Evaluation of a Mobile Phone App for Veterans With PTSD

Study Overview
=================
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.

Official Title
-----------------
Evaluation of a Mobile Phone App for Veterans With PTSD

Conditions
-----------------
Stress Disorders, Post-Traumatic, Veterans

Intervention / Treatment
-----------------
* Behavioral: Personalized App Coaching
* Behavioral: Active Comparator


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PTSD Coach with no Coaching<br>Participants will receive the PTSD coach mobile app. | Behavioral: Active Comparator<br>* 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.<br>|
| Experimental: PTSD Coach with Peer Coaching<br>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<br>* 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.<br>|
| Experimental: PTSD Coach with Clinician coaching<br>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<br>* 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.<br>|
| Experimental: PTSD Coach with Automated Coaching<br>Participants will receive the PTSD Coach + mobile app which will provide automated, personalized coaching for 8 weeks. | Behavioral: Personalized App Coaching<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist 5 | Measures symptoms of post-traumatic stress disorder | 8 weeks | 
| 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. | 8 weeks | 
| Engagement with the Application | Objectively-measured engagement with the intervention (# sessions) | 8 weeks | 

Secondary Outcome Measures

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