Alcohol Drinking Clinical Trial
Official title:
Multi-site Pilot Trial of Strengths-based Linkage to Alcohol Care (SLAC) for Hazardous Drinkers in Primary Care
This pilot study will determine the feasibility, acceptability, and efficacy of Strengths-based Linkage to Alcohol Care (SLAC; a behavioral intervention) to link Veterans, identified as hazardous drinkers in VHA primary care, to alcohol care. Participants screening positive in VA primary care for hazardous drinking and posttraumatic stress disorders (PTSD) and/or depression in the past year will be recruited. Participants will be randomly assigned to one of two study conditions - SLAC plus usual care or usual care only. The investigators will determine the feasibility of conducting a larger scale study to evaluate SLAC in primary care and SLAC's acceptability among key stakeholders (e.g., Veterans, primary care providers). Other outcomes will include exploring whether SLAC improves linkage to an alcohol care or help option and/or reduces alcohol use and mental health (PTSD, depression) symptoms.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Have screened positive for hazardous drinking (AUDIT-C score > 5) - PTSD (PC-PTSD-5 score > 3) and/or depression (PHQ-2 score > 3) in the prior 12 months and have positive rescreens - Not have received specialty SUD treatment or participated in weekly mutual-help groups in the past 90-days - Not have significant cognitive impairment - Have ongoing access to a mobile or landline telephone - Provide at least one contact who will know the Veteran's contact information Exclusion Criteria: - Not meeting any of the inclusion criteria |
Country | Name | City | State |
---|---|---|---|
United States | Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR | North Little Rock | Arkansas |
United States | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Cucciare MA, Marchant K, Benton C, Hildebrand D, Ghaus S, Han X, Thompson RG, Timko C. Connect To Care (C2C): protocol for two-site randomized controlled pilot trial to improve outcomes for patients with hazardous drinking and PTSD and/or depression sympt — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Linkage to alcohol care | This outcome is a dichotomous variable (yes/no), with "yes" defined as the participant reporting at least one of the following: attended an initial meeting with an outpatient (primary care, specialty care) or residential program; attended a mutual-help group meeting; received > 30-days' supply of AUD medication; or went online to access e-health for alcohol information. | 3-month | |
Primary | Utilization of alcohol care | The investigators will define utilization as the percentage of days, in the past 90-days, that participants obtained any alcohol care. | 3-month | |
Primary | Utilization of alcohol care options | We will measure the total number of alcohol care options participants obtained over the past 90-days; scores will range from 0 (no care) to 4 (obtained all types of care: outpatient/residential, mutual-help, medication (>30-days' supply), e-health). | 3-month | |
Secondary | Alcohol consumption | The quantity and frequency of alcohol consumed will be measured using the 90-day Time Line Follow-Back (TLFB) instrument. The TLFB is a calendar that tracks alcohol consumed each day. We will combine frequency data (days of alcohol consumed) and quantity data (number of drinks consumed each day) to derive a variable measuring harmful drinking days - or days in which alcohol consumed is above NIAAA recommended limits for men and women. | 3-month | |
Secondary | Depression | Depression severity will be measured using the Patient Health Questionnaire-9. Scores range from 0-27. Higher scores indicate more symptoms of depression. | 3-month | |
Secondary | Posttraumatic stress disorder | Posttraumatic stress disorder severity will be measured using the PTSD Checklist-5. Scores range from 0-80, with higher scores indicating more symptoms of PTSD. | 3-month |
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