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

Primary Purpose

Alcoholism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stand Down app
Peer-Supported Stand Down
Usual Care
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Alcohol use disorder, Mobile health, Peer Support

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Palo Alto Health Care System, Palo Alto, CARecruiting
  • Syracuse VA Medical Center, Syracuse, NYRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Usual Care

UC + Stand Down app (app only)

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

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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).
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.
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.
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
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.

Full Information

First Posted
July 22, 2022
Last Updated
February 1, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05473598
Brief Title
Stand Down-Think Before You Drink: An RCT of a Mobile App for Hazardous Drinking With Peer Phone Support
Acronym
PS-Stand Down
Official Title
Stand Down-Think Before You Drink: An RCT of a Mobile App for Hazardous Drinking With Peer Phone Support
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
August 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
Alcohol use disorder, Mobile health, Peer Support

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
274 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
UC + Stand Down app (app only)
Arm Type
Experimental
Arm Description
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).
Arm Title
UC + Peer-Supported Stand Down (PS-Stand Down)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stand Down app
Other Intervention Name(s)
App only
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Peer-Supported Stand Down
Other Intervention Name(s)
PS-Stand Down
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Other Intervention Name(s)
UC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total standard drinks
Description
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
Time Frame
32 weeks post-baseline
Secondary Outcome Measure Information:
Title
Drinks Per Drinking Day (DPDD)
Description
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.
Time Frame
32 weeks post-baseline
Title
Heavy Drinking Days (HDD)
Description
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).
Time Frame
32 weeks post-baseline
Title
Percent Days Abstinent (PDA)
Description
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.
Time Frame
32 weeks post-baseline
Title
Negative Consequences from Drinking
Description
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.
Time Frame
32 weeks post-baseline
Title
Readiness to Change Drinking
Description
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
Time Frame
32 weeks post-baseline
Title
Self-Efficacy to Reduce Drinking
Description
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.
Time Frame
32 weeks post-baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel M Blonigen, PhD MA
Phone
(650) 493-5000
Ext
27828
Email
Daniel.Blonigen@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer S Smith, MPH
Phone
(650) 493-5000
Ext
27831
Email
jennifer.s.smith@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel M. Blonigen, PhD MA
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren H Gee, JD
Phone
650-493-5000
Ext
66029
Email
Lauren.Gee@va.gov
First Name & Middle Initial & Last Name & Degree
Jennifer S Lee, MD PhD MA
Phone
(650) 493-5000
Ext
68200
Email
jennifer.lee23@va.gov
First Name & Middle Initial & Last Name & Degree
Daniel M. Blonigen, PhD MA
Facility Name
Syracuse VA Medical Center, Syracuse, NY
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210-2716
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyle Possemato, PhD
Phone
315-425-4400
Ext
53551
Email
kyle.possemato@va.gov
First Name & Middle Initial & Last Name & Degree
Kyle Possemato, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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