Pilot Evaluation of the VetChange Mobile App for Veterans With PTSD Who Engage in Problem Drinking

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.

Study Overview

• Status: Unknown
• Conditions: Post-Traumatic Stress Disorder; Alcohol Abuse
• Intervention / Treatment: Behavioral: VetChange; Behavioral: web-based drinking assessment and feedback tool (AFT)

• Study Type: Interventional
• Enrollment (Anticipated): 280
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Assessment only
EXPERIMENTAL: VetChange mobile app	Behavioral: VetChange; VetChange is a self-management mobile application designed to to concurrently reduce both alcohol misuse and PTSD symptoms.
EXPERIMENTAL: AFT + VetChange mobile app + supportive accountability tool	Behavioral: VetChange; VetChange is a self-management mobile application designed to to concurrently reduce both alcohol misuse and PTSD symptoms.; Behavioral: web-based drinking assessment and feedback tool (AFT); Program will administer a comprehensive assessment of drinking and consequences of drinking, and will provide normative feedback and highlight negative consequences of drinking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks
PTSD Checklist-5 (PCL-5; Weathers et al., 2010)	20-item self-report measure of PTSD symptoms	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Short Inventory of Problems (SIP; Miller, Tonigan, & Longabaugh, 1995)	15-item, self-report of alcohol-related problems	8 weeks

Collaborators and Investigators

• Sponsor: Eric Kuhn

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2017
• Primary Completion (ANTICIPATED): June 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (ACTUAL): July 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Trauma and Stressor Related Disorders; Alcoholism; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: IRB-38085

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No