AlcoholismPS-Stand DownNCT05473598
Stand Down-Think Before You Drink: An RCT of a Mobile App for Hazardous Drinking With Peer Phone Support
A study testing Stand Down app and Peer-Supported Stand Down in people with Alcoholism, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alcoholism
- What is being tested?
- Stand Down app and Peer-Supported Stand Down
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2022to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210-2716
About this study
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.
Read the detailed description
One in four Veterans presenting to VA primary care screen positive for hazardous drinking. However, due to barriers such as Veterans' stigma about seeking alcohol use treatment and challenges with traveling to VA, most of these Veterans do not receive any alcohol-related care. Mobile applications (apps) are an innovative means of expanding access to alcohol use treatment. The evidence for mobile apps, such as "Step Away", to improve drinking outcomes is emerging. Nevertheless, poor patient engagement remains the Achilles' heel of these apps. Peer Specialists ("Peers") can facilitate Veterans' engagement with mobile apps intended for self-management of hazardous drinking by helping to orient patients to these apps and by providing technical support and accountability. In a VA HSR\&D pilot study, the investigators created a Veteran version of the Step Away app ("Stand Down: Think Before You Drink") and conducted an open trial in which Veterans with hazardous drinking used the app while receiving Peer phone support. The intervention ("Peer-Supported [PS]-Stand Down") was highly acceptable to patients, and patients reported significant improvements in drinking outcomes. These data provide a strong foundation for a larger pragmatic trial to test the effectiveness of the Stand Down app and PS-Stand Down to reduce hazardous drinking among Veterans seen in primary care, relative to the current standard of care that these patients receive.
In the current study, the investigators will evaluate whether the Stand Down app reduces drinking among Veteran primary care patients who engage in hazardous drinking, and for whom PS-Stand Down is more effective than the app alone. Aim 1: Test whether Stand Down (vs. Usual Care; UC) and PS-Stand Down (vs. UC and vs. app only) predicts better drinking outcomes, and test mediators of these effects. Aim 2: Test for differences in satisfaction with care across conditions, and conduct qualitative interviews with patients and PACT staff to understand potential barriers/facilitators to implementing PS-Stand Down in primary care. Aim 3: Explore baseline moderators to elucidate for whom PS-Stand Down (vs. app only) is most beneficial.
In a 3-group RCT at the Palo Alto and Syracuse VAs, 274 Veteran primary patients who screen positive for hazardous drinking, received a brief intervention following a positive screen, and are not currently in alcohol use treatment will complete a baseline interview, be randomized to either (i) UC, (ii) UC plus Stand Down, or (iii) UC plus PS-Stand Down (four phone sessions with a Peer over 8 weeks to enhance app engagement), and be re-interviewed at 8, 20, and 32 weeks. For Aim 2, the CFIR framework will guide key informant interviews with 12 patients and 12 PACT providers from each site.
- Conditions
- Alcoholism
- Being tested
- Stand Down app, Peer-Supported Stand Down, Usual Care
- Keywords
- Alcohol use disorder, Mobile health, Peer Support
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stand Down appBehavioural
Also called App only
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).
Peer-Supported Stand DownBehavioural
Also called PS-Stand Down
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.
Usual CareOther
Also called UC
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: Behavioral: Peer-Supported Stand Down |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 32 weeks post-baseline
Secondary outcomes (7)
Drinks Per Drinking Day (DPDD)
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 DPDD.
Measured: 32 weeks post-baseline
Heavy Drinking Days (HDD)
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 HDD (i.e., five or more standard drinks for men and four or more standard drinks for women).
Measured: 32 weeks post-baseline
World Health Organization (WHO) drinking risk levels
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 reductions (one- or two-levels) in WHO drinking risk levels.
Measured: 32 weeks post-baseline
Negative Consequences from Drinking
The 15-item Short Index of Problems (SIP) will be used to assess negative consequences from drinking. Items are rated on a 4-pt scale (0=Never, 3 = Daily or Almost Daily), which yields a total score.
Measured: 32 weeks post-baseline
Percent Days Abstinent (PDA)
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 PDA.
Measured: 32 weeks post-baseline
Self-Efficacy to Reduce Drinking
Self-efficacy to reduce drinking will be measured at each time point with the 14-item Situational Confidence Questionnaire (SCQ), which asks patients to rate their level of confidence in resisting alcohol use in a range of tempting situations. Responses are rated on a 6-point scale (0%=Not at all confident, 100%=Very confident) are averaged across items to produce a total score, with higher scores indicating more self-efficacy.
