Post Traumatic Stress DisorderVWNCT03898271
PTSD Training for PCPs in a Virtual World
A study testing Virtual World in people with Post Traumatic Stress Disorder, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Virtual World
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2015to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Health Care System
San Francisco, California, 94121
About this study
Official title: Improving Access to Care for Warfighters: Virtual Worlds Technology to Enhance Primary Care Training in Posttraumatic Stress and Motivational Interviewing
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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Virtual World
- Keywords
- PTSD, Motivational Interviewing, veterans, military, virtual world, virtual reality, education, training, primary care, mental health
- Medical subject headings
- Stress Disorders, Post-Traumatic, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual WorldOther
Participants will complete a synchronous PTSD training in an immersive virtual world environment.
| Study group | Role | What they receive |
|---|---|---|
| Virtual World Training | Experimental | Synchronous PTSD training in a virtual world environment Receives: Other: Virtual World |
| Web-based Video Training | Active comparator | Asynchronous web-based PTSD training Receives: Other: Virtual World |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
PTSD Symptom Assessment and Management Scale
Use standardized patient interviews to observe change in PTSD assessment and management clinical skills.
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 3 months
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.
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 Oct 2015
- Primary completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Francisco Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Karen Seal, San Francisco Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898271
- Sponsor's protocol ID
- 14-15004
- Acronym
- VW
- Status last verified
- Oct 2020
- First submitted
- 27 Mar 2019
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24364595Manuel JK, Purcell N, Abadjian L, Cardoos S, Yalch M, Hill C, McCarthy B, Bertenthal D, McGrath S, Seal K. Virtual Worlds Technology to Enhance Training for Primary Care Providers in Assessment and Management of Posttraumatic Stress Disorder Using Motivational Interviewing: Pilot Randomized Controlled Trial. JMIR Med Educ. 2023 Aug 28;9:e42862. doi: 10.2196/42862.
PubMed 37639299
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access to Care for Warfighters: Virtual Worlds Technology to Enhance Primary Care Training in Posttraumatic Stress and Motivational Interviewing
- ClinicalTrials.gov ID
- NCT03898271
- Acronym / sponsor ID
- VW / 14-15004
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD, Motivational Interviewing, veterans, military, virtual world, virtual reality, education, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- San Francisco Veterans Affairs Medical CenterUS federal agency
- Collaborators
- United States Department of Defense
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual World Training | Experimental | Other: Virtual WorldSynchronous PTSD training in a virtual world environment |
| Web-based Video Training | Active comparator | Other: Virtual WorldAsynchronous web-based PTSD training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual WorldParticipants will complete a synchronous PTSD training in an immersive virtual world environment. | Other | Virtual World Training, Web-based Video Training |
Primary outcome
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.
PTSD Symptom Assessment and Management Scale
Time frame: 3 months
Use standardized patient interviews to observe change in PTSD assessment and management clinical skills.
3 secondary outcomes
Evaluation of PTSD Knowledge Questionnaire
Time frame: 3 months
Self-Efficacy Around PTSD Questionnaire
Time frame: 3 months
Provider Satisfaction with Training Questionnaire
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Background: PubMed 24364595Samuelson 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.
- Derived from this study: PubMed 37639299Manuel JK, Purcell N, Abadjian L, Cardoos S, Yalch M, Hill C, McCarthy B, Bertenthal D, McGrath S, Seal K. Virtual Worlds Technology to Enhance Training for Primary Care Providers in Assessment and Management of Posttraumatic Stress Disorder Using Motivational Interviewing: Pilot Randomized Controlled Trial. JMIR Med Educ. 2023 Aug 28;9:e42862. doi: 10.2196/42862.
- Veterans Return HomeLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual World in people with Post Traumatic Stress Disorder, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motivational Interviewing Treatment Integrity (MITI) Scale (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03898271, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.