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

NCT ID: NCT02335528

Last Updated: 2015-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 333 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-03-31

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).

Conditions

Post-traumatic Stress Disorder; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SimCoach

Intervention Type: BEHAVIORAL

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SimCoach

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RAND

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

10-504 W74V8H-06-C-0002

Identifier Type: -

Identifier Source: org_study_id

NCT03103165

Identifier Type: -

Identifier Source: nct_alias