A Unified Protocol to Address Sexual Minority Women's Minority Stress, Mental Health and Hazardous Drinking
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Change in heavy drinking
研究概览
简要总结
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, New Jersey and Pennsylvania. 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.
详细描述
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, New Jersey and Pennsylvania. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be immediately assigned to either condition. Outcome assessors will be masked to study condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be 18 years of age or older
- •be fluent in English
- •self-identify as lesbian, bisexual, queer, pansexual, or other non-heterosexual identity
- •3) report at ≥ 8 standard drinks/week, on average, in the past 30 days, OR report at least 2 heavy drinking days ( ≥ 4 drinks in one day) in the past 30 days 4) 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 DIAMOND) 5) report at least minimum motivation to reduce drinking (measured by the Readiness Ruler) 6) live in New York, New Jersey, and Pennsylvania and planning to stay for at least the next 4 months
排除标准
- •report current mental health treatment ≥1 day/mo
- •report having received any CBT in the past 3 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
研究组 & 干预措施
LGBTQ-affirmative Cognitive Behavioral Therapy
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.
干预措施: LGBTQ-affirmative Cognitive Behavioral Therapy (Behavioral)
LGBTQ-affirmative Treatment-as-Usual
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.
干预措施: LGBTQ-affirmative Treatment-As-Usual (Behavioral)
结局指标
主要结局
Change in heavy drinking
时间窗: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
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.
次要结局
- Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)(Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up)
- Depression Symptom Severity(Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up)
- Anxiety Symptom Severity(Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up)
- Overall Depression Severity and Impairment Scale (ODSIS)(Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up)
- Overall Anxiety Severity and Impairment Scale (OASIS)(Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up)
- PTSD symptoms(Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up)
- Effects of Alcohol Use(Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up)
- Frequency of Alcohol Use(Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up)
- Suicidal Ideation(Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up)
- Mental Health Symptom Presence and Severity(Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up)
- Alcohol Use(Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up)
- Alcohol Self-Efficacy(Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up)
- Drug Use and Drug-Related Problems(Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up)
- Cannabis Use and Cannabis-Related Problems(Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up)