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

NCT05509166 | Recruiting DMC

• 2 other identifiers: 20000333551R01AA029088-01A1
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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

Keywords

LGBTQ; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• Change in heavy drinking

  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 Outcomes (14)

• Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)

  Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up

• Depression Symptom Severity

  Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up

• Anxiety Symptom Severity

  Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up

• Overall Depression Severity and Impairment Scale (ODSIS)

  Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up

• Overall Anxiety Severity and Impairment Scale (OASIS)

  Baseline, 4-month follow-up, 8-month follow-up, and 12-month follow-up

Study Arms (2)

LGBTQ-affirmative Cognitive Behavioral Therapy

EXPERIMENTAL

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

LGBTQ-affirmative Treatment-as-Usual

ACTIVE COMPARATOR

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

Interventions

LGBTQ-affirmative Cognitive Behavioral Therapy BEHAVIORAL

10-session LGBTQ-affirmative psychotherapy using CBT techniques

LGBTQ-affirmative Cognitive Behavioral Therapy

LGBTQ-affirmative Treatment-As-Usual BEHAVIORAL

10-session LGBTQ-affirmative psychotherapy

LGBTQ-affirmative Treatment-as-Usual

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender women, nonbinary women, transgender women and other gender diverse women are eligible to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be 18 years of age or older
• be fluent in English
• self-identify as lesbian, bisexual, queer, pansexual, or other non-heterosexual identity
• \) 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

You may not qualify if:

• report current mental health treatment ≥1 day/mo
• report having received any CBT in the past 3 months
• report current alcohol or drug abuse treatment, except mutual self-help (e.g., Alcoholics Anonymous)
• need alcohol detoxification indicated by ≥9 on Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar)
• exhibit active psychosis or active mania, as assessed by the Structured Clinical Interviews for DSM-5 Disorders (SCID) Psych Screen
• exhibit active suicidality or active homicidality, as assessed by the SCID-Psych Screen
• be currently legally mandated to attend treatment
• demonstrate gross cognitive impairment, as assessed with the Telephone Interview for Cognitive Status

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

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

New York, New York, 10001, United States

RECRUITING

Related Publications (11)

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  PMID: 27239096 BACKGROUND

• Sobell LC, Brown J, Leo GI, Sobell MB. The reliability of the Alcohol Timeline Followback when administered by telephone and by computer. Drug Alcohol Depend. 1996 Sep;42(1):49-54. doi: 10.1016/0376-8716(96)01263-x.

  PMID: 8889403 BACKGROUND

• Radloff LS. The CES-D scale: A self-report depression scale for research in the general population. Appl Psychol Meas. 1977;1(3):385-401.

  BACKGROUND

• Fong TG, Inouye SK. The Telephone Interview for Cognitive Status. Cogn Behav Neurol. 2018 Sep;31(3):156-157. doi: 10.1097/WNN.0000000000000165. No abstract available.

  PMID: 30239466 BACKGROUND

• Lang AJ, Norman SB, Means-Christensen A, Stein MB. Abbreviated brief symptom inventory for use as an anxiety and depression screening instrument in primary care. Depress Anxiety. 2009;26(6):537-43. doi: 10.1002/da.20471.

  PMID: 19016462 BACKGROUND

• Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.

  PMID: 9881538 BACKGROUND

• Shankman SA, Funkhouser CJ, Klein DN, Davila J, Lerner D, Hee D. Reliability and validity of severity dimensions of psychopathology assessed using the Structured Clinical Interview for DSM-5 (SCID). Int J Methods Psychiatr Res. 2018 Mar;27(1):e1590. doi: 10.1002/mpr.1590. Epub 2017 Oct 16.

  PMID: 29034525 BACKGROUND

• Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. doi: 10.1111/j.1360-0443.1989.tb00737.x.

  PMID: 2597811 BACKGROUND

• Maisto SA, Krenek M, Chung T, Martin CS, Clark D, Cornelius J. A comparison of the concurrent and predictive validity of three measures of readiness to change alcohol use in a clinical sample of adolescents. Psychol Assess. 2011 Dec;23(4):983-94. doi: 10.1037/a0024136. Epub 2011 Jul 18.

  PMID: 21767028 BACKGROUND

• Witkiewitz K, Hallgren KA, Kranzler HR, Mann KF, Hasin DS, Falk DE, Litten RZ, O'Malley SS, Anton RF. Clinical Validation of Reduced Alcohol Consumption After Treatment for Alcohol Dependence Using the World Health Organization Risk Drinking Levels. Alcohol Clin Exp Res. 2017 Jan;41(1):179-186. doi: 10.1111/acer.13272. Epub 2016 Dec 26.

  PMID: 28019652 BACKGROUND

• Pachankis J, Chiaramonte D, Scheer JR, Ankrum H, Eisenstadt B, Hobbs R, Baldwin H, Kidd JD, Witkiewitz K, Esserman DA, Plourde K, Drabble L, Hughes T. Randomised controlled trial of LGBTQ-affirmative cognitive-behavioural therapy for sexual minority women's minority stress, mental health and hazardous drinking: Project EQuIP protocol. BMJ Open. 2025 Mar 3;15(3):e086738. doi: 10.1136/bmjopen-2024-086738.

  PMID: 40032395 DERIVED

Study Officials

• John E Pachankis, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

• Tonda Hughes, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John E Pachankis, PhD

CONTACT

646-429-9407; John.Pachankis@yale.edu

Danielle M Chiaramonte, PhD

CONTACT

708-334-8331; Danielle.Chiaramonte@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be immediately assigned to either condition. Outcome assessors will be masked to study condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 22, 2022
• Study Start: February 1, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available 12 months after study completion for three years.
• Access Criteria: Data access requests from qualified academic investigators for non-commercial research interests will be reviewed by study investigators. Requestors will be required to sign a data access agreement.

Locations

US (1)