- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02335528
SimCoach Evaluation: A Virtual Human Intervention to Encourage Servicemember Help-seeking for PTSD and Depression
January 8, 2015 updated by: RAND
SimCoach, a computer program featuring a virtual human that speaks and gestures in a videogame-like interface, is designed to encourage servicemembers, especially those with signs or symptoms of post-traumatic stress disorder (PTSD) or depression, to seek help to improve their psychological health.
The assessment included a formative component assessing SimCoach's design, development, and implementation approaches, as well as a summative component assessing outcomes among participants in a user experience survey and a randomized controlled trial (RCT).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
333
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age and
- active duty or Reserve servicemember or National Guard servicemember and
- being off duty
Exclusion Criteria:
- under the age of 18 years
- retired servicemember or not a servicemember
- currently on duty
- currently incarcerated, on parole, or on probation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SimCoach intervention
Participants randomized to the SimCoach intervention arm interacted with "Bill Ford," a simulated human (avatar) enacted in the SimCoach program.
This white male avatar representing himself as an Army veteran who spoke to participants in a conversational manner.
Participants interacted with him using a chat interface, where they could type responses to him.
Bill Ford asked participants a series of questions that corresponded to validated PTSD or depression screening questionnaires.
SimCoach then provided personalized recommendations for a symptom if the user reported experiencing the symptom at one of the two highest frequencies on the response scale.
These recommendations consisted of a behavioral recommendation with an accompanying link to a website or online article on the topic.
|
|
|
No Intervention: Content Matched Control
Participants assigned to the Content Matched Control condition arm completed text-based versions of the PCL PTSD screening inventory and PHQ-9 depression screening inventory.
These instruments used standard, validated language and did not use the modified conversational versions used in the SimCoach intervention condition.
The same personalized recommendations provided to the SimCoach group were provided as conventional text and links.
After receiving personalized recommendations, participants completed text versions of primary help-seeking, perceived barriers to seeking help, and secondary outcome (user experience) measures.
|
|
|
No Intervention: No-Treatment Control
Participants randomized to the No-Treatment Control arm completed measures of the primary outcome (intentions to seek help) prior to being given a choice of SimCoach or the conventional screening administered in the other two arms of the study.
After the help-seeking intention questionnaire was administered, participants were told that they would be asked some questions about any PTSD or depression symptoms that they might be having and were given the choice between chatting online with a virtual human or using an online form (options were presented in random order to prevent any influence of ordering on selection of the tool).
After either interacting with SimCoach or filling out an online form, participants completed a questionnaire assessing user experience.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Help-seeking intentions
Time Frame: within 30 days
|
Participants were asked the following question: "How likely is it that you will seek help for issues such as stress, emotional, alcohol, drug, or family problems from the following people in the next month?"
and responded using a Likert scale ranging from 1=extremely unlikely to 7=extremely likely.
|
within 30 days
|
|
Perceived barriers to care
Time Frame: within 30 days
|
Subjects were asked about their perceptions of both stigma-related and practical barriers to seeking help.
|
within 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
User experience
Time Frame: Immediately following their interaction with SimCoach or online form (up to 5 min)
|
Participants responded to questions about their experience with the tool or the online form.
|
Immediately following their interaction with SimCoach or online form (up to 5 min)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
January 7, 2015
First Submitted That Met QC Criteria
January 8, 2015
First Posted (Estimate)
January 9, 2015
Study Record Updates
Last Update Posted (Estimate)
January 9, 2015
Last Update Submitted That Met QC Criteria
January 8, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-504 W74V8H-06-C-0002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.