Female-Specific CBT for Veteran Women With AUD
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The purpose of this study is to evaluate the impact of a single-gender Female-Specific Cognitive Behavioral Therapy (CBT) group that uses a therapy manual adapted for female veterans with AUD. The investigators hypothesize that participants assigned to the group (+usual care) will have better linkage to treatment and better outcomes (for percent drinking days, percent heavy drinking days, social support for abstinence, drug use, mental health, healthcare behaviors) compared to participants receiving usual care only.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Female-Specific Cognitive Behavioral Therapy 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)
FS-CBT is a unique 12-session weekly group CBT treatment designed for women Veterans with AUD, 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.
Behavioral: Usual Care
Usual care means that participants will receive brief alcohol counseling and have access to available treatments for AUD at the VA.
|
| Active Comparator: Usual Care Participants in this arm will receive usual VA care for alcohol use disorder. |
Behavioral: Usual Care
Usual care means that participants will receive brief alcohol counseling and have access to available treatments for AUD at the VA.
|
Outcome Measures
Primary Outcome Measures
- Alcohol Use Disorders Identification Test (AUDIT) [assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up]
10-item screening tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems
- SCID (Structured Clinical Interview for DSM Disorders) Alcohol Use Disorder Module [assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up]
semi-structured interview that assesses for alcohol use disorder based on the Diagnostic and Statistical Manual for Mental Disorders (DSM)
- Form 90 Timeline Followback (TLFB) [assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up]
interview used to assess alcohol and drug use over a specific period of time
- Treatment Services Review (TSR) [assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up]
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
- Electronic Medical Record (EMR) [assessed from baseline to 15-months post-baseline follow-up]
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
Secondary Outcome Measures
- Outcome Questionnaire-45 [assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up]
self-report questionnaire used to rate symptoms, interpersonal problems, and social role dysfunction
- PCL (posttraumatic stress disorder checklist)-5 with LEC (life events checklist)-5 [assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up]
combined self-report questionnaire and interview used to measure posttraumatic stress disorder symptoms
- Difficulties in Emotion Regulation Scale (DERS) [assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up]
self-report questionnaire that assesses emotion regulation
- Coping Strategies Scale (CSS) [assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up]
self-report questionnaire used to assess use of coping strategies
- Important People Interview [assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up]
interview used to assess social network characteristics
- Sociotropy Autonomy Scale [assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up]
self-report questionnaire used to assess the two personality dimensions of sociotropy and autonomy
- Use of Women2Women mobile application [assessed from baseline to 15-months post-baseline follow-up]
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
- Self-Care Questionnaire [assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up]
self-report questionnaire used to assess level of self-care
Eligibility Criteria
Criteria
Inclusion Criteria:
-
woman
-
aged 18 or older
-
Veteran of the U.S. Armed Forces
-
enrolled in healthcare at VA New York Harbor Healthcare System (NYHHS)
-
AUDIT-C ≥3 plus diagnosis of AUD on more detailed screening
-
consumed alcohol within 90 days prior to our study's initial eligibility screen
-
proficient in speaking and reading English at the 8th grade level
Exclusion Criteria:
-
participant is acutely suicidal and/or has acute psychotic or manic symptoms associated with severe mental illness
-
pregnant women
-
prisoners
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA New York Harbor Healthcare System | New York | New York | United States | 10010 |
Sponsors and Collaborators
- University of Massachusetts, Worcester
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
- Principal Investigator: Elizabeth E Epstein, PHD, University of Massachusetts Chan Medical School
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H00021304
- 1R01AA028240-01A1