mixed methods design to explore whether and how the intervention engages interpersonal targets. This design enables the investigators to link qualitative themes regarding individuals' experiences of the intervention with quantitative measures of interpersonal targets. The investigators will also evaluate the feasibility of research and intervention procedures and the acceptability of the information and support provided by the therapist.

Participants: TGNB individuals with alcohol use disorder (AUD) (N = 20). We anticipate enrolling 50% individuals assigned female at birth and at least 30% non-White individuals.

Screening: Interested individuals will be complete a standardized telephone interview and will be invited to participate if they meet eligibility criteria for an evaluation. This subsequent evaluation will include the MINI International Neuropsychiatric Interview(57) to assess current and lifetime DSM-5 diagnoses, a psychiatric and medical evaluation (including urine drug screen). Eligible individuals will be invited to enroll in the trial and will provide written informed consent. Individuals will be compensated for this screening evaluation.

Assessment Schedule: After baseline assessment, there will be 9 weekly intervention visits plus 1-month follow-up. The intervention will be delivered by trained clinical staff. At intervention completion, participants will be provided with referrals for continued outpatient treatment and a list of Alcoholics Anonymous meetings. Study staff will administer outcomes measures without participating in intervention delivery. This will include administering alcohol and interpersonal target measures at Baseline, Weeks 5 and 9, and 1-month follow-up. At intervention completion (Week 9), study staff will administer acceptability measures; including qualitative assessment of treatment acceptability, interpersonal targets, and drinking. Participants will be compensated for completing study assessments. Psychotherapy will not be compensated. For safety, study staff will obtain vital signs and a breathalyzer before each visit; and will assess alcohol withdrawal and overall symptom severity at each visit. Staff will also assess for suicide risk and psychiatric symptoms at Baseline, Weeks 5 and 9, and 1-month follow-up.

Measures:

Feasibility: Staff will track data pertaining to recruitment, retention, and assessment procedures following CONSORT guidelines; including the duration and number of intervention contacts per participant.

Acceptability: After each session, therapists and participants will complete the Working Alliance Inventory-Short Form (WAI-SF) to assess their perception of the therapeutic alliance. Staff will use the Treatment Acceptability Questionnaire (TAQ) to assess participants' perceptions of the intervention's clarity/helpfulness/appropriateness/relevance and the therapist's skill and trustworthiness. This will include open-ended, qualitative questions about participants' experiences of the intervention (e.g., culturally-tailored elements); including perceived strengths and weaknesses, session length/content, therapeutic alliance, value of TGNB cultural adaptations, and recommendations for improvement.

Fidelity: Staff will audio record all intervention sessions. Sessions will be randomly chosen and reviewed by the Principal Investigator and an IPT research expert. Sessions will be scored using the Collaborative Study Psychotherapy Rating Scale-Form 6.

Demographics: Staff will collect information about age, race/ethnicity, assigned sex, education, and annual household income. Staff will also assess current/lifetime gender-affirming hormone use and surgeries.

Discrimination and Stigma: For descriptive purposes, staff will assess experiences of discrimination with the Everyday Discrimination Scale and stigma with the Stigma Consciousness Questionnaire.

Alcohol Consumption: The Timeline Followback (TLFB; 28-day at baseline; 7-day thereafter) to assess drinking and urine ethyl glucuronide (EtG), a metabolite of alcohol metabolism, as a biomarker of recent (~past 24-hour) drinking.

Alcohol Motivation/Expectancy: Readiness to Change Questionnaire-Treatment Version (RCQ-TV) to measure motivation to reduce drinking, Coping Strategies Scale (CSS) for coping ability with alcohol cravings, Alcohol Abstinence Self-Efficacy Scale (AASE) to measure participants' perceived ability to reduce drinking, Alcohol Expectancy Questionnaire (AEQ) to assess anticipated positive alcohol experiences, and Drinker Inventory of Consequences (DrInC) to measure negative alcohol consequences.

Interpersonal Targets: The Multidimensional Scale of Perceived Social Support (MSPSS) for family/friend support, an adapted scale from AFFIRM for GM peer support, the Social Adjustment Scale-Self Report (SAS-SR) to assess satisfaction with social supports, and the Inventory of Interpersonal Problems (IIP) to assess interpersonal disruptions/distress. Staff will use the Reflective Functioning Questionnaire (RFQ) to measure mentalization (ability to understand mental states of oneself and others). Increased mentalization capacity may be one mechanism by which IPT reduces interpersonal distress and psychiatric symptoms.

Co-morbidities: The Hamilton Depression Rating Scale (HAM-D) and PTSD Checklist (PCL-5) will assess these symptom domains. I will assess concurrent drug use with the Timeline Followback (28-day at baseline; 7-day thereafter) and urine qualitative drug screens.

Safety: Breathalyzer to assess alcohol intoxication, the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) to evaluate alcohol withdrawal, the Columbia Suicide Severity Rating Scale (CSSRS) for suicide risk, and the Clinical Global Impressions Scale for severity (CGI-S) and improvement (CGI-I).

Data analysis: This trial's purpose is to collect preliminary data about feasibility and engagement of interpersonal targets.

Missed Visits/Drop-Out: These rates are reported directly as part of the primary feasibility outcome.

Hypotheses: At least 75% of participants will complete the intervention (feasibility); At least 80% will report treatment satisfaction (acceptability).

Primary Analysis: Primary outcomes will be treatment feasibility (% completion) and acceptability (Treatment Acceptability Questionnaire). We will report quantitative data using descriptive statistics. For qualitative data, interviews will be audio recorded and professionally transcribed. Next, transcripts will be iteratively coded, identifying codes and categories (codebook) that we will apply to the entire data set. To ensure consistency, we will double-code 10% of interviews.

Exploratory outcomes: While this study does not have statistical power to test formal hypotheses regarding alcohol outcomes or interpersonal targets, we will examine % reduction in heavy drinking days (≥5 drinks for GM women; ≥4 for GM men) and % days abstinent as well as alcohol motivation/expectancy and interpersonal target variables. WE will measure pre-post change and report these using descriptive statistics.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Culturally adapted interpersonal psychotherapy
Individual psychotherapy based on Brief Interpersonal Psychotherapy, culturally adapted for transgender and nonbinary individuals.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

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* Note: There are 78 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - Completing all study sessions	Percentage of participants who complete all intervention sessions	9 weeks
Primary	Acceptability - Treatment Acceptability Questionnaire	Treatment Acceptability Questionnaire	9 weeks
Secondary	Heavy drinking days	Percent reduction in heavy drinking days (=5 drinks for GM women; =4 for GM men)	9 weeks and 13 weeks