Measured: 32 weeks post-baseline
Readiness to Change Drinking
At each time point, the Readiness Ruler will assess patients' readiness to change drinking (quit or cut down). Responses are measured on a 1 (not ready to change) to 10 (trying to change) scale. Higher readiness to change scores predict better alcohol use outcomes in longitudinal studies.
studies
Measured: 32 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Dec 2022
- Primary completion1 Dec 2025
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Daniel M. Blonigen, PhD MA, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473598
- Sponsor's protocol ID
- IIR 20-093
- Acronym
- PS-Stand Down
- Status last verified
- May 2026
- First submitted
- 22 Jul 2022
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37055201
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stand Down-Think Before You Drink: An RCT of a Mobile App for Hazardous Drinking With Peer Phone Support
- ClinicalTrials.gov ID
- NCT05473598
- Acronym / sponsor ID
- PS-Stand Down / IIR 20-093
- Conditions
- Alcoholism
- Keywords
- Alcohol use disorder, Mobile health, Peer Support
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 234 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
One in four Veterans presenting to VA primary care screen positive for hazardous drinking. However, due to barriers such as Veterans' stigma about seeking alcohol use treatment and challenges with traveling to VA, most of these Veterans do not receive any alcohol-related care. Mobile applications (apps) are an innovative means of expanding access to alcohol use treatment. The evidence for mobile apps, such as "Step Away", to improve drinking outcomes is emerging. Nevertheless, poor patient engagement remains the Achilles' heel of these apps. Peer Specialists ("Peers") can facilitate Veterans' engagement with mobile apps intended for self-management of hazardous drinking by helping to orient patients to these apps and by providing technical support and accountability. In a VA HSR\&D pilot study, the investigators created a Veteran version of the Step Away app ("Stand Down: Think Before You Drink") and conducted an open trial in which Veterans with hazardous drinking used the app while receiving Peer phone support. The intervention ("Peer-Supported [PS]-Stand Down") was highly acceptable to patients, and patients reported significant improvements in drinking outcomes. These data provide a strong foundation for a larger pragmatic trial to test the effectiveness of the Stand Down app and PS-Stand Down to reduce hazardous drinking among Veterans seen in primary care, relative to the current standard of care that these patients receive.
In the current study, the investigators will evaluate whether the Stand Down app reduces drinking among Veteran primary care patients who engage in hazardous drinking, and for whom PS-Stand Down is more effective than the app alone. Aim 1: Test whether Stand Down (vs. Usual Care; UC) and PS-Stand Down (vs. UC and vs. app only) predicts better drinking outcomes, and test mediators of these effects. Aim 2: Test for differences in satisfaction with care across conditions, and conduct qualitative interviews with patients and PACT staff to understand potential barriers/facilitators to implementing PS-Stand Down in primary care. Aim 3: Explore baseline moderators to elucidate for whom PS-Stand Down (vs. app only) is most beneficial.
In a 3-group RCT at the Palo Alto and Syracuse VAs, 274 Veteran primary patients who screen positive for hazardous drinking, received a brief intervention following a positive screen, and are not currently in alcohol use treatment will complete a baseline interview, be randomized to either (i) UC, (ii) UC plus Stand Down, or (iii) UC plus PS-Stand Down (four phone sessions with a Peer over 8 weeks to enhance app engagement), and be re-interviewed at 8, 20, and 32 weeks. For Aim 2, the CFIR framework will guide key informant interviews with 12 patients and 12 PACT providers from each site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Stand Down app, Behavioral: Peer-Supported Stand Down, Other: Usual CareAll 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. |
| UC + Stand Down app (app only) | Experimental | Behavioral: Stand Down app, Behavioral: Peer-Supported Stand DownPatients 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). |
| UC + Peer-Supported Stand Down (PS-Stand Down) | Experimental | Behavioral: Peer-Supported Stand DownPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stand Down appAlso: App onlyPatients 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). | Behavioural | UC + Stand Down app (app only), Usual Care |
| Peer-Supported Stand DownAlso: PS-Stand DownPatients 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. | Behavioural | UC + Peer-Supported Stand Down (PS-Stand Down), UC + Stand Down app (app only), Usual Care |
| Usual CareAlso: UCAll 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. | Other | Usual Care |
Primary outcome
Total standard drinks
Time frame: 32 weeks post-baseline
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
7 secondary outcomes
Drinks Per Drinking Day (DPDD)
Time frame: 32 weeks post-baseline
Heavy Drinking Days (HDD)
Time frame: 32 weeks post-baseline
World Health Organization (WHO) drinking risk levels
Time frame: 32 weeks post-baseline
Negative Consequences from Drinking
Time frame: 32 weeks post-baseline
Percent Days Abstinent (PDA)
Time frame: 32 weeks post-baseline
Self-Efficacy to Reduce Drinking
Time frame: 32 weeks post-baseline
Readiness to Change Drinking
Time frame: 32 weeks post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Derived from this study: PubMed 37055201Blonigen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel M. Blonigen, PhD MA principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stand Down app and Peer-Supported Stand Down in people with Alcoholism, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total standard drinks (time frame: 32 weeks post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05473598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.