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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06118346
• Other study ID #: H00021304
• Secondary ID: 1R01AA028240-01A
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2023
• Est. completion date: January 30, 2026

Study information

• Verified date: December 2023
• Source: University of Massachusetts, Worcester
• Contact: Madeleine P Stein, MPH
• Phone: 9294169161
• Email: madeleine.stein2[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a five year Hybrid Type 1 effectiveness-implementation study. For Aim 1, 162 female Veterans with AUD will be enrolled over 2.5 years in the study at Primary Care and Women's Comprehensive Primary Care Clinics (i.e., the Women's Health Clinic) in the VA New York Harbor Healthcare System (VA NYHHS) (n=162) for a final sample of 140 at 15 month post-baseline (i.e.,12 month post treatment) follow up. The 86% follow up rate is based on Dr. Epstein's prior Randomized Control Trial (RCT) testing FS-CBT for civilian women with AUD on which the current Veteran- Centric FS-CBT group is based. After the research baseline interview, participants will be randomly assigned to either Usual Care (UC, which is Brief Alcohol Counseling +Referral to Substance Use Disorder (SUD) Specialty Care if indicated, all called Brief Alcohol Counselling (BAC), and otherwise also known as Brief Intervention and Referral to treatment (BIRT)) or to the 12 session, rolling entry group Veteran Female Specific CBT for AUD (FS-CBT) held within the VA NYHHS Women's Health Clinic. Participants in both conditions will complete the same baseline (BL), 3-, 9- and 15-months post-BL (i.e., 0-, 6-, & 12-months after treatment) research assessments. Primary outcome variables will be treatment access (attending least one FS- CBT group session or 1 SUD specialty care session in the FS-CBT condition, and at least 1 SUD specialty care session in the usual UC condition; treatment engagement is defined as number of treatment hours attended in each condition); drinking outcomes (percent drinking days and percent heavy drinking days during and 1 year after the treatment phase). Secondary outcomes include drug use, mental health, social support for abstinence, and health behaviors. For Aim 2, a formative evaluation will be done during the RCT using program process data to track provider interest, patient enrollment rates, reasons for refusal, and treatment adherence. Using an implementation science framework (Consolidated Framework for Implementation Research, CFIR), the investigators will evaluate implementation barriers and facilitators of FS-CBT in VA PC using qualitative interviews with 20 women Veterans in FS-CBT, 20 in UC, 15 women with AUD who were eligible but did not enroll in the RCT, and 16 providers/stakeholders. The goal of the formative evaluation is to help determine factors at the system, provider, and patient levels that affect the likelihood that FS-CBT will be successfully implemented and sustained in VA Primary Care (PC). The evaluation will allow for more rapid translational gains in terms of intervention uptake and sustainability. The evaluation will include the systematic collection of quantitative RCT process data (e.g., number and % of patient referral opt-outs by Primary Care Providers (PCPs), % of eligible women who enroll, reasons for refusal, number of group sessions completed by Veteran characteristics), and qualitative data via interviews with patient and staff stakeholders. To learn about patient-level barriers/facilitators, study personnel will conduct interviews with 20 female Veterans who were randomized to the FS-CBT condition, and 20 who were randomized to UC: (a) one-half will be drawn from those who completed the full dose (12 sessions in FS-CBT and all treatment recommendations in UC) and the other half from those who dropped out and completed less than the recommended minimal dose. Investigators will sample from participants who significantly reduced their drinking and from those who did not. Investigators will include a diverse sample of Veterans based on age, gender, race/ethnicity, era of military service, and diagnoses (e.g., PTSD). Lastly, study personnel will interview 15 women with AUD who were eligible but did not enroll in the RCT to understand their perceptions of the program and barriers to participation. The CFIR framework will be used to guide the interview approach. CFIR is a typology of 39 constructs from five main domains that identify factors associated with successful implementation and maintenance of health care innovations: (1) Intervention Characteristics; (2) Inner Setting; (3) Outer Setting; Characteristics of Individuals; (5) Process. If Aim 1 hypotheses are supported, these interviews will help guide subsequent implementation trials of FS-CBT by explaining: (a) barriers and facilitators to participation; perceptions about why FS-CBT is successful at achieving better outcomes for women Veterans with AUD; the barriers and facilitators to high fidelity implementation of FS-CBT; and the sustainability of FS-CBT in the absence of a funded research project and how to achieve this goal; and (b) how FS-CBT should be adjusted to appeal to the subgroup of Veterans. If Aim 1 hypotheses are not supported, the interviews will determine the reasons why (i.e., questions posed to staff and patients will solicit information on barriers associated with delivery of FS-CBT during the RCT, and what modifications to FS-CBT could be made to maximize effectiveness).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: January 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• 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.

Exclusion criteria:

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Risky Health Behavior

Intervention

Behavioral:
• Female-Specific Cognitive Behavioral Therapy (FS-CBT)
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.
• Usual Care
Usual care means that participants will receive brief alcohol counseling and have access to available treatments for AUD at the VA.

Locations

Country	Name	City	State
United States	VA New York Harbor Healthcare System	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Outcome Questionnaire-45	self-report questionnaire used to rate symptoms, interpersonal problems, and social role dysfunction	assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up
Secondary	Posttraumatic Stress Disorder Checklist (PCL)-5 with Life Events Checklist (LEC)-5	combined self-report questionnaire and interview used to measure posttraumatic stress disorder symptoms	assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up
Secondary	Difficulties in Emotion Regulation Scale (DERS)	self-report questionnaire that assesses emotion regulation	assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up
Secondary	Coping Strategies Scale (CSS)	self-report questionnaire used to assess use of coping strategies	assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up
Secondary	Important People Interview (IPI)	interview used to assess social network characteristics	assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up
Secondary	Sociotropy Autonomy Scale (SAS)	self-report questionnaire used to assess the two personality dimensions of sociotropy and autonomy	assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up
Secondary	Use of Women2Women mobile application	tracking use of mobile app designed to allow participants randomized to the FS-CBT (female-specific cognitive behavioral therapy) + UC (usual care) to interact with and provide support to one another	assessed from baseline to 15-months post-baseline follow-up
Secondary	Self-Care Questionnaire	self-report questionnaire used to assess level of self-care	assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up