NCT02335528

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
333

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2015

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

5 months

First QC Date

January 7, 2015

Last Update Submit

January 8, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    within 30 days

  • Perceived barriers to care

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

    within 30 days

Secondary Outcomes (1)

  • User experience

    Immediately following their interaction with SimCoach or online form (up to 5 min)

Study Arms (3)

SimCoach intervention

EXPERIMENTAL

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.

Behavioral: SimCoach

Content Matched Control

NO INTERVENTION

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-Treatment Control

NO INTERVENTION

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.

Interventions

SimCoachBEHAVIORAL
SimCoach intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and
  • active duty or Reserve servicemember or National Guard servicemember and
  • being off duty

You may not qualify if:

  • under the age of 18 years
  • retired servicemember or not a servicemember
  • currently on duty
  • currently incarcerated, on parole, or on probation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 9, 2015

Study Start

October 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

January 9, 2015

Record last verified: 2015-01