Stand Down App + Peer Support for Alcoholism

(PS-Stand Down Trial)

Not currently recruiting at 1 trial location

Overseen By Jennifer S Smith, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Psychotic disorder, Cognitive disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile app called Stand Down can help Veterans reduce hazardous drinking when paired with peer support. The app provides tools and resources to manage drinking habits, while peer support offers additional encouragement. Researchers seek to discover if combining the app with peer support is more effective than using the app alone. Veterans who drink hazardously, have not received specialized alcohol treatment in the past month, and have a smartphone may be suitable candidates for this trial. As an unphased trial, this study offers Veterans a unique opportunity to contribute to innovative research that could lead to new methods for managing drinking habits.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Stand Down app and Peer-Supported Stand Down are safe for use in reducing hazardous drinking among Veterans?

Research has shown that the Stand Down app has been tested in several studies and appears promising for helping people manage their drinking habits. The app uses techniques that encourage motivation and change behavior, which have proven effective. These studies reported no major side effects, suggesting the app is generally safe to use.

For the Peer-Supported Stand Down treatment, which combines the app with peer assistance, complete safety evidence from trials is not yet available. However, peer support in similar contexts has shown effectiveness without major safety issues. This indicates that peer support is usually safe and can aid in behavior change.

Overall, for those considering joining a trial with these treatments, current data suggests they are safe and could help manage drinking habits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments being explored because they leverage technology and peer support to tackle alcoholism in innovative ways. The Stand Down app uses motivational enhancement and cognitive-behavioral therapies to help users become more aware of their drinking habits, set and monitor progress towards goals, and manage cravings in real time, which differs from traditional methods like brief interventions or referrals for specialist treatment. Additionally, the app's integration with peer support, providing bi-weekly phone sessions, adds a personal connection and encouragement that standard care doesn't typically offer. This combination of digital tools and human interaction aims to enhance patient engagement and improve outcomes in managing alcohol use disorder.

What evidence suggests that this trial's treatments could be effective for hazardous drinking?

Research has shown that the Stand Down app, which employs motivational and cognitive-behavioral techniques, may help Veterans reduce their drinking. The app allows users to track their drinking, set goals, manage cravings, and connect with support. In this trial, some participants will receive only the Stand Down app, while others will receive the app with peer support. Early studies suggest that adding peer support enhances the app's effectiveness by maintaining user engagement. Although more data from large trials is needed, initial findings indicate that Veterans find the app and peer support helpful and report reduced drinking. This combination aims to address the common issue of losing interest in standalone apps. ^{1 2 4 6 7}

Who Is on the Research Team?

Daniel M. Blonigen, PhD MA

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Are You a Good Fit for This Trial?

This trial is for Veterans who recently scored high on an alcohol use screening and haven't had treatment for alcohol use in the past month. They must have received brief intervention, own a smartphone, and be willing to be randomly assigned to a group. Those with psychotic or cognitive disorders are not eligible.

Inclusion Criteria

Veterans who did not receive any outpatient, inpatient, or residential care for alcohol use in the month after their positive AUDIT-C

Veterans with documentation in their medical records of receipt of a BI following a positive screen

Veterans with 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

Exclusion Criteria

I am a veteran diagnosed with a psychotic disorder.

Veterans who do not agree to be randomized

I am a veteran diagnosed with a cognitive disorder like dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline interview and are randomized to one of the study conditions

1 week

1 visit (in-person or virtual)

Treatment

Participants use the Stand Down app with or without Peer support, depending on their assigned group

8 weeks

4 phone sessions (bi-weekly) for Peer-Supported group

Follow-up

Participants are monitored for drinking outcomes and other measures

24 weeks

Re-interviews at 8, 20, and 32 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Peer-Supported Stand Down
• Stand Down app

Trial Overview

The study tests if the 'Stand Down' mobile app helps reduce hazardous drinking among Veterans. It compares usual care, the app alone, and the app with peer phone support to see which is more effective at managing alcohol use.

How Is the Trial Designed?

Group I: UC + Stand Down app (app only) Experimental Treatment 2 Interventions

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).

Group II: UC + Peer-Supported Stand Down (PS-Stand Down) Experimental Treatment 1 Intervention

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.

Group III: Usual Care Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

This study will evaluate the effectiveness of a mobile app called 'Stand Down-Think Before You Drink' in reducing unhealthy alcohol use among 274 primary care patients, comparing usual care, app access, and peer-supported app engagement over 32 weeks.

The inclusion of peer support in the intervention aims to enhance patient engagement with the app, which could lead to better drinking outcomes, making it a promising approach for improving alcohol-related care in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Blonigen, DM., Hawkins, EJ., Kuhn, E., et al.[2023]

The Peer-Supported Stand Down app was well-accepted by 31 veteran primary care patients, with participants spending an average of 93.89 minutes in the app and using it on 14 out of 28 days during the four-week study.

