Use of Mobile Apps for Those With PTSD and Their Partners

Please SUMMARIZE the research procedures, screening through closeout, which the human
subject will undergo. Refer to sections in the protocol attached in section 16, BUT do not
copy the clinical protocol. Be clear on what is to be done for research and what is part of
standard of care.

In brief, the study team will attempt to recruit 100 couples in which one partner is a
community-dwelling Veteran with significant, untreated symptoms of posttraumatic stress
disorder (PTSD) symptoms. All participants will receive access to a mobile app designed by
Veterans Affairs (VA). Veterans will receive access to the PTSD Coach mobile app, and their
partners will receive access to the PTSD Family Coach mobile app. Potential participants
will be identified from targeted Facebook and other social media outreach efforts. Those who
view an advertisement will be directed to the study website, hosted by Stanford's Qualtrics
domain, where they will be provided with information about the study, screened for
eligibility,and then provided with an informed consent document. Upon completing the
informed consent process, participants will be asked to complete a baseline survey and then
to share information about the study with their partner. Veterans and their partners will be
connected only by a subject identification number. After completing the baseline survey, all
participants will then be encouraged to use the PTSD Coach app or the PTSD Family Coach app
as often or as little as they like.

Using random assignment, half of the dyads will also be provided with a) access to a secure,
confidential discussion board, where they will be able to post new messages and respond to
messages posted by others and b) mailed information packages that contain information about
coping with PTSD, coping with a spouse's PTSD, and strategies for managing relationship
distress associated with PTSD. Those dyads who do not receive access to the discussion board
will still receive access to the mobile apps but will not have access to either the
discussion board or the mailed information packages.

Outcomes will be evaluated using objective measures of engagement with the apps, changes in
attitudes toward use of mental health services, relationship quality,changes over time in
PTSD and stress symptoms, and qualitative experiences associated with use of the apps.
Barriers to implementation and identified strategies for overcoming barriers will be
catalogued over the duration of the study.

Description of PTSD Coach:

Participants will be provided with a link to download PTSD Coach (freely available on iTunes
and Google Play Stores or through myvaapps.com) and brief recommendations for how to use the
app over the subsequent 8 weeks of the study. PTSD Coach is a mobile app for iPhone and
Android, developed by the VA National Center for PTSD in collaboration with National Center
for Telehealth and Technology (T2) and the Department of Veterans Affairs Patient Care
Services. PTSD Coach was initially developed and launched in March, 2011, with usability and
focus group data derived from a sample of 80 veterans with PTSD, many of whom were
explicitly requesting "something I can do when I'm stressed, wherever I am." The app
provides 4 primary treatment components: 1) psychoeducation about PTSD, 2) self-monitoring
tools, 3) immediate tools for symptom management, and 4) immediate access to public and
private support resources. The psychoeducation component provides text and audio
informational topics about PTSD, with an emphasis on normalizing the condition, and
information about ways to begin engaging with mental health services. The self-monitoring
tools component administers the PTSD Checklist Civilian version (PCL-C), provides tailored
feedback on symptom level and changes since the last assessment, and allows and encourages
users to create reminders to self-monitor their symptom levels. The symptom management
component provides specific tools tailored for managing reminders of trauma, avoiding
trauma-related triggers, overcoming feelings of being disconnected from others, overcoming
feelings of being disconnected from reality,improving sleep, and reducing feelings of
sadness, hopelessness, worry, anxiety, or anger.These tools include audio-based relaxation
exercises, guided deep breathing, making plans for social activities, engaging in pleasant
activities, tips for distraction from unpleasant sensations, and other simple exercises. The
support component encourages users to create a personal support network (from their phone's
contact list) and provides users with information about additional resources for veterans
(e.g., crisis and help-line numbers). Evidence for PTSD Coach is described in detail in the
Preliminary Studies section. In brief, use of PTSD Coach alone is associated with
significant within-session changes in ratings ofdistress43 and demonstrates a small but
clinically meaningful effect on PTSD symptoms(d=.30, f~.15) relative to a wait-list control
group.

Partners will be provided with a link to the PTSD Family Coach app. PTSD Family Coach
provides four main intervention elements: Learn, Support, Tools for Managing Stress, and
Self-Assessment. The "Learn" section of the app provides extensive, mobile-friendly
information about the basics of PTSD and how to best support their loved one with PTSD, how
to take care of on self while living with someone with PTSD, how to take care of
relationships with children and with one's partner, and how to most effectively encourage
their partner to engage in professional care. The "Support" section of the app provides
information about how to get immediate crisis help (e.g., for medical emergencies, suicidal
thoughts, or threats of violence), how to get help in talking with a partner about PTSD, how
to find family-specific services, resources for parents and children, and resources for the
Veteran. The "Tools for Managing Stress" section of the app contains interactive relaxation
tools, cognitive strategies for managing stress, mindfulness exercises, encouragement to
engage in pleasant activities and to engage in social activities, safety-planning tools,
tips for good sleep hygiene, and grounding techniques. Finally, the "Self-Assessment"
section of the app provides tools for self-monitoring stress symptoms and tracking these
symptoms over time.Description of the Discussion Boards to be used in this study:All
discussion boards will be privately hosted on the secure https://www.health-space.net sight
maintained by the PI and can only be accessed with a unique API key and valid invitation
code stored in the mobile app, so that only those who have been provided with both a
research version of the study app and a valid invitation code will be able to access the
discussion board. There will be 2 unique discussion boards: one for family members (i.e.,
accessed from the PTSD Family Coach app) and one for Veterans (i.e., accessed from the PTSD
Coach app). Those who choose to post a message to the discussion board will be identified
only by their invitation code (a random string of 6 characters and/or digits), and all
messages will be reviewed by the investigators in order to ensure safety and appropriateness
before they can be viewed by any other participants. As soon as a message is posted, an
automated email will be sent to each of the investigators, who will be asked to log-in to a
secure website in order to approve the submitted message so that it can viewed by other
participants. Should any safety or privacy-related concerns arise, or the message is deemed
inappropriate for any other reason, the participant who submitted the message will be
contacted and provided with additional information necessary for either obtaining additional
assistance or modifying the message to make more appropriate or private as necessary.

Every 2 weeks for 8 weeks, each participant will be mailed an information packet (i.e., 4
packets in total for each participant) that will provide additional information on managing
stress and conflict in relationships,increasing positive interactions in the relationship,
problem-solving in relationships, and increasing positive communication in relationships.
Information packets will contain general information, a list of available resources that can
provide additional information, and suggested exercises to practice with their partner or by
using the mobile app.

Ten weeks after being randomized, Veterans and their partners will be asked to complete a
follow-up survey using the Qualtrics web survey tool. Those participants who are willing to
take part in a telephone interview will be contacted by telephone to participate in a
30-minute qualitative interview about the app, communication with their partner about PTSD
symptoms,and suggestions for optimizing partner-based interventions using mobile apps.

Inclusion Criteria:

To be eligible to participate, participants must be either a Veteran with PTSD or living
with a partner who is a Veteran with PTSD.

Veterans must be:

1. A veteran of the U.S. Armed Forces

2. Must have a previous diagnosis of PTSD

3. Must have access to a smart phone using the iOS operating system

4. Must not have previously used PTSD Coach.

Partners of Veterans must be:

1. An intimate partner of a Veteran

2. Living with that partner

3. Must have access to a smart phone using the iOS operating system

4. must be experiencing significant stress

Exclusion Criteria:

a) actual or threatened interpersonal violence in the home