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Virtual Reality Job Interview Training in Severe Mental Illness

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ClinicalTrials.gov Identifier: NCT03049813
Recruitment Status : Recruiting
First Posted : February 10, 2017
Last Update Posted : June 5, 2017
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Thresholds Inc.
SIMmersion, LLC
Information provided by (Responsible Party):
Matthew Smith, University of Michigan

Brief Summary:
This is a randomized controlled trial to evaluate the community-based effectiveness of virtual reality job interview training (VR-JIT). Northwestern University is partnering with Thresholds Inc. to evaluate the effectiveness of VR-JIT at improving interviewing skills and access to employment. In addition, we will evaluate the cost effectiveness of VR-JIT and the process for implementing VR-JIT at Thresholds.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Bipolar Disorder Depressive Disorder Behavioral: Virtual Reality Job Interview Training Other: Supported Employment (Services as Usual) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Some, but not all, outcomes require masking for the assessor.
Primary Purpose: Other
Official Title: Virtual Reality Job Interview Training: An Enhancement to Supported Employment in Severe Mental Illness
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Virtual Reality Job Interview Training
Virtual Reality Job Interview Training
Behavioral: Virtual Reality Job Interview Training
Job interview training using virtual reality software created by SIMmersion, Inc, in addition to standard supported employment services.
Supported Employment (Services as Usual)
Supported Employment (Services as Usual)
Other: Supported Employment (Services as Usual)
Standard supported employment services.



Primary Outcome Measures :
  1. Employment rates [ Time Frame: 6 months ]
    Employment rates at 6-month follow-up visit measured with questionnaire.


Other Outcome Measures:
  1. Job interview skills [ Time Frame: 6 months ]
    Interviewing skills will be measured using a role-play measure in which subjects act out two job interview scenarios with trained actors. Interviews will be video recorded and scored. The method of assessment is the job interview skills rating scale.

  2. Time to employment [ Time Frame: 6 months ]
    We will evaluate the number of weeks between the completion of the training and obtaining employment using a questionnaire administered over phone interviews with the subject.

  3. Psychological distress [ Time Frame: 6 months ]
    This measures will be assessed using the Brief Psychiatric Rating Scale (administered by research staff) and Beck Depression Inventory (subject self-report measure).



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Within the age range of 18-55
  • Diagnosis of Bipolar Disorder or Major Depressive Disorder (with or without psychotic features), or Schizophrenia or Schizoaffective Disorder
  • fluency in English
  • 6th grade reading level
  • Enrolled in IPS within the past 4 months.
  • Active IPS enrollee as indicated by at least 2 contacts with his/her Employment Specialist in the past 30 days.
  • Currently unemployed.
  • Planning to go on interviews within 4 weeks of registration on study.
  • Willing to be video recorded for certain study elements.
  • Must have given signed, informed consent prior to registration on study.

Exclusion Criteria:

  • Documented developmental or learning disability.
  • Medical condition that may compromise cognition (e.g., Parkinson's Disease, Alzheimer's Disease, Huntington's Chorea, Moderate or Greater TBI).
  • Uncorrected vision or hearing problems
  • Active suicidal ideation within the last 30 days with at least some intent to act, with or without a specific plan; this would be reflected in a score of 4 or 5 on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (CSSRS)
  • A past suicide attempt within the past 30 days that did not include preparatory acts or behavior, but was defined by a potentially self-injurious act committed with at least some wish to die as a result of the act.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049813


Contacts
Contact: Rachel Sax, MA 3125031371 rachel.sax@northwestern.edu

Locations
United States, Illinois
Thresholds Bridge South Recruiting
Chicago, Illinois, United States, 60609
Contact: Nicole Pashka    773-572-5265    Nicole.Pashka@thresholds.org   
Thresholds Ogden Recruiting
Chicago, Illinois, United States, 60613
Contact: Nicole Pashka    773-572-5265    Nicole.pashka@thresholds.org   
Thresholds Bridge Southwest Recruiting
Chicago, Illinois, United States, 60632
Contact: Nicole Pashka    773-572-5265    Nicole.Pashka@thresholds.org   
Thresholds Bridge West Recruiting
Chicago, Illinois, United States, 60644
Contact: Nicole Pashka    773-572-5265    Nicole.Pashka@thresholds.org   
Sponsors and Collaborators
Northwestern University
National Institute of Mental Health (NIMH)
Thresholds Inc.
SIMmersion, LLC
Investigators
Principal Investigator: Matthew J Smith, PhD Northwestern University

Responsible Party: Matthew Smith, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03049813     History of Changes
Other Study ID Numbers: R01MH110524-01 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Schizophrenia
Depressive Disorder
Depression
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mood Disorders
Behavioral Symptoms
Bipolar and Related Disorders