Evaluation of a Mobile Phone App for Veterans With PTSD

Not Applicable

Completed

• Conditions: Veterans; Stress Disorders, Post-Traumatic
• Interventions: Behavioral: Active Comparator; Behavioral: Personalized App Coaching

• Registration Number: NCT03199742
• Lead Sponsor: VA Palo Alto Health Care System

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.

Study Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-23
• Study First Posted: 2017-06-27
• Study Start: 2017-07-01
• Primary Completion: 2018-12-01
• Study Completion: 2019-03-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTSD Coach with no Coaching	Active Comparator	Participants will receive the PTSD coach mobile app.
PTSD Coach with Automated Coaching	Personalized App Coaching	Participants will receive the PTSD Coach + mobile app which will provide automated, personalized coaching for 8 weeks.
PTSD Coach with Peer Coaching	Personalized App Coaching	Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a Veteran peer.
PTSD Coach with Clinician coaching	Personalized App Coaching	Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a clinical psychologist.

Primary Outcome Measures

Name	Time	Method
PTSD Checklist 5	8 weeks	Measures symptoms of post-traumatic stress disorder
Functional Well-Being	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.
Engagement with the Application	8 weeks	Objectively-measured engagement with the intervention (# sessions)

Secondary Outcome Measures

Name	Time	Method
Self-Efficacy for Coping	8 weeks	Self-efficacy for managing symptoms of PTSD using an author-constructed outcome measure.
Perceived Helpfulness of Intervention	8 weeks	How helpful the intervention was for providing information and tools for managing PTSD.

Trial Locations

Locations (1)

VA Palo Alto Health Care System Menlo Park Division; 🇺🇸 Menlo Park, California, United States