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SimCoach Evaluation: A Virtual Human Intervention to Encourage Servicemember Help-seeking for PTSD and Depression

Primary Purpose

Post-traumatic Stress Disorder, Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SimCoach
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    No Intervention

    No Intervention

    Arm Label

    SimCoach intervention

    Content Matched Control

    No-Treatment Control

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Help-seeking intentions
    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.
    Perceived barriers to care
    Subjects were asked about their perceptions of both stigma-related and practical barriers to seeking help.

    Secondary Outcome Measures

    User experience
    Participants responded to questions about their experience with the tool or the online form.

    Full Information

    First Posted
    January 7, 2015
    Last Updated
    January 8, 2015
    Sponsor
    RAND
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02335528
    Brief Title
    SimCoach Evaluation: A Virtual Human Intervention to Encourage Servicemember Help-seeking for PTSD and Depression
    Official Title
    SimCoach Evaluation: A Virtual Human Intervention to Encourage Servicemember Help-seeking for PTSD and Depression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    March 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    RAND

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-traumatic Stress Disorder, Depression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    333 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SimCoach intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Content Matched Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    No-Treatment Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    SimCoach
    Primary Outcome Measure Information:
    Title
    Help-seeking intentions
    Description
    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.
    Time Frame
    within 30 days
    Title
    Perceived barriers to care
    Description
    Subjects were asked about their perceptions of both stigma-related and practical barriers to seeking help.
    Time Frame
    within 30 days
    Secondary Outcome Measure Information:
    Title
    User experience
    Description
    Participants responded to questions about their experience with the tool or the online form.
    Time Frame
    Immediately following their interaction with SimCoach or online form (up to 5 min)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    SimCoach Evaluation: A Virtual Human Intervention to Encourage Servicemember Help-seeking for PTSD and Depression

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