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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03898271
Other study ID # 14-15004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2015

Study information

Verified date October 2020
Source San Francisco Veterans Affairs Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date
Est. primary completion date September 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

Other:
Virtual World
Participants will complete a synchronous PTSD training in an immersive virtual world environment.

Locations

Country Name City State
United States San Francisco VA Health Care System San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
San Francisco Veterans Affairs Medical Center United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (1)

Samuelson KW, Koenig CJ, McCamish N, Choucroun G, Tarasovsky G, Bertenthal D, Seal KH. Web-based PTSD training for primary care providers: a pilot study. Psychol Serv. 2014 May;11(2):153-61. doi: 10.1037/a0034855. Epub 2013 Dec 23. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Motivational Interviewing Treatment Integrity (MITI) Scale Use standardized patient interviews to observe change in Motivational Interviewing (MI) skills to assess and manage PTSD symptoms and to motivate engagement in care. 3 months
Primary PTSD Symptom Assessment and Management Scale Use standardized patient interviews to observe change in PTSD assessment and management clinical skills. 3 months
Secondary Evaluation of PTSD Knowledge Questionnaire 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. 3 months
Secondary Self-Efficacy Around PTSD Questionnaire 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 months
Secondary Provider Satisfaction with Training Questionnaire Use self-reported measures to compare provider satisfaction with training in the virtual world training vs. the online video training 3 months
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