Viewing Study NCT05509166


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Study NCT ID: NCT05509166
Status: RECRUITING
Last Update Posted: 2025-07-28
First Post: 2022-08-17
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Affirmative Psychotherapy for Sexual Minority Women's Mental and Behavioral Health
Sponsor: Yale University
Organization:

Study Overview

Official Title: A Unified Protocol to Address Sexual Minority Women's Minority Stress, Mental Health and Hazardous Drinking
Status: RECRUITING
Status Verified Date: 2025-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EQuIP
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.
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, New Jersey and Pennsylvania. 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 Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
1R01AA029088-01A1 NIH None https://reporter.nih.gov/quic… View