Significant reductions in alcohol consumption were observed, with total standard drinks decreasing from an average of 142.7 to 85.6 over 30 days, indicating that peer support may enhance engagement and effectiveness of mobile alcohol treatment interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using peers to increase veterans' engagement in a smartphone application for unhealthy alcohol use: A pilot study of acceptability and utility. Blonigen, DM., Harris-Olenak, B., Kuhn, E., et al.[2022]

The Drinkaware app, used by over 119,000 people in a 13-month study, effectively supports behavior change in motivated users, leading to reduced alcohol consumption, especially within the first week of use.

Despite its effectiveness, the app experienced high user drop-off after one week, indicating a need for greater personalization and tailored features to enhance long-term engagement and satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a mobile health application to reduce alcohol consumption: a mixed-methods evaluation of the drinkaware track & calculate units application. Attwood, S., Parke, H., Larsen, J., et al.[2022]

The SIDEAL mobile app was well-accepted by 24 adult patients with alcohol dependence, showing high usage rates (80% of study days) and high satisfaction levels, particularly with its self-register and feedback features.

Participants experienced significant reductions in alcohol consumption over 6 weeks, with binge drinking days decreasing from an average of 25 to 5.8 and mean daily consumption dropping from 6.5 to 1.9 standard units, indicating the app's potential efficacy in managing alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management and Shared Decision-Making in Alcohol Dependence via a Mobile App: a Pilot Study. Barrio, P., Ortega, L., López, H., et al.[2018]

A quality assessment of 25 self-tracking smartphone applications for alcohol use revealed that 17 apps scored positively on usability and design, with most performing better than typical health apps, indicating a promising potential for user engagement.

Despite the overall positive design ratings, significant shortcomings were found in interactivity and content quality, highlighting the need for improvements in consumer information, app availability, and evidence-based content to enhance user experience and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Content Quality of Alcohol-Related German, French and Italian Self-Tracking Applications. Klingemann, H., Flückiger, M., Bongard, T., et al.[2021]

A review of 21 studies on 19 unique smartphone apps aimed at reducing alcohol consumption found that while apps for adults show some promise, the evidence is still mixed and inconclusive.

Only four out of eight evaluated apps available in commercial app stores have demonstrated effectiveness in helping users reduce their alcohol consumption, highlighting a gap between research and practical availability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone apps for managing alcohol consumption: a literature review. Colbert, S., Thornton, L., Richmond, R.[2021]

A content analysis of 266 smartphone apps for managing alcohol use revealed that these apps have been downloaded over 2.7 million times, indicating a significant public health reach.

While 60% of the apps provided some level of tailored feedback, the overall extent of this tailoring was limited, suggesting that there is room for improvement in how these apps meet individual user needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

There is an app for that - Or is there? A content analysis of publicly available smartphone apps for managing alcohol use. Hoeppner, BB., Schick, MR., Kelly, LM., et al.[2022]

A review identified six smartphone apps aimed at reducing alcohol consumption or treating alcohol use disorder (AUD), with only two apps (A-CHESS and LBMI-A) showing self-reported reductions in alcohol use.

The study highlights a significant gap in the evaluation of these apps, indicating that while smartphone technology has potential for aiding individuals with AUD, more rigorous testing is needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. Meredith, SE., Alessi, SM., Petry, NM.[2022]

The study involving 379 college students showed that a smartphone app combined with Brief Motivational Interviewing (BMI) effectively reduced alcohol consumption and related consequences, particularly in voluntary participants.

In a controlled trial, participants using the app had a decrease in peak Blood Alcohol Concentration (BAC) compared to those receiving only in-person BMI, highlighting the app's potential as a beneficial tool for alcohol intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Theory-Based mHealth Intervention for High-Risk Drinking in College Students. Kazemi, DM., Borsari, B., Levine, MJ., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10106019/

Stand Down–Think Before You Drink - PubMed Central - NIH

Although promising, the effectiveness of peer-supported use of Stand Down for improving drinking outcomes has yet to be demonstrated in an RCT.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37055201/

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clinicaltrial.be

clinicaltrial.be/fr/details/15818?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Stand Down-Think Before You Drink: An RCT of a Mobile ...

The intervention ("Peer-Supported [PS]-Stand Down") was highly acceptable to patients, and patients reported significant improvements in ...

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psycnet.apa.org

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Using peers to increase veterans' engagement in a ...

A pilot study comparing peer supported web-based CBT to self-managed web CBT for primary care veterans with PTSD and hazardous alcohol use.

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researchgate.net

researchgate.net/publication/370012951_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

(PDF) Stand Down–Think Before You Drink: protocol for an ...

The goal of this hybrid I effectiveness-implementation study is to test a mobile app ('Stand Down–Think Before You Drink'), with and without peer support, to ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2352853217300482

A qualitative exploration of social support during treatment ...

In this analysis we seek to understand the changes of social networks among individuals with severe AUD (n = 33) throughout their recovery process.

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onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/add.16751

Recovery support services as part of the continuum of care ...

A review of evidence from both the mental health and addiction fields found that peer support services produced positive outcomes in two broad ...