R01AA028240

A Female-Specific Cognitive Behavioral Therapy Group for Alcohol Use Disorder in VA Primary Care Settings - Project Summary:

Women comprise 10% of the U.S. veteran population, expected to rise to 35% by 2035.1, 2 37% of female veterans report risky or problem alcohol use4, and many have complex comorbidity requiring specialized treatment5 but only 2% of women veterans receive treatment in VA Substance Use Disorder (SUD) clinics. There is currently no evidence-based, veteran-centric, female segregated treatment with female-specific programming for AUD or SUD at the VA.

The vast majority of women at the V.A. are limited to gender-neutral treatments for AUD in specialty SUD clinics, which is a mixed gender setting and is unappealing to women veterans6. Only 19%7 to 30%8 of VAs offer female-only SUD treatments, and these are offered in specialty SUD clinics and do not contain women-specific content shown to be crucial for efficacy9.

Since women are likely to seek AUD care with their primary care (PC) providers10, 11, and women veterans report preference for PC colocation of AUD services12, PC is a promising setting to reduce treatment entry barriers, increase access to care and outcome efficacy for AUD among women veterans.

This R01 resubmission, "A Female-Specific Cognitive Behavioral Therapy (CBT) Group for Alcohol Use Disorder in VA Primary Care Settings," in response to PA-19-055, and NOT-AA-19-010, proposes a hybrid type 118 study to adapt a single-gender group modality female-specific CBT developed for civilian females with AUD19-22, 41, and to test the new veteran-centric female-specific CBT group (FS-CBT) in VA PC at New York Harbor Healthcare System (NYHHS) VA, compared to usual care (UC) for AUD in PC.

FS-CBT is a unique 12-session weekly group CBT treatment for AUD, providing:
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.

Aim 1. RCT (N=162) testing FS-CBT+UC for AUD in PC compared to UC only in PC for women veterans, with baseline and 3-, 9-, 15-month assessments. UC will be delivered by grant-funded PCP staff to ensure fidelity.

H.1A. Women VA PC patients in FS-CBT+UC for AUD at a PC site will be more likely to access and engage in treatment for AUD than women in UC.
H.1B. Women in FS-CBT+UC will have better drinking and secondary outcomes than women in UC only.
H.1C. Outcomes in FS-CBT+UC vs UC will be mediated by social support, AUD medication, coping skills, and subjective distress.

Aim 2. Formative evaluation of FS-CBT with 20 women veterans in FS-CBT, 20 in UC, 15 who did not enroll, and 16 PC providers, using "Consolidated Framework for Implementation Research" will be done.

This project is consistent with NIAAA priorities for behavioral and health services, and advancing science for the health of women: Trans-NIH Strategic Plan24, and the VA Strategic Plan25 to focus resources more efficiently and improve timeliness of services. The long-term objective is to produce an "off the shelf" treatment to fill a gap in evidence-based, accessible, patient-centered AUD treatment for women veterans.

University Of Massachusetts Medical School

TO DEVELOP A SOUND FUNDAMENTAL KNOWLEDGE BASE WHICH CAN BE APPLIED TO THE DEVELOPMENT OF IMPROVED METHODS OF TREATMENT AND MORE EFFECTIVE STRATEGIES FOR PREVENTING ALCOHOLISM AND ALCOHOL-RELATED PROBLEMS. THE NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM (NIAAA) SUPPORTS RESEARCH IN A BROAD RANGE OF DISCIPLINES AND SUBJECT AREAS RELATED TO BIOMEDICAL AND GENETIC FACTORS, PSYCHOLOGICAL AND ENVIRONMENTAL FACTORS, ALCOHOL-RELATED PROBLEMS AND MEDICAL DISORDERS, HEALTH SERVICES RESEARCH, AND PREVENTION AND TREATMENT RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION AND TECHNOLOGY TRANSFER THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.273 - Alcohol Research Programs

National Institute on Alcohol Abuse and Alcoholism (NIAAA) [HHS - NIH]

Worcester, Massachusetts 01655 United States

Single Zip Code

Research Project Grant (Parent R01 Clinical Trial Required) (PA-19-055)

Amendment Since initial award the End Date has been extended from 01/31/26 to 01/31/27 and the total obligations have increased 435% from $612,812 to $3,280,364.