NCT05509166 Affirmative Psychotherapy for Sexual Minority Women's Mental and Behavioral Health
| NCT ID | NCT05509166 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Heavy Drinking |
| Study Type | INTERVENTIONAL |
| Enrollment | 274 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 274 participants in total. It began in 2023-02-01 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
John E Pachankis, PhD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT05509166 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heavy Drinking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05509166 currently recruiting?
Yes, NCT05509166 is actively recruiting participants. Contact the research team at John.Pachankis@yale.edu for enrollment information.
Where is the NCT05509166 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05509166 clinical trial?
NCT05509166 is sponsored by Yale University. The principal investigator is John E Pachankis, PhD at Yale University. The trial plans to enroll 274 participants.