Alcohol AbuseNCT03208738
Pilot Evaluation of the VetChange Mobile App for Veterans With PTSD Who Engage in Problem Drinking
A study testing VetChange and web-based drinking assessment and feedback tool (AFT) in people with Alcohol Abuse and Post-Traumatic Stress Disorder, run by Eric Kuhn.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Abuse, Post-Traumatic Stress Disorder
- What is being tested?
- VetChange and web-based drinking assessment and feedback tool (AFT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- high alcohol problem severity
About this study
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.
- Conditions
- Alcohol Abuse, Post-Traumatic Stress Disorder
- Being tested
- VetChange, web-based drinking assessment and feedback tool (AFT)
- Medical subject headings
- Alcoholism, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VetChangeBehavioural
VetChange is a self-management mobile application designed to to concurrently reduce both alcohol misuse and PTSD symptoms.
web-based drinking assessment and feedback tool (AFT)Behavioural
Program will administer a comprehensive assessment of drinking and consequences of drinking, and will provide normative feedback and highlight negative consequences of drinking.
| Study group | Role | What they receive |
|---|---|---|
| Assessment only | No intervention | Not described |
| VetChange mobile app | Experimental | Not described Receives: Behavioral: VetChange |
| AFT + VetChange mobile app + supportive accountability tool | Experimental | Not described Receives: Behavioral: VetChange; Behavioral: web-based drinking assessment and feedback tool (AFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
PTSD Checklist-5 (PCL-5; Weathers et al., 2010)
20-item self-report measure of PTSD symptoms
Measured: 8 weeks
Secondary outcomes (1)
The Short Inventory of Problems (SIP; Miller, Tonigan, & Longabaugh, 1995)
15-item, self-report of alcohol-related problems
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study startJul 2017 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eric Kuhn
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Eric Kuhn, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208738
- Sponsor's protocol ID
- IRB-38085
- Status last verified
- Jul 2017
- First submitted
- 30 Jun 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of the VetChange Mobile App for Veterans With PTSD Who Engage in Problem Drinking
- ClinicalTrials.gov ID
- NCT03208738
- Acronym / sponsor ID
- IRB-38085
- Conditions
- Alcohol Abuse, Post-Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Eric KuhnUS federal agency
- Study start
- Jul 2017 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Assessment only | No intervention | – |
| VetChange mobile app | Experimental | Behavioral: VetChange |
| AFT + VetChange mobile app + supportive accountability tool | Experimental | Behavioral: VetChange, Behavioral: web-based drinking assessment and feedback tool (AFT) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- high alcohol problem severity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VetChangeVetChange is a self-management mobile application designed to to concurrently reduce both alcohol misuse and PTSD symptoms. | Behavioural | AFT + VetChange mobile app + supportive accountability tool, VetChange mobile app |
| 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. | Behavioural | AFT + VetChange mobile app + supportive accountability tool |
Primary outcome
Quick Drink Screen (QDS; Sobell et al., 2003)
Time frame: 8 weeks
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)
Time frame: 8 weeks
20-item self-report measure of PTSD symptoms
1 secondary outcome
The Short Inventory of Problems (SIP; Miller, Tonigan, & Longabaugh, 1995)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing VetChange and web-based drinking assessment and feedback tool (AFT) in people with Alcohol Abuse and Post-Traumatic Stress Disorder, run by Eric Kuhn.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick Drink Screen (QDS; Sobell et al., 2003) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.