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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
Eric Kuhn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. self-reported status as OEF or OIF veteran,
  2. age between 18 and 65 years,
  3. 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,
  4. 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
  5. 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

    First Posted
    June 30, 2017
    Last Updated
    July 5, 2017
    Sponsor
    Eric Kuhn
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    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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