Use of Mobile Apps for Those With PTSD and Their Partners
Condition: Ptsd
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      In layperson's language state the purpose of the study in 3-5 sentences.

      Previous research has demonstrated that intimate partners can positively influence those with
      PTSD to seek treatment. The investigators have preliminary evidence to demonstrate that
      mobile apps, such as PTSD Coach can be helpful for those with PTSD, and the current study
      will provide Veterans with PTSD and their partners with a mobile app designed to promote
      engagement with evidence-based treatments for PTSD. The purpose of this PILOT study is to
      evaluate methods for delivering a couples-based intervention to reduce PTSD symptoms and
      improve relationship quality in Veterans and their intimate partners.

      b) State what the Investigator(s) hope to learn from the study. Include an assessment of the
      importance of this new knowledge.

      Understanding ways to improve the public health impact of public-facing, evidence-based
      mobile apps is critical. This study will test a low-cost, "high-touch" approach to improving
      the outcomes associated with use of the PTSD Coach and PTSD Family Coach mobile apps,which
      are already available to the general public and used by over 55,000 new users per year.This
      study will test whether the involvement of an intimate partner in the use of a mobile app for
      PTSD will result in changes in how the mobile apps are used and in relationship quality and
      PTSD symptoms over time. Additionally, this study will test whether the addition of a
      discussion board can improve engagement with the apps and/or outcomes. The study will also
      provide useful qualitative data that can inform the development of subsequent dyadic
      interventions using mobile technologies.

      c) Explain why human subjects must be used for this project. (i.e. purpose of study is to
      test efficacy of investigational device in individuals with specific condition; purpose of
      study is to examine specific behavioral traits in humans in classroom or other environment)

      The purpose of this study is to evaluate how Veterans and their partners interact with
      evidence-based mobile apps for improving PTSD symptoms.
    

Detailed description: 
      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.
    

Intervention name(s): Mobile App + Mailed Materials for managing stress associated with PTSD; Mobile App for managing stress associated with PTSD
Intervention type(s): Behavioral; Behavioral
Intervention description(s): PTSD Coach and PTSD Family Coach mobile apps plus mailed "Couples Coach" intervention materials and discussion board added to PTSD Family Coach app; PTSD Coach and PTSD Family Coach mobile apps
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: family, caregiving, ptsd, couples