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Evaluation of a Mobile Phone App for Veterans With PTSD

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ClinicalTrials.gov Identifier: NCT03199742
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Jason Owen, VA Palo Alto Health Care System

Tracking Information
First Submitted Date  ICMJE June 20, 2017
First Posted Date  ICMJE June 27, 2017
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE July 1, 2017
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2017)
  • PTSD Checklist 5 [ Time Frame: 8 weeks ]
    Measures symptoms of post-traumatic stress disorder
  • 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.
  • Engagement with the Application [ Time Frame: 8 weeks ]
    Objectively-measured engagement with the intervention (# sessions)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03199742 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2017)
  • Self-Efficacy for Coping [ Time Frame: 8 weeks ]
    Self-efficacy for managing symptoms of PTSD using an author-constructed outcome measure.
  • Perceived Helpfulness of Intervention [ Time Frame: 8 weeks ]
    How helpful the intervention was for providing information and tools for managing PTSD.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Mobile Phone App for Veterans With PTSD
Official Title  ICMJE Evaluation of a Mobile Phone App for Veterans With PTSD
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Stress Disorders, Post-Traumatic
  • Veterans
Intervention  ICMJE
  • Behavioral: Personalized App Coaching
    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.
  • Behavioral: Active Comparator
    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.
Study Arms  ICMJE
  • Active Comparator: PTSD Coach with no Coaching
    Participants will receive the PTSD coach mobile app.
    Intervention: Behavioral: Active Comparator
  • Experimental: PTSD Coach with Peer Coaching
    Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a Veteran peer.
    Intervention: Behavioral: Personalized App Coaching
  • Experimental: PTSD Coach with Clinician coaching
    Participants will receive the PTSD Coach + mobile app which will provide routine, personalized coaching for 8 weeks from a clinical psychologist.
    Intervention: Behavioral: Personalized App Coaching
  • Experimental: PTSD Coach with Automated Coaching
    Participants will receive the PTSD Coach + mobile app which will provide automated, personalized coaching for 8 weeks.
    Intervention: Behavioral: Personalized App Coaching
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2019)
101
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2017)
600
Actual Study Completion Date  ICMJE March 1, 2019
Actual Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03199742
Other Study ID Numbers  ICMJE IRB-31533
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jason Owen, VA Palo Alto Health Care System
Study Sponsor  ICMJE VA Palo Alto Health Care System
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account VA Palo Alto Health Care System
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP