Alcohol Related Risk Reduction in Veterans

January 9, 2025 updated by: Mark Vander Weg, Iowa City Veterans Affairs Medical Center

Alcohol Related Risk Reduction in Rural Veterans

This project is designed to refine and evaluate the feasibility and preliminary effectiveness of a brief, telephone-administered alcohol risk reduction intervention for Veterans.

Study Overview

Status

Not yet recruiting

Conditions

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

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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