Affirmative Psychotherapy for Sexual Minority Women's Mental and Behavioral Health

Study Overview
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Brief Summary
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The purpose of this 2-arm randomized controlled trial is to assess the efficacy of a 10-session lesbian, gay, bisexual, transgender, and queer (LGBTQ)-affirmative cognitive-behavioral psychotherapy (CBT) delivered via telehealth in a large sample of sexual minority women (SMW) in New York and New Jersey. The investigators will assess whether the EQuIP(Empowering Queer Identities in Psychotherapy) treatment demonstrates significant reductions in heavy drinking (HD) and mental health symptoms (e.g., depression) compared to LGBTQ-affirmative treatment-as-usual.

Detailed Description
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The purpose of this study is to assess the efficacy of a 10-session LGBTQ-affirmative cognitive behavioral psychotherapy (CBT) delivered via telehealth in a large sample of sexual minority women (SMW) in New York and New Jersey. The treatment, EQuIP (Empowering Queer Identities in Psychotherapy), uses a CBT-based transdiagnostic approach to target the common cognitive, affective, and behavioral responses to minority stress that lead to mental and behavioral health disparities for sexual minority women. We will assess in a 2-arm randomized controlled trial (RCT) whether the EQuIP treatment demonstrates significant reductions in heavy drinking (HD) and mental health symptoms (e.g., depression) compared to LGBTQ-affirmative Treatment-As-Usual. The investigators will assess whether psychosocial mechanisms (e.g., emotion dysregulation) mediate reductions in heavy drinking and separately and identify whether EQuIP is differentially efficacious across key demographic factors.

Official Title
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A Unified Protocol to Address Sexual Minority Women's Minority Stress, Mental Health and Hazardous Drinking

Conditions
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Heavy Drinking, Mental Health Issue

Intervention / Treatment
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* Behavioral: LGBTQ-affirmative Cognitive Behavioral Therapy
* Behavioral: LGBTQ-affirmative Treatment-As-Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be fluent in English self-identify as lesbian, bisexual, queer, pansexual, or other non-heterosexual identity report at least medium risk drinking level according to World Health Organization (WHO) (≥ 10 standard drinks/week, on average, in the past 30 days) report at least 1 heavy drinking day (≥4 drinks) at least once per week, on average, in the past 30 days currently experience a Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 depression or anxiety disorder (screened initially using a cutoff of ≥ 2 on the Brief Symptom Inventory-4 and further confirmed by diagnostic interview via the MINI) report at least minimum motivation to reduce drinking (measured by the Readiness Ruler) live in New York or New Jersey Exclusion Criteria: report current mental health treatment ≥1 day/mo report having received any CBT in the past 12 months report current alcohol or drug abuse treatment, except mutual self-help (e.g., Alcoholics Anonymous) need alcohol detoxification indicated by ≥9 on Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) exhibit active psychosis or active mania, as assessed by the Structured Clinical Interviews for DSM-5 Disorders (SCID) Psych Screen exhibit active suicidality or active homicidality, as assessed by the SCID-Psych Screen be currently legally mandated to attend treatment demonstrate gross cognitive impairment, as assessed with the Telephone Interview for Cognitive Status

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LGBTQ-affirmative Cognitive Behavioral Therapy<br>Individuals assigned to LGBTQ-affirmative cognitive behavioral therapy will receive 10 weekly individually-delivered sessions, directly after baseline assessment, delivered via telehealth. Based on the Unified Protocol, sessions will address minority stress mechanisms underlying sexual minority women's depression, anxiety, and alcohol abuse. | Behavioral: LGBTQ-affirmative Cognitive Behavioral Therapy<br>* 10-session LGBTQ-affirmative psychotherapy using CBT techniques<br>|
| Active Comparator: LGBTQ-affirmative Treatment-as-Usual<br>Individuals assigned to LGBTQ-affirmative Treatment-as-Usual will receive 10 weekly sessions from a therapist at the Institute for Human Identity who will provide their LGBTQ-affirmative therapy services via telehealth. | Behavioral: LGBTQ-affirmative Treatment-As-Usual<br>* 10-session LGBTQ-affirmative psychotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heavy drinking | The proportion of heavy drinking days will be assessed using a 30-day Timeline Followback. The Timeline Followback is a structured interview that will assess alcohol use over the past 30 days. Heavy drinking days are defined as those in which more than four drinks were consumed within a two-hour period. | Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression Symptom Severity | The Center for Epidemiological Studies - Depression Scale (CES-D) will be used to compute an overall depression score (sum of the 20 items, with Items 3, 11, 14, and 16 reverse-scored). A higher score will indicate more depressive symptomatology during the past week. The range of scores for this outcome is 0-60. | Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up | 
| Change in Emotion Regulation | Emotion regulation will be measured using a validated abbreviated version of the Difficulties in Emotion Regulation Scale. A sum score of 18 items will result in a range of scores from 18-90, with higher scores indicating more difficulty in emotion regulation. | Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LGBTQ, Cognitive Behavioral Therapy