- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03199742
Evaluation of a Mobile Phone App for Veterans With PTSD
April 24, 2019 updated by: Jason Owen, VA Palo Alto Health Care System
The purpose of this study is to evaluate a mobile phone app designed to help Veterans with PTSD.
Participants in this study will be randomized to receive one of 2 possible mobile phone apps.
The term "randomized" means that which app a participant receives will not be based on any characteristic or behavior of the participant, but will be determined solely by chance like a flip of a coin.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants will receive access to the mobile app "PTSD Coach".
Participants will be randomized (by computerized coin flip) to one of two versions of the mobile app.
All versions of the app will provide comprehensive information and tools for managing trauma symptoms, but one version of the app will provide personalized, confidential coaching messages delivered by either a Veteran peer or clinical psychologist.
Participants will be asked to complete an online survey before using the mobile phone application and again 8 weeks later.
Participants will be provided with the option to complete a telephone interview after 8 weeks of using the mobile phone application.
To be eligible, participants must be a U.S. military Veteran, age 18 or older, have received a previous diagnosis of PTSD, and own an iPhone or iPad device.
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Menlo Park, California, United States, 94025
- VA Palo Alto Health Care System Menlo Park Division
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- U.S. military Veteran
- age 18 or older
- previously diagnosed with PTSD
- own an iPhone or iPad device
Exclusion Criteria:
- no previous history of PTSD
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PTSD Coach with no Coaching
Participants will receive the PTSD coach mobile app.
|
Mobile phone application providing extensive information about PTSD and treatment, tools for managing PTSD symptoms, self-monitoring using the PTSD Checklist, and resources for obtaining support.
|
Experimental: PTSD Coach with Peer Coaching
Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a Veteran peer.
|
All coaching messages will be based on how each participant responds to baseline survey questionnaires and how they interact with the experimental mobile phone application during the course of the study.
Participants will be provided with feedback about recent progress & use of the app, information about coping strategies provided by the app, and a recommendation for making the best use of the app over the subsequent few days.
|
Experimental: PTSD Coach with Clinician coaching
Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a clinical psychologist.
|
All coaching messages will be based on how each participant responds to baseline survey questionnaires and how they interact with the experimental mobile phone application during the course of the study.
Participants will be provided with feedback about recent progress & use of the app, information about coping strategies provided by the app, and a recommendation for making the best use of the app over the subsequent few days.
|
Experimental: PTSD Coach with Automated Coaching
Participants will receive the PTSD Coach + mobile app which will provide automated, personalized coaching for 8 weeks.
|
All coaching messages will be based on how each participant responds to baseline survey questionnaires and how they interact with the experimental mobile phone application during the course of the study.
Participants will be provided with feedback about recent progress & use of the app, information about coping strategies provided by the app, and a recommendation for making the best use of the app over the subsequent few days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD Checklist 5
Time Frame: 8 weeks
|
Measures symptoms of post-traumatic stress disorder
|
8 weeks
|
Functional Well-Being
Time Frame: 8 weeks
|
Measures functional well-being of Veterans across a number of domains, including self-care, romantic relationships, work, family functioning, and parenting.
Subscale scores will be aggregated to create a summary score for this measure.
|
8 weeks
|
Engagement with the Application
Time Frame: 8 weeks
|
Objectively-measured engagement with the intervention (# sessions)
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Efficacy for Coping
Time Frame: 8 weeks
|
Self-efficacy for managing symptoms of PTSD using an author-constructed outcome measure.
|
8 weeks
|
Perceived Helpfulness of Intervention
Time Frame: 8 weeks
|
How helpful the intervention was for providing information and tools for managing PTSD.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
June 20, 2017
First Submitted That Met QC Criteria
June 23, 2017
First Posted (Actual)
June 27, 2017
Study Record Updates
Last Update Posted (Actual)
April 26, 2019
Last Update Submitted That Met QC Criteria
April 24, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-31533
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress Disorders, Post-Traumatic
-
University of California, Los AngelesDefense Advanced Research Projects Agency; Defense Group, Inc.CompletedPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder, ChronicUnited States
-
Weill Medical College of Cornell UniversityCompletedPost-traumatic Stress Disorder | Complex Post-Traumatic Stress DisorderUnited States
-
Oregon Health and Science UniversityNational Center for Complementary and Integrative Health (NCCIH); Oregon Clinical...CompletedPost-Traumatic Stress DisordersUnited States
-
US Department of Veterans AffairsEmory UniversityWithdrawnPost-Traumatic Stress Disorders
-
University of KonstanzGerman Research Foundation; NGO vivo e.V.; GTZ-German Technical Cooperation,... and other collaboratorsCompletedPost-Traumatic Stress DisordersSri Lanka
-
University of California, Los AngelesRecruitingPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder in ChildrenUnited States
-
University of UtahEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedPost-Traumatic Stress Disorder in Children | Post-Traumatic Stress Disorder in AdolescenceUnited States
-
University Hospital, ToulouseCompletedPost-traumatic StressFrance
-
University Hospital, LilleNot yet recruiting
-
Steinn SteingrimssonRecruiting
Clinical Trials on Active Comparator
-
TiumBio Co., Ltd.RecruitingEndometriosisCzechia, Italy, Russian Federation, Poland, Ukraine
-
Eisai Inc.CompletedAlzheimer's DiseaseUnited States
-
Stanford UniversityRecruitingTreatment Resistant Depression | Bipolar II Disorder, Most Recent Episode Major Depressive | Current Depressive EpisodeUnited States
-
United States Naval Medical Center, San DiegoTerminatedPTSD - Post Traumatic Stress Disorder
-
Case Western Reserve UniversityHighland Instruments, Inc.Recruiting
-
Eisai Inc.CompletedHealthy | Drug AbuseCanada
-
Cognition TherapeuticsRecruitingAge-Related Macular DegenerationUnited States
-
AnchorDx Medical Co., Ltd.Peking University First Hospital; Peking Union Medical College Hospital; Peking... and other collaboratorsRecruitingUpper Tract Urothelial CarcinomaChina
-
Case Western Reserve UniversityHighland Instruments, Inc.RecruitingDiabetic Neuropathies | Chronic PainUnited States
-
Medical University InnsbruckBarmherzige Brüder Vienna; Tiroler Landeskrankenanstalten GmbH (TILAK); Tiroler... and other collaboratorsCompletedStroke | Ischemic Attack, Transient | Cost-Benefit Analysis | Secondary Prevention | Disease ManagementAustria