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| ID | Type | Description | Link |
|---|---|---|---|
| K01AA031524-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The goal of this study is to develop and test a brief behavioral treatment for women Veterans with alcohol use in primary care. The study involves a development phase, an open trial phase, and a pilot randomized controlled trial. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief intervention for unhealthy alcohol use | Experimental | Participants in this arm will attend 4-6 30-minute behavioral health appointments with a behavioral health provider in an integrated primary care setting. All participants will attend 4 core alcohol-focused appointments focused on providing information and skills to manage unhealthy alcohol use. Participants may elect to attend up to 2 additional optional appointments focused on supplemental strategies to manage alcohol use or to address co-occurring mental and behavioral health concerns. |
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| Usual Care | Active Comparator | Primary care usual care consists of universal annual alcohol screening; those who are identified as at-risk receive a brief advice intervention from their primary care provider and may be offered an integrated primary care referral. The brief advice intervention is standardized and triggered automatically by a positive screen. Integrated primary care consists of brief assessment and intervention with licensed, independent behavioral health providers. Patients may decline integrated primary care referrals, complete several appointments, and/or be referred to specialty treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary Care | Behavioral | The intervention consists of 4-6 30-minute behavioral health appointments with a behavioral health provider in an integrated primary care setting. It includes 4 core alcohol-focused appointments focused on providing information and skills to manage unhealthy alcohol use that have been adapted from existing evidence-based treatments in integrated primary care and specialty care. Participants may elect to attend up to 2 additional optional appointments focused on supplemental strategies to manage alcohol use or to address co-occurring mental and behavioral health concerns, including mood, trauma, sleep, and pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in self-reported quality of life from baseline to 6-months post-treatment | Quality of life will be assessed by the abbreviated World Health Organization Quality of Life Assessment (WHOQOL-BREF), a 26-item self-report measure of QoL in the past 2 weeks in 4 areas (social, physical, psychological, and environment) on a 1-5 scale. | From baseline to 6 months post-treatment |
| Change in self-reported alcohol-related problems from baseline to 6 months post-treatment | Alcohol problems will be assessed by the Short Inventory of Problems-Revised (SIP-R)147, a 17-item self-report measure of frequency of alcohol problems on a 0-3 scale. | From baseline to 6 months post-treatment |
| Change in self-reported alcohol-related functional impairment from baseline to 6 months post-treatment | Alcohol-specific functional impairment will be assessed by the Addiction Severity Index - Lite, a semi-structured interview developed among Veterans in substance use treatment that assesses alcohol and drug use and problems and 5 areas of functioning: medical, legal, psychiatric, employment, and family/social | Baseline to 6 months post-treatment |
| Feasibility - average session length | Length of sessions in the experimental condition will be measured to test if the average is within guidelines for integrated primary care treatment (30 minutes maximum). | For the duration of the intervention period, 8-12 weeks post-baseline. |
| Intervention fidelity | An independent rater will listen to session tapes and record if each essential element was delivered on a checklist. | For the duration of the intervention period, 8-12 weeks post-baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported change in alcohol consumption from baseline to 6 months post-treatment | Alcohol use will be assessed with the Timeline Followback (TLFB), a calendar-based measure that records standard drinks consumed each day in the past month to yield percent of drinking days, average drinks per drinking day, percent of heavy drinking (i.e., ≥4 drinks/occasion) days, and a variable indicating if alcohol use is above NIAAA-recommendations. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katherine A Buckheit, PhD | Contact | 315-425-4400 | 56742 | katheirne.buckheit@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Katherine A Buckheit, PhD | Veterans Health Research Institute of Central New York, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syracuse VA Medical Center | Syracuse | New York | 13210 | United States |
Once all data collection is complete and the coded database is finalized, IPD will be shared according to PI discretion. For instance, IPD may be shared to be used in meta-analyses or other review papers. No identifiable participant information will be shared.
The data will be available once the database is finalized and will remain available in the future.
Access to the data can be obtained by emailing the PIs and describing the reason the data is needed.
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D011320 | Primary Health Care |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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| Primary care usual care | Behavioral | Primary care usual care consists of universal annual alcohol screening; those who are identified as at-risk receive a brief advice intervention from their primary care provider and may be offered an integrated primary care referral. The brief advice intervention is standardized and triggered automatically by a positive screen. Integrated primary care consists of brief assessment and intervention with licensed, independent behavioral health providers. Patients may decline integrated primary care referrals, complete several appointments, and/or be referred to specialty treatment |
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| Self-reported patient acceptability of the experimental intervention | Patient acceptability will be assessed with the Client Satisfaction Questionnaire (CSQ), an 8-item self-report measure. Acceptability ratings of at least "moderate" on the majority (5/8) of items on the CSQ will be considered acceptable. | After completing the behavioral health treatment, 8-12 weeks post-baseline. |
| Baseline to 6 months post-treatment |
| D006298 |
| Health Services Administration |