Affirmative Psychotherapy for Sexual Minority Women's Mental and Behavioral Health (EQuIP)

January 10, 2024 updated by: Yale University

A Unified Protocol to Address Sexual Minority Women's Minority Stress, Mental Health and Hazardous Drinking

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 and New Jersey. 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 and New Jersey. 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.

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10001
        • Recruiting
        • Yale LGBTQ Mental Health Initiative with the Yale School of Public Office
        • Contact:
        • Principal Investigator:
          • John E Pachankis, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. be fluent in English
  2. self-identify as lesbian, bisexual, queer, pansexual, or other non-heterosexual identity
  3. report at least medium risk drinking level according to World Health Organization (WHO) (≥ 10 standard drinks/week, on average, in the past 30 days)
  4. report at least 1 heavy drinking day (≥4 drinks) at least once per week, on average, in the past 30 days
  5. 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 MINI)
  6. report at least minimum motivation to reduce drinking (measured by the Readiness Ruler)
  7. live in New York or New Jersey

Exclusion Criteria:

  1. report current mental health treatment ≥1 day/mo
  2. report having received any CBT in the past 12 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: LGBTQ-affirmative Cognitive Behavioral Therapy
10-session LGBTQ-affirmative psychotherapy using CBT techniques
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.
Behavioral: LGBTQ-affirmative Treatment-As-Usual
10-session LGBTQ-affirmative psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in heavy drinking
Time Frame: 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.
Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression Symptom Severity
Time Frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
The Center for Epidemiological Studies - Depression Scale (CES-D) will be used to compute an overall depression score (sum of the 20 items, with Items 3, 11, 14, and 16 reverse-scored). A higher score will indicate more depressive symptomatology during the past week. The range of scores for this outcome is 0-60.
Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Change in Emotion Regulation
Time Frame: Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up
Emotion regulation will be measured using a validated abbreviated version of the Difficulties in Emotion Regulation Scale. A sum score of 18 items will result in a range of scores from 18-90, with higher scores indicating more difficulty in emotion regulation.
Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: John E Pachankis, PhD, Yale University
  • Principal Investigator: Tonda Hughes, PhD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

August 17, 2022

First Submitted That Met QC Criteria

August 17, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2000033355
  • 1R01AA029088-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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