Pilot Evaluation of the VetChange Mobile App for Veterans With PTSD Who Engage in Problem Drinking
Primary Purpose
Alcohol Abuse, Post-Traumatic Stress Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VetChange
web-based drinking assessment and feedback tool (AFT)
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Abuse
Eligibility Criteria
Inclusion Criteria:
- self-reported status as OEF or OIF veteran,
- age between 18 and 65 years,
- moderate levels of nondependent problem drinking as determined by score on the Alcohol Use Disorders Identification Test (AUDIT; Babor, de la Fuente, Saunders, & Grant, 1992; Bradley et al., 2003) between 8 and 25 for men and 5 and 25 for women,
- drinking above guidelines for safer drinking during the 30 days prior to screening based on the Quick Drink Screen (L. C. Sobell et al., 2003; no more than 4 drinks per occasion or 14 drinks per week for men and no more than three drinks per occasion or seven drinks per week for women; Dawson, Grant, & Li, 2005; U.S. Department of Health and Human Services & U.S. Department of Agriculture, 2010), and
- willing to provide an e-mail address for reminders and incentives.
Exclusion Criteria:
(a) high alcohol problem severity
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Assessment only
VetChange mobile app
AFT + VetChange mobile app + supportive accountability tool
Arm Description
Outcomes
Primary Outcome Measures
Quick Drink Screen (QDS; Sobell et al., 2003)
4-item self-report measure of alcohol consumption focused on quantity and frequency of drinking in the last 30 days
PTSD Checklist-5 (PCL-5; Weathers et al., 2010)
20-item self-report measure of PTSD symptoms
Secondary Outcome Measures
The Short Inventory of Problems (SIP; Miller, Tonigan, & Longabaugh, 1995)
15-item, self-report of alcohol-related problems
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03208738
Brief Title
Pilot Evaluation of the VetChange Mobile App for Veterans With PTSD Who Engage in Problem Drinking
Official Title
Pilot Evaluation of the VetChange Mobile App for Veterans With PTSD Who Engage in Problem Drinking
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2017 (Anticipated)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eric Kuhn
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Concept: Alcohol misuse is common among Veterans with PTSD. It has been proposed that this high comorbidity is the result of "self-medication," with alcohol being used to alleviate common PTSD symptoms (e.g., hyperarousal, sleep problems). Given this high prevalence and functional relationship, researchers at the BSD of the NCPTSD developed the VetChange self-management website to concurrently address these conditions. In a large scale RCT, VetChange has shown efficacy to reduce both alcohol misuse and PTSD symptoms. Unfortunately, the recently launched publicly available VetChange website (Vetchange.org) has been plagued by a high rate of visitors not completing the mandatory registration process, which is required for repeated use. Based on the promising findings of the VetChange research, the D&T Division partnered with the BSD Division to develop the VetChange mobile app, which is set to be released to the public very soon. However, unlike the VetChange website, the app has not yet been evaluated and has the advantage of allowing users to easily obtain it without having to register and repeatedly log on through an Internet connection.
This research partnership between the D&T and BSD Divisions will extend and enhance an ongoing successful cross-center collaboration in a high priority topic for the larger Center. The purpose of this proposal is to conduct a pilot evaluation of the VetChange mobile app in order to test its feasibility, acceptability, and potential efficacy to reduce alcohol consumption, PTSD severity, and improve psychosocial functioning among Veterans with PTSD who exhibit signs of problem drinking. In this study, 280 Veterans with problem drinking and clinically significant PTSD symptoms will be recruited using social media and randomized in equal numbers to receive one of four conditions: 1) Assessment only, 2) VetChange mobile app only, 3) AFT plus the VetChange mobile app supplemented with a package of supportive accountability tools (VetChange+). In addition to receiving the mobile app, VetChange+ participants will receive SMS reminders to log drinking behavior using the mobile app. The investigators will track objective use of the VetChange mobile app to assess feasibility, and this usage data will also be used in real-time to tailor the content of text messages provided to participants in the VetChange+ condition. Participants will complete measures of alcohol use, functional well-being, and PTSD symptoms at baseline and again after 8 weeks (posttreatment). At post-treatment, participants in the VetChange app arms of the study will also be asked to report their level of satisfaction with the app and to complete a brief qualitative evaluation of their experience using the VetChange mobile app.
Results of this pilot study will be used to characterize the feasibility, acceptability, and potential efficacy of a mobile app-based self-management intervention to reduce problem drinking behavior in Veterans with PTSD, will inform optimization of the intervention, and will serve as the foundation for subsequent proposals for extramural funding.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Post-Traumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
NA: All study measures are self-report.
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Assessment only
Arm Type
No Intervention
Arm Title
VetChange mobile app
Arm Type
Experimental
Arm Title
AFT + VetChange mobile app + supportive accountability tool
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
VetChange
Intervention Description
VetChange is a self-management mobile application designed to to concurrently reduce both alcohol misuse and PTSD symptoms.
Intervention Type
Behavioral
Intervention Name(s)
web-based drinking assessment and feedback tool (AFT)
Intervention Description
Program will administer a comprehensive assessment of drinking and consequences of drinking, and will provide normative feedback and highlight negative consequences of drinking.
Primary Outcome Measure Information:
Title
Quick Drink Screen (QDS; Sobell et al., 2003)
Description
4-item self-report measure of alcohol consumption focused on quantity and frequency of drinking in the last 30 days
Time Frame
8 weeks
Title
PTSD Checklist-5 (PCL-5; Weathers et al., 2010)
Description
20-item self-report measure of PTSD symptoms
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The Short Inventory of Problems (SIP; Miller, Tonigan, & Longabaugh, 1995)
Description
15-item, self-report of alcohol-related problems
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
self-reported status as OEF or OIF veteran,
age between 18 and 65 years,
moderate levels of nondependent problem drinking as determined by score on the Alcohol Use Disorders Identification Test (AUDIT; Babor, de la Fuente, Saunders, & Grant, 1992; Bradley et al., 2003) between 8 and 25 for men and 5 and 25 for women,
drinking above guidelines for safer drinking during the 30 days prior to screening based on the Quick Drink Screen (L. C. Sobell et al., 2003; no more than 4 drinks per occasion or 14 drinks per week for men and no more than three drinks per occasion or seven drinks per week for women; Dawson, Grant, & Li, 2005; U.S. Department of Health and Human Services & U.S. Department of Agriculture, 2010), and
willing to provide an e-mail address for reminders and incentives.
Exclusion Criteria:
(a) high alcohol problem severity
12. IPD Sharing Statement
Learn more about this trial
Pilot Evaluation of the VetChange Mobile App for Veterans With PTSD Who Engage in Problem Drinking
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