Back to resultsVirtual Reality Job Interview Training in Severe Mental Illness
Primary Purpose
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Job Interview Training
Supported Employment (Services as Usual)
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Over the age of 18
Diagnosis of any of the following:
- 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;
- 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;
- Any depressive disorder, including disruptive mood dysregulation disorder, major depressive disorder, persistent depressive disorder, other specified depressive disorder, and unspecified depressive disorder;
- Posttraumatic stress disorder
- fluency in English
- 6th grade reading level
- Enrolled in Supported Employment/Individual Placement Support (IPS)
- Active IPS enrollee as indicated by at least 1 contact with his/her Employment Specialist in the past 30 days.
- Currently unemployed or underemployed
- 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.
Sites / Locations
- Thresholds Bridge South
- Thresholds Ogden
- Thresholds Bridge Southwest
- Thresholds Bridge West
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Virtual Reality Job Interview Training
Supported Employment (Services as Usual)
Arm Description
Virtual Reality Job Interview Training
Supported Employment (Services as Usual)
Outcomes
Primary Outcome Measures
Employment Rates
Employment rates at 9-month follow-up visit measured with questionnaire.
Time to Employment
We evaluated the number of days between randomization and obtaining employment using a questionnaire administered over phone interviews with the subject and also verifying with Supported Employment (IPS) tracking system.
Secondary Outcome Measures
Job Interview Skills
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. An average of the two scenarios at baseline was used to create a single pretest score and an average of the two scenarios at posttest was used to create a single posttest score. The method of assessment is the job interview skills rating scale as measured by the Mock Interview Rating Scale. Possible scores range from 8 to 40, with higher scores indicating better interview skills.
Interview Self-Confidence
Self-reported interview self-confidence. Participants self-reported their confidence in interview skills at pretest and posttest by using a nine-item survey, with items rated on a 7-point scale (1, extremely unskilled, to 7, extremely skilled); total scores were computed across all items. The minimum score is 9 and the maximum score would be 63. Higher scores indicate higher self-confidence in interview skills.
Interview Anxiety
Self-reported measure of interviewing anxiety completed at pretest and posttest. Participants rated their interview anxiety with an adapted version of the 34-item Personal Report of Public Speaking Apprehension (PRSPA); the phrase "publics peaking" was replaced with "job interviewing." Items were coded from 1, strongly disagree, to 5, strongly agree. Total scores were computed by using the PRSPA's validated two-step total score procedure with the minimum score being 34 and maximum score being 170. Higher scores indicate higher interview anxiety.
Social Competence
Measured by Social Skills Performance Assessment (SSPA). Roleplay performance: The SSPA includes two brief (3-minute) roleplays in which participants engage in a conversation with an unknown confederate who plays the role of a new neighbor(NN) or a landlord (LL). The NN and LL role plays were video recorded at the pre- and posttest visits and were blindly rated by use of an anchoring system. The NN roleplay was scored on eight items via a 5-point scale (e.g., 5,very interested, to 1, very disinterested), and the LL roleplay was scored on nine items via a 5-point scale (e.g., 5,very focused, to 1, very unfocused). The two role-play scores were combined to create one total pretest score and one total posttest score. Sum scores could have a minimum of 17 and maximum of 85. Higher scores indicated better skills.
Psychological Distress - Brief Psychiatric Rating Scale
The Brief Psychiatric Rating Scale (BPRS) consists of 18 items and uses a seven-item Likert scale with 1 = "not present", and 7 = "extremely severe". Sum scores can range from 18 to 126. Higher scores indicate more symptoms.
Full Information
NCT ID
NCT03049813
First Posted
February 8, 2017
Last Updated
March 7, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH), Thresholds Inc., SIMmersion, LLC, University of Utah
1. Study Identification
Unique Protocol Identification Number
NCT03049813
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH), Thresholds Inc., SIMmersion, LLC, University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Depressive Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Some, but not all, outcomes require masking for the assessor.
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Job Interview Training
Arm Type
Experimental
Arm Description
Virtual Reality Job Interview Training
Arm Title
Supported Employment (Services as Usual)
Arm Type
Other
Arm Description
Supported Employment (Services as Usual)
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Job Interview Training
Intervention Description
Job interview training using virtual reality software created by SIMmersion, Inc, in addition to standard supported employment services.
Intervention Type
Other
Intervention Name(s)
Supported Employment (Services as Usual)
Intervention Description
Standard supported employment services.
Primary Outcome Measure Information:
Title
Employment Rates
Description
Employment rates at 9-month follow-up visit measured with questionnaire.
Time Frame
9 month Follow-Up from Randomization Date
Title
Time to Employment
Description
We evaluated the number of days between randomization and obtaining employment using a questionnaire administered over phone interviews with the subject and also verifying with Supported Employment (IPS) tracking system.
Time Frame
9 month Follow-Up from Randomization Date
Secondary Outcome Measure Information:
Title
Job Interview Skills
Description
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. An average of the two scenarios at baseline was used to create a single pretest score and an average of the two scenarios at posttest was used to create a single posttest score. The method of assessment is the job interview skills rating scale as measured by the Mock Interview Rating Scale. Possible scores range from 8 to 40, with higher scores indicating better interview skills.
Time Frame
Pretest (Baseline) and Posttest (approximately 3 months after Baseline)
Title
Interview Self-Confidence
Description
Self-reported interview self-confidence. Participants self-reported their confidence in interview skills at pretest and posttest by using a nine-item survey, with items rated on a 7-point scale (1, extremely unskilled, to 7, extremely skilled); total scores were computed across all items. The minimum score is 9 and the maximum score would be 63. Higher scores indicate higher self-confidence in interview skills.
Time Frame
Pretest (Baseline) and Posttest (approximately 3 months after Baseline)
Title
Interview Anxiety
Description
Self-reported measure of interviewing anxiety completed at pretest and posttest. Participants rