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Evaluation of a Mobile Phone App for Veterans With PTSD

Primary Purpose

Stress Disorders, Post-Traumatic, Veterans

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized App Coaching
Active Comparator
Sponsored by
VA Palo Alto Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Palo Alto Health Care System Menlo Park Division

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

PTSD Coach with no Coaching

PTSD Coach with Peer Coaching

PTSD Coach with Clinician coaching

PTSD Coach with Automated Coaching

Arm Description

Participants will receive the PTSD coach mobile app.

Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a Veteran peer.

Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a clinical psychologist.

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

Outcomes

Primary Outcome Measures

PTSD Checklist 5
Measures symptoms of post-traumatic stress disorder
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.
Engagement with the Application
Objectively-measured engagement with the intervention (# sessions)

Secondary Outcome Measures

Self-Efficacy for Coping
Self-efficacy for managing symptoms of PTSD using an author-constructed outcome measure.
Perceived Helpfulness of Intervention
How helpful the intervention was for providing information and tools for managing PTSD.

Full Information

First Posted
June 20, 2017
Last Updated
April 24, 2019
Sponsor
VA Palo Alto Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT03199742
Brief Title
Evaluation of a Mobile Phone App for Veterans With PTSD
Official Title
Evaluation of a Mobile Phone App for Veterans With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PTSD Coach with no Coaching
Arm Type
Active Comparator
Arm Description
Participants will receive the PTSD coach mobile app.
Arm Title
PTSD Coach with Peer Coaching
Arm Type
Experimental
Arm Description
Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a Veteran peer.
Arm Title
PTSD Coach with Clinician coaching
Arm Type
Experimental
Arm Description
Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a clinical psychologist.
Arm Title
PTSD Coach with Automated Coaching
Arm Type
Experimental
Arm Description
Participants will receive the PTSD Coach + mobile app which will provide automated, personalized coaching for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Personalized App Coaching
Intervention Description
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
Intervention Name(s)
Active Comparator
Intervention Description
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.
Primary Outcome Measure Information:
Title
PTSD Checklist 5
Description
Measures symptoms of post-traumatic stress disorder
Time Frame
8 weeks
Title
Functional Well-Being
Description
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
Title
Engagement with the Application
Description
Objectively-measured engagement with the intervention (# sessions)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Self-Efficacy for Coping
Description
Self-efficacy for managing symptoms of PTSD using an author-constructed outcome measure.
Time Frame
8 weeks
Title
Perceived Helpfulness of Intervention
Description
How helpful the intervention was for providing information and tools for managing PTSD.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
VA Palo Alto Health Care System Menlo Park Division
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of a Mobile Phone App for Veterans With PTSD

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