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OpenTrials
Completed

NCT Number: NCT03199742

Evaluation of a Mobile Phone App for Veterans With PTSD

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.

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Key information

Conditions

Stress Disorders, Post-Traumatic Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders Veterans

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System Menlo Park Division

Menlo Park, California, 94025, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalized App Coaching

Behavioral

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.

Active comparator

Behavioral

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 outcomes

  1. PTSD Checklist 5

    Time frame: 8 weeks

    Measures symptoms of post-traumatic stress disorder

  2. Functional Well-Being

    Time frame: 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.

  3. Engagement with the Application

    Time frame: 8 weeks

    Objectively-measured engagement with the intervention (# sessions)

Secondary outcomes

  1. Self-Efficacy for Coping

    Time frame: 8 weeks

    Self-efficacy for managing symptoms of PTSD using an author-constructed outcome measure.

  2. Perceived Helpfulness of Intervention

    Time frame: 8 weeks

    How helpful the intervention was for providing information and tools for managing PTSD.

Sponsors and collaborators

Lead sponsor

VA Palo Alto Health Care System

Fed

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 27, 2017
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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