Recruiting

Affirmative Psychotherapy

Sponsor:

Yale University

Code:

NCT05509166

Conditions

Heavy Drinking

Mental Health Issue

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

LGBTQ-affirmative Cognitive Behavioral Therapy

LGBTQ-affirmative Treatment-As-Usual

Study Details

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.

Conditions

Heavy Drinking

Mental Health Issue

Study ID

NCT05509166

Start date

Feb 1, 2023

Status verified date

Jul, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

274 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

LGBTQ-affirmative Cognitive Behavioral Therapy

10-session LGBTQ-affirmative psychotherapy using CBT techniques

LGBTQ-affirmative Treatment-As-Usual

10-session LGBTQ-affirmative psychotherapy

Primary outcome measure

  • Change in heavy drinking [ Time Frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up ]

Central Contacts and Locations

Central contacts

Locations

Yale LGBTQ Mental Health Initiative with the Yale School of Public Office

Recruiting

New York, New York, United States, 10001

Contacts

Principal Investigator:

John E Pachankis, PhD

More Information

Sponsor

Yale University

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • LGBTQ
  • Cognitive Behavioral Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-07-09.