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New LGBTQ-Affirmative therapy aims to curb heavy drinking in queer women

NCT ID NCT05509166

Symptom relief Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This study tests a 10-session LGBTQ-affirmative cognitive behavioral therapy (CBT) delivered via telehealth to sexual minority women who drink heavily and have anxiety or depression. Researchers will compare it to standard LGBTQ-affirmative therapy to see if it better reduces heavy drinking days and mental health symptoms. The trial is recruiting 274 participants in New York, New Jersey, and Pennsylvania.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LGBTQ-affirmative Cognitive Behavioral Therapy (CBT)
What this could lead to
If it works, this could provide an effective, tailored therapy to reduce heavy drinking and improve mental health in sexual minority women.
What could go wrong
This is a relatively small, early-stage trial (274 participants) and the therapy may not outperform standard LGBTQ-affirmative care. Results may not apply to all groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 274 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

anxiety disorder depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heavy drinking Mental health issue

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    New York, New York, 10001, United States

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