Evaluation of a Mobile Phone App for Veterans With PTSD

NCT ID: NCT03199742

Last Updated: 2019-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stress Disorders, Post-Traumatic Veterans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomized to receive one of 2 forms of the mobile phone application being tested in this study: with and without personalized coaching. Among those who receive coaching, participants will receive either peer-based coaching messages, clinician-based coaching messages, or automated messages.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PTSD Coach with no Coaching

Participants will receive the PTSD coach mobile app.

Group Type ACTIVE_COMPARATOR

Active Comparator

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Personalized App Coaching

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Personalized App Coaching

Intervention Type BEHAVIORAL

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.

PTSD Coach with Automated Coaching

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

Group Type EXPERIMENTAL

Personalized App Coaching

Intervention Type BEHAVIORAL

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.

Interventions

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Personalized 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.

Intervention Type BEHAVIORAL

Active 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Palo Alto Health Care System

FED

Sponsor Role lead

Responsible Party

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Jason Owen

Clinical Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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VA Palo Alto Health Care System Menlo Park Division

Menlo Park, California, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-31533

Identifier Type: -

Identifier Source: org_study_id

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