Clinical trial NCT06118346: A Female-Specific CBT Group for Veteran Women With Alcohol Use Disorder in VA Primary Care Settings
Official title: A Female-Specific Cognitive Behavioral Therapy Group for Alcohol Use Disorder in VA Primary Care Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Risky Health Behavior
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-11-07
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up
measure: Structured Clinical Interview for DSM Disorders (SCID) Alcohol Use Disorder Module
timeFrame: assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up
measure: Form 90 Timeline Followback (TLFB)
timeFrame: assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up
measure: Treatment Services Review (TSR)
timeFrame: assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up
measure: Electronic Medical Record (EMR)
timeFrame: assessed from baseline to 15-months post-baseline follow-up
Secondary outcomes:
measure: Outcome Questionnaire-45
timeFrame: assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up
measure: Posttraumatic Stress Disorder Checklist (PCL)-5 with Life Events Checklist (LEC)-5
timeFrame: assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up
measure: Coping Strategies Scale (CSS)
timeFrame: assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up
measure: Important People Interview (IPI)
timeFrame: assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up
measure: Sociotropy Autonomy Scale (SAS)
timeFrame: assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up
measure: Use of Women2Women mobile application
timeFrame: assessed from baseline to 15-months post-baseline follow-up
measure: Self-Care Questionnaire
timeFrame: assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up
Other outcomes:
Locations:
city: New York
country: United States
facility: VA New York Harbor Healthcare System
state: New York
Study officials:
affiliation: University of Massachusetts Chan Medical School
name: Elizabeth E Epstein, PHD
role: PRINCIPAL_INVESTIGATOR
References: