- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05473598
Stand Down-Think Before You Drink: An RCT of a Mobile App for Hazardous Drinking With Peer Phone Support (PS-Stand Down)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daniel M Blonigen, PhD MA
- Phone Number: 27828 (650) 493-5000
- Email: Daniel.Blonigen@va.gov
Study Contact Backup
- Name: Jennifer S Smith, MPH
- Phone Number: 27831 (650) 493-5000
- Email: jennifer.s.smith@va.gov
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304-1207
- Recruiting
- VA Palo Alto Health Care System, Palo Alto, CA
-
Contact:
- Jennifer S Lee, MD PhD MA
- Phone Number: 68200 (650) 493-5000
- Email: jennifer.lee23@va.gov
-
Principal Investigator:
- Daniel M. Blonigen, PhD MA
-
Contact:
- Daniel M Blonigen, PhD MA
- Phone Number: 27828 650-493-5000
- Email: Daniel.Blonigen@va.gov
-
-
New York
-
Syracuse, New York, United States, 13210-2716
- Recruiting
- Syracuse VA Medical Center, Syracuse, NY
-
Contact:
- Kyle Possemato, PhD
- Phone Number: 53551 315-425-4400
- Email: kyle.possemato@va.gov
-
Sub-Investigator:
- Kyle Possemato, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual Care
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.
|
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).
Other Names:
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.
Other Names:
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.
Other Names:
|
Experimental: UC + Stand Down app (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).
|
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).
Other Names:
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.
Other Names:
|
Experimental: UC + Peer-Supported Stand Down (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, approximately 15-30 minutes in length, and focus on enhancing patients' engagement with the app.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
32 weeks post-baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drinks Per Drinking Day (DPDD)
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 DPDD.
|
32 weeks post-baseline
|
Heavy Drinking Days (HDD)
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 HDD (i.e., five or more standard drinks for men and four or more standard drinks for women).
|
32 weeks post-baseline
|
Percent Days Abstinent (PDA)
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 PDA.
|
32 weeks post-baseline
|
Negative Consequences from Drinking
Time Frame: 32 weeks post-baseline
|
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.
|
32 weeks post-baseline
|
Readiness to Change Drinking
Time Frame: 32 weeks post-baseline
|
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 |
32 weeks post-baseline
|
Self-Efficacy to Reduce Drinking
Time Frame: 32 weeks post-baseline
|
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.
|
32 weeks post-baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Daniel M. Blonigen, PhD MA, VA Palo Alto Health Care System, Palo Alto, CA
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
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
- IIR 20-093
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
product manufactured in and exported from the U.S.
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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