Stand Down-Think Before You Drink: An RCT of a Mobile App for Hazardous Drinking With Peer Phone Support

NCT05473598 | Active Not Recruiting DMC

• 1 other identifier: IIR 20-093
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 2

Brief Summary

Hazardous drinking is common among Veteran primary care patients and increases risk for more costly and complex medical problems over the long-term. Yet, the vast majority of these Veterans go untreated. By providing an option for care that is easily accessible, private, and self-directed, mobile applications (apps) circumvent many barriers to alcohol use treatment. However, poor patient engagement remains the Achilles' heel of these apps. Through supportive accountability, Peer Specialists can maximize the reach and engagement of these apps with patients and improve drinking outcomes. The goal of this project is to evaluate whether an app for alcohol use self-management ("Stand Down") reduces drinking among Veteran primary care patients who engage in hazardous drinking, and for whom Peer-Supported-Stand Down is more effective than the app alone. If successful, the proposed research has the potential to transform care and increase access to alcohol-related services for Veterans who engage in hazardous drinking but rarely seek treatment, and, in turn, mitigate the adverse health outcomes that stem from untreated hazardous drinking.

Conditions

Alcoholism

Keywords

Alcohol use disorder; Mobile health; Peer Support

Outcome Measures

Primary Outcomes (1)

• Total standard drinks

  At each assessment, the Timeline Follow Back (TLFB), a retrospective, calendar-based measure, will provide information on quantity/frequency of alcohol use in the past 30 days. Information gathered from this reliable and well-validated measure will be used to calculate total standard drinks

  32 weeks post-baseline

Secondary Outcomes (8)

• Drinks Per Drinking Day (DPDD)

  32 weeks post-baseline

• Heavy Drinking Days (HDD)

  32 weeks post-baseline

• World Health Organization (WHO) drinking risk levels

  32 weeks post-baseline

• Drinks Per Week

  32 weeks post-baseline

• Negative Consequences from Drinking

  32 weeks post-baseline

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

All patients, regardless of condition, will have access to usual care for hazardous drinking in primary care. In this setting, usual care entails a spectrum of alcohol-related services including annual screening for hazardous drinking, brief intervention following a positive screen (advice from a provider to reduce their drinking), and referral (as needed) to specialty AUD treatment.

Behavioral: Stand Down app; Behavioral: Peer-Supported Stand Down; Other: Usual Care

UC + Stand Down app (app only)

EXPERIMENTAL

Patients in this condition will receive Usual Care (UC) and be provided a unique code and password to access Stand Down. The app is based on principles of motivational enhancement and cognitive-behavioral therapies and comprises 7 modules organized around 4 goals: 7 modules organized around 4 goals: (i) Enhance awareness of drinking patterns (assessment and personalized feedback), (ii) Establish and monitor progress towards drinking goal - i.e., moderation or abstinence, (iii) Manage cravings and other problems using in-the-moment tools, and (iv) Connect users with other types of support. App usage will be tracked by the research team for the duration of the study (32 weeks).

Behavioral: Stand Down app; Behavioral: Peer-Supported Stand Down

UC + Peer-Supported Stand Down (PS-Stand Down)

EXPERIMENTAL

Patients assigned to this condition will receive UC and access to Stand Down, plus four phone sessions from a Peer over 8 weeks. Sessions will be bi-weekly, approximately 15-30 minutes in length, and focus on enhancing patients' engagement with the app.

Behavioral: Peer-Supported Stand Down

Interventions

Stand Down app BEHAVIORAL

Patients in this condition will receive Usual Care (UC) and be provided a unique code and password to access Stand Down. The app is based on principles of motivational enhancement and cognitive-behavioral therapies and comprises 7 modules organized around 4 goals: 7 modules organized around 4 goals: (i) Enhance awareness of drinking patterns (assessment and personalized feedback), (ii) Establish and monitor progress towards drinking goal - i.e., moderation or abstinence, (iii) Manage cravings and other problems using in-the-moment tools, and (iv) Connect users with other types of support. App usage will be tracked by the research team for the duration of the study (32 weeks).

Also known as: App only

UC + Stand Down app (app only); Usual Care

Peer-Supported Stand Down BEHAVIORAL

Patients assigned to this condition will receive UC and access to Stand Down, plus four phone sessions from a Peer over 8 weeks. Sessions will be bi-weekly, approx. 15-30 minutes in length, and focus on enhancing patients' engagement with the app.

Also known as: PS-Stand Down

UC + Peer-Supported Stand Down (PS-Stand Down); UC + Stand Down app (app only); Usual Care

Usual Care OTHER

All patients, regardless of condition, will have access to usual care for hazardous drinking in primary care. In this setting, usual care entails a spectrum of alcohol-related services including annual screening for hazardous drinking, brief intervention following a positive screen (advice from a provider to reduce their drinking), and referral (as needed) to specialty AUD treatment.

Also known as: UC

Usual Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans will be eligible if they:
• had a positive AUDIT-C screen (score of \> 5) during a primary care visit in the past month at a clinic at either the VA Palo Alto Health Care System or the Syracuse VA Medical Center
• have documentation in their medical records of receipt of a BI following a positive screen
• did not receive any outpatient, inpatient, or residential care for alcohol use in the month after their positive AUDIT-C
• own a smartphone

You may not qualify if:

• Veterans who have active diagnoses of a psychotic disorder or a cognitive disorder (e.g., dementia) will be excluded
• Veterans who do not agree to be randomized will be excluded as well

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210-2716, United States

Location

Related Publications (1)

• Blonigen DM, Hawkins EJ, Kuhn E, Timko C, Dulin PL, Boothroyd D, Possemato K. Stand Down-Think Before You Drink: protocol for an effectiveness-implementation trial of a mobile application for unhealthy alcohol use with and without peer support. BMJ Open. 2023 Apr 13;13(4):e072892. doi: 10.1136/bmjopen-2023-072892.

  PMID: 37055201 RESULT

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Daniel M. Blonigen, PhD MA

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 26, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)