Alcohol Use Disorder Clinical Trial
Official title:
A Female-Specific Cognitive Behavioral Therapy Group for Alcohol Use Disorder in VA Primary Care Settings
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | VA New York Harbor Healthcare System | New York | New York |
Lead Sponsor | Collaborator |
---|---|
University of Massachusetts, Worcester | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
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 |
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