A Female-Specific CBT Group for Veteran Women With Alcohol Use Disorder in VA Primary Care Settings

NCT06118346 | Recruiting

• 2 other identifiers: H000213041R01AA028240-01A1
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate a Female-Specific Cognitive Behavioral Therapy (CBT) Group as treatment for Alcohol Use Disorder among Veteran women.

Conditions

Alcohol Use Disorder; Risky Health Behavior

Outcome Measures

Primary Outcomes (5)

• Alcohol Use Disorders Identification Test (AUDIT)

  10-item screening tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems

  assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up

• Structured Clinical Interview for DSM Disorders (SCID) Alcohol Use Disorder Module

  semi-structured interview that assesses for alcohol use disorder based on the Diagnostic and Statistical Manual for Mental Disorders (DSM)

  assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up

• Form 90 Timeline Followback (TLFB)

  interview used to assess alcohol and drug use over a specific period of time

  assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up

• Treatment Services Review (TSR)

  interview used to assess use of Veterans Affairs and non-Veterans Affairs treatments including Alcohol Use Disorder treatment, physical and mental health treatment, and use of medications

  assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up

• Electronic Medical Record (EMR)

  patient's medical records - review to assess use of Veterans Affairs and non-Veterans Affairs treatments including Alcohol Use Disorder treatment, physical and mental health treatment, and use of medications

  assessed from baseline to 15-months post-baseline follow-up

Secondary Outcomes (8)

• Outcome Questionnaire-45

  assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up

• Posttraumatic Stress Disorder Checklist (PCL)-5 with Life Events Checklist (LEC)-5

  assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up

• Difficulties in Emotion Regulation Scale (DERS)

  assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up

• Coping Strategies Scale (CSS)

  assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up

• Important People Interview (IPI)

  assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up

Study Arms (2)

Female-Specific Cognitive Behavioral Therapy

EXPERIMENTAL

Participants in this arm will receive female-specific cognitive behavioral therapy and usual VA care for alcohol use disorder.

Behavioral: Female-Specific Cognitive Behavioral Therapy (FS-CBT); Behavioral: Usual Care

Usual Care

ACTIVE COMPARATOR

Participants in this arm will receive usual VA care for alcohol use disorder.

Behavioral: Usual Care

Interventions

Female-Specific Cognitive Behavioral Therapy (FS-CBT) BEHAVIORAL

FS-CBT is a unique 12-session weekly group CBT treatment designed for women Veterans with AUD and/or risky drinking, and provides (1) AUD interventions, (2) general female-specific content, (3) female-Veteran content, (4) wellness and self-care, and (5) a novel 24/7 social support for abstinence discussion mobile app.

Female-Specific Cognitive Behavioral Therapy

Usual Care BEHAVIORAL

Usual care means that participants will receive brief alcohol counseling and have access to available treatments for AUD at the VA.

Female-Specific Cognitive Behavioral Therapy; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: identifies as a woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women aged 18 or older
• Veteran of the U.S. Armed Forces
• Enrolled in healthcare at VA NYHHS;
• AUDIT-C ≥3 plus diagnosis of AUD and/or risky drinking (defined by the National Institute on Alcohol Abuse and Alcoholism as more than 3 drinks on any one day or more than 7 drinks per week) on more detailed screening
• consumed alcohol within 90 days prior to our study's initial eligibility screen.

You may not qualify if:

• participant is acutely suicidal
• participant has acute psychotic or manic symptoms associated with severe mental illness
• participant is pregnant at initial eligibility screen.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

VA New York Harbor Healthcare System

New York, New York, 10010, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Health Risk Behaviors

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Study Officials

• Elizabeth E Epstein, PHD

  University of Massachusetts Chan Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeleine P Stein, MPH

CONTACT

9294169161; madeleine.stein2@umassmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: November 7, 2023
• Study Start: February 24, 2023
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: February 24, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)