Telehealth therapy for sexual minority women's mental health and heavy drinking
A Unified Protocol to Address Sexual Minority Women's Minority Stress, Mental Health and Hazardous Drinking
This study is testing a new online therapy program for sexual minority women to see if it can help reduce heavy drinking and improve mental health compared to standard therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05509166 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a 10-session LGBTQ-affirmative cognitive behavioral therapy (CBT) delivered via telehealth for sexual minority women in New York, New Jersey, and Pennsylvania. The intervention, known as EQuIP (Empowering Queer Identities in Psychotherapy), aims to reduce heavy drinking and mental health symptoms such as depression by addressing the unique stressors faced by this population. Participants will be randomly assigned to receive either the EQuIP treatment or standard LGBTQ-affirmative treatment, with assessments of psychosocial mechanisms that may mediate treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are sexual minority women aged 18 and older who experience heavy drinking and mental health issues.
Not a fit: Patients currently receiving mental health treatment or who have had recent cognitive behavioral therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve mental health and reduce heavy drinking among sexual minority women.
How similar studies have performed: Other studies have shown promise in using affirmative therapy approaches for LGBTQ populations, suggesting potential success for this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. be 18 years of age or older 2. be fluent in English 3. 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 Exclusion Criteria: 1. report current mental health treatment ≥1 day/mo 2. report having received any CBT in the past 3 months 3. report current alcohol or drug abuse treatment, except mutual self-help (e.g., Alcoholics Anonymous) 4. need alcohol detoxification indicated by ≥9 on Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) 5. exhibit active psychosis or active mania, as assessed by the Structured Clinical Interviews for DSM-5 Disorders (SCID) Psych Screen 6. exhibit active suicidality or active homicidality, as assessed by the SCID-Psych Screen 7. be currently legally mandated to attend treatment 8. demonstrate gross cognitive impairment, as assessed with the Telephone Interview for Cognitive Status
Where this trial is running
New York, New York
- Yale LGBTQ Mental Health Initiative with the Yale School of Public Office — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: John E Pachankis, PhD — Yale University
- Study coordinator: John E Pachankis, PhD
- Email: John.Pachankis@yale.edu
- Phone: 646-429-9407
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.