CClinicalTrials.gg
CompletedNCT03199742Updated Apr 26, 2019

Evaluation of a Mobile Phone App for Veterans With PTSD

An interventional study of Personalized App Coaching and Active Comparator in Stress Disorders, Post-Traumatic and Veterans, sponsored by VA Palo Alto Health Care System. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-26.

Sponsored by VA Palo Alto Health Care System · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Stress Disorders, Post-Traumatic
  • Veterans
03

In context

Stress Disorders, Post-Traumatic

2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.

This study's enrollment of 101 is above the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

VA Palo Alto Health Care System is the lead sponsor of 42 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • U.S. military Veteran
  • age 18 or older
  • previously diagnosed with PTSD
  • own an iPhone or iPad device

Exclusion criteria

Exclusion Criteria:

  • no previous history of PTSD
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
101 participants (actual)

Study arms

  • Active comparator
    PTSD Coach with no Coaching

    Participants will receive the PTSD coach mobile app.

    Behavioral: Active Comparator

  • 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.

    Behavioral: Personalized App Coaching

  • 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.

    Behavioral: Personalized App Coaching

  • Experimental
    PTSD Coach with Automated Coaching

    Participants will receive the PTSD Coach + mobile app which will provide automated, personalized coaching for 8 weeks.

    Behavioral: Personalized App Coaching

Interventions

  • BehavioralPersonalized App Coaching

    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.

  • BehavioralActive Comparator

    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.

06

What researchers measure

Primary outcomes

  1. PTSD Checklist 5

    Measures symptoms of post-traumatic stress disorder

    Time frame: 8 weeks

  2. Functional Well-Being

    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.

    Time frame: 8 weeks

  3. Engagement with the Application

    Objectively-measured engagement with the intervention (# sessions)

    Time frame: 8 weeks

Secondary outcomes

  1. Self-Efficacy for Coping

    Self-efficacy for managing symptoms of PTSD using an author-constructed outcome measure.

    Time frame: 8 weeks

  2. Perceived Helpfulness of Intervention

    How helpful the intervention was for providing information and tools for managing PTSD.

    Time frame: 8 weeks

07

Study locations

1 site
  • VA Palo Alto Health Care System Menlo Park Division
    Menlo Park, California 94025, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03199742
Lead sponsor
VA Palo Alto Health Care System
Responsible party
Jason Owen (Clinical Psychologist, VA Palo Alto Health Care System) — Principal investigator
First posted
Jun 27, 2017
Start date
Jul 1, 2017
Primary completion
Dec 1, 2018
Completion
Mar 1, 2019
Last update
Apr 26, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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