- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06768684
Alcohol Related Risk Reduction in Veterans
Alcohol Related Risk Reduction in Rural Veterans
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will investigate whether a brief alcohol harm reduction intervention for Veteran primary care patients who consume alcohol at levels that exceed dietary guidelines but who do not necessarily exhibit evidence of alcohol use and dependence is feasible based on enrollment and retention rates, and treatment satisfaction. In addition, we will investigate whether there is preliminary evidence for efficacy of the intervention based on changes in alcohol consumption over time.
Following enrollment in the study, participants will be scheduled for an initial phone session. Veterans will then receive an alcohol risk reduction intervention that is based on VA/DoD Clinical Practice Guidelines and strategies recommended by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). The intervention will be delivered via telephone. After an introduction and overview of the intervention, Veterans will be provided with personalized feedback regarding potential health risks associated with their alcohol use and how alcohol use may interact with their health conditions and medications. Following a motivational enhancement exercise, Veterans are advised to reduce alcohol intake to within recommended limits and are supported in identifying a drinking goal. Consistent with principles of harm reduction, the approach starts by "meeting the Veteran where they are" and establishing a collaborative and empowering relationship that leverages the individual's skills. Rather than requiring participants to work toward abstinence, Veterans select their own treatment goals. Evidence-based strategies for achieving the goal are discussed (e.g., goal setting, self-monitoring, identifying and avoiding triggers, dealing with urges, pacing and spacing drinks, managing high risk situations, finding alternatives to alcohol, developing refusal skills, and enlisting social support). Educational materials addressing methods for cutting down are also provided, along with information about other available resources to support their efforts. Progress is monitored at a subsequent contact. Small, incremental gains are reinforced and recognized as steps in the right direction. Problem solving is used to address barriers to change, and revised goals are discussed as appropriate.
Participants will complete baseline questionnaires as well as a post-treatment evaluations (at approximately three months) and follow-up questionnaires at six months post baseline. Data collection will occur by phone unless the participant requests a hard copy survey to be mailed.
Some study participants will also be selected for a separate phone call to ask additional questions about their experience with the coaching sessions, such as what they liked and didn't like about the phone calls, and what things about them were the most and least helpful.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mark Vander Weg Investigator, PhD
- Phone Number: 319-467-1377
- Email: mark.vanderweg@va.gov
Study Contact Backup
- Name: David Hernandez Project Coordinator, BA
- Phone Number: 63-7555 319-338-0581
- Email: david.hernandez3@va.gov
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Veteran status, English-speaking, report current alcohol use, receiving treatment through the Iowa City VA Health Care System
Exclusion Criteria:
- History of significant alcohol withdrawal, evidence of significant alcohol dependence, lack of regular access to a telephone, inability to participate in phone counseling
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active intervention
Veterans will receive a two-session telephone-administered alcohol risk reduction intervention.
|
Participants receive a two-session phone-based alcohol risk reduction intervention based on principles of harm reduction.
Participants receive personalized feedback regarding how alcohol use may impact their health.
Following a motivational enhancement exercise, participants are advised to reduce alcohol intake to within recommended limits.
Evidence-based strategies are discussed (e.g., goal setting, self-monitoring, identifying and avoiding triggers, dealing with urges, pacing and spacing drinks, managing high risk situations, finding alternatives to alcohol, developing refusal skills, and enlisting social support).
Educational materials addressing methods for cutting down are also provided, along with information about other available resources to support their efforts.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alcohol consumption
Time Frame: 30-days
|
Past 30-day alcohol consumption will be assessed using the Alcohol Timeline Follow-back method.
|
30-days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NOMAD 4130
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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