Clinical trial NCT03049813: Virtual Reality Job Interview Training in Severe Mental Illness
Official title: Virtual Reality Job Interview Training: An Enhancement to Supported Employment in Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Depressive Disorder
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Thresholds Inc.
name: SIMmersion, LLC
name: University of Utah
First posted: 2017-02-10
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

1. Over the age of 18
2. Diagnosis of any of the following:

   1. Any chronic schizophrenia spectrum disorder, including schizophrenia, schizoaffective disorder, delusional disorder, brief psychotic disorder, schizophreniform disorder, other specified schizophrenia spectrum and related disorder, and unspecified schizophrenia spectrum and related disorders;
   2. Any bipolar spectrum disorder beyond bipolar type I and II to include cyclothymia, other specified bipolar and related disorder, and unspecified bipolar and related disorders;
   3. Any depressive disorder, including disruptive mood dysregulation disorder, major depressive disorder, persistent depressive disorder, other specified depressive disorder, and unspecified depressive disorder;
   4. Posttraumatic stress disorder
3. fluency in English
4. 6th grade reading level
5. Enrolled in Supported Employment/Individual Placement Support (IPS)
6. Active IPS enrollee as indicated by at least 1 contact with his/her Employment Specialist in the past 30 days.
7. Currently unemployed or underemployed
8. Planning to go on interviews within 4 weeks of registration on study.
9. Willing to be video recorded for certain study elements.
10. Must have given signed, informed consent prior to registration on study.

Exclusion Criteria:

1. Documented developmental or learning disability.
2. Medical condition that may compromise cognition (e.g., Parkinson's Disease, Alzheimer's Disease, Huntington's Chorea, Moderate or Greater TBI).
3. Uncorrected vision or hearing problems
4. 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)
5. 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.

Primary outcomes:
measure: Employment Rates
timeFrame: 9 month Follow-Up from Randomization Date
measure: Time to Employment
timeFrame: 9 month Follow-Up from Randomization Date
Secondary outcomes:
measure: Job Interview Skills
timeFrame: Pretest (Baseline) and Posttest (approximately 3 months after Baseline)
measure: Interview Self-Confidence
timeFrame: Pretest (Baseline) and Posttest (approximately 3 months after Baseline)
measure: Interview Anxiety
timeFrame: Pretest (Baseline) and Posttest (approximately 3 months after Baseline)
measure: Social Competence
timeFrame: Pretest (Baseline) and Posttest (approximately 3 months after Baseline)
measure: Psychological Distress - Brief Psychiatric Rating Scale
timeFrame: Pretest (Baseline) and 6 Month Follow Up from Randomization Date
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Thresholds Bridge South
state: Illinois
city: Chicago
country: United States
facility: Thresholds Ogden
state: Illinois
city: Chicago
country: United States
facility: Thresholds Bridge Southwest
state: Illinois
city: Chicago
country: United States
facility: Thresholds Bridge West
state: Illinois
Study officials:
affiliation: Northwestern University
name: Matthew J Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: