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PTSD Training for PCPs in a Virtual World (VW)

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ClinicalTrials.gov Identifier: NCT03898271
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Karen Seal, San Francisco Veterans Affairs Medical Center

Brief Summary:

The overall goal of this project is improve access to and engagement in quality care for military service personnel and Veterans suffering with posttraumatic stress (PTS). Veterans often present to their primary care providers with symptoms of PTS and related physical problems; however, most primary care providers have not been trained to care for Veterans with PTS or communicate with them in ways that motivate them to engage in care.

In this study instigators propose to design, test and prepare to implement a Virtual World PTS and Motivational Interviewing training for primary care providers by taking the following steps: (1) partner with stakeholders to iteratively design the training which takes full advantage of the affordances of Virtual World technology to enhance training interactivity, effectiveness, and durability, (2) perform a randomized control trial to compare the virtual world training with an online training, and (3) summarize the findings and prepare for implementation and dissemination of the new training by soliciting feedback from primary care providers who participated in the training and from original project stakeholders.


Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Other: Virtual World Not Applicable

Detailed Description:

The overall goal of this project is improve access to and engagement in quality care for military service personnel and Veterans suffering with posttraumatic stress (PTS). Veterans who have PTS symptoms after military service are often resistant to referrals to mental health care because of the warrior culture of stoicism coupled with the stigma of seeking mental health care. Also, Veterans living in rural or remote areas may not have access to trained mental health professionals. Thus, Veterans often present to their primary care providers with symptoms of PTS and related physical problems. Unfortunately, most primary care providers have not been trained to care for Veterans with PTS or communicate with them in ways that motivate them to engage in care. This can result in missed opportunities to intervene to prevent what may become chronic mental and physical health problems in the future, which affect not only the warfighter, but also their families, partners and children.

In a prior project funded by the Department of Defense (DoD), study investigators created and tested a web-based training program to teach primary care providers about how to assess for and manage PTS which proved successful in a small pilot study. Nevertheless, primary care providers who participated in the training reported that the training was not interactive and engaging enough and about 30% did not complete it. Moreover, the pilot study did not use gold standard methods to measure study outcomes and because project stakeholders, namely the Veterans Administration (VA) and the DoD, did not participate in the development of the training, investigators were not able to easily implement and disseminate it to primary care clinicians who work in these healthcare systems.

Virtual World technology is a three-dimensional immersive and highly interactive online experience in which users enter virtual environments as self-styled representations of themselves, known as avatars. Virtual Worlds are used in some of the most popular and engaging commercially-available video games. Virtual World technology is also increasingly being used for educational activities, particularly in learning about mental health problems and communication techniques. This is because experiences like mental health symptoms such as re-experiencing or intrusive thoughts (flashbacks) can be simulated, and participants (as avatars) can practice and receive feedback on new communication skills without feeling self-conscious. Learners can also practice motivational interviewing techniques such as using a stylized virtual scale to literally weigh the pros and cons (represented as blocks) of a particular behavior change. These interactive activities afforded by Virtual World technology can be used to make the learning experience far more memorable and enduring.

In this study, investigators propose to design, test and prepare to implement a Virtual World PTS and Motivational Interviewing training by taking the following steps: (1) partner with stakeholders to iteratively design the training so that is responsive to stakeholder needs and takes full advantage of the affordances of Virtual World technology to enhance training interactivity, effectiveness, and durability, (2) add a more robust evaluation component, including a randomized control trial with stronger provider and patient outcomes to achieve more valid results, and (3) summarize findings and prepare for implementation and dissemination of the new training by soliciting feedback from primary care providers who participated in the training and from original project stakeholders.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Improving Access to Care for Warfighters: Virtual Worlds Technology to Enhance Primary Care Training in Posttraumatic Stress and Motivational Interviewing
Actual Study Start Date : October 1, 2015
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Virtual World Training
Synchronous PTSD training in a virtual world environment
Other: Virtual World
Participants will complete a synchronous PTSD training in an immersive virtual world environment.

Active Comparator: Web-based Video Training
Asynchronous web-based PTSD training
Other: Virtual World
Participants will complete a synchronous PTSD training in an immersive virtual world environment.




Primary Outcome Measures :
  1. Motivational Interviewing Treatment Integrity (MITI) Scale [ Time Frame: 3 months ]
    Use standardized patient interviews to observe change in Motivational Interviewing (MI) skills to assess and manage PTSD symptoms and to motivate engagement in care.

  2. PTSD Symptom Assessment and Management Scale [ Time Frame: 3 months ]
    Use standardized patient interviews to observe change in PTSD assessment and management clinical skills.


Secondary Outcome Measures :
  1. Evaluation of PTSD Knowledge Questionnaire [ Time Frame: 3 months ]
    Use self-reported measures to observe change in PTSD related knowledge and change in self-reported use of PTSD knowledge after 90 days of no contact.

  2. Self-Efficacy Around PTSD Questionnaire [ Time Frame: 3 months ]
    Use self-reported measures to observe change in PTSD self-efficacy and change in self-reported PTSD self-efficacy after 90 days of no contact.

  3. Provider Satisfaction with Training Questionnaire [ Time Frame: 3 months ]
    Use self-reported measures to compare provider satisfaction with training in the virtual world training vs. the online video training



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary Care Providers (PCPs) currently practicing adult medicine (including licensed internists, family practitioners, nurse practitioners, physician assistants, allied health professionals and trainees working in Primary Care setting)
  • English-speaking

Exclusion Criteria:

  • Lack of sufficient time to participate in all required training sessions, homework and evaluations.
  • Lack of a computer capable of running the Virtual World software
  • Retired or retiring during the study period
  • Vision or hearing impaired or other disability precluding the use of a computer or telephone*

    • While this is an exclusionary criterion for this trial, prior to broader dissemination, at the conclusion of the study, we will make accommodations in the Virtual World training to make it Section 508-compliant for persons with disabilities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898271


Contacts
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Contact: Coleen Hill, BA 415-933-9480 coleen.hill@va.gov
Contact: Nicole McCamish, MA 415-676-1547 nicole.mccamish@va.gov

Locations
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United States, California
San Francisco VA Health Care System Recruiting
San Francisco, California, United States, 94121
Contact: Coleen Hill, BA    415-933-9480    coleen.hill@va.gov   
Contact: Nicole McCamish, MA    415-676-1457      
Principal Investigator: Karen H Seal, MD, MPH         
Sponsors and Collaborators
San Francisco Veterans Affairs Medical Center
United States Department of Defense

Additional Information:
Publications:
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Responsible Party: Karen Seal, Principal Investigator, San Francisco Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03898271     History of Changes
Other Study ID Numbers: 14-15004
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karen Seal, San Francisco Veterans Affairs Medical Center:
PTSD
Motivational Interviewing
veterans
military
virtual world
virtual reality
education
training
primary care
mental health
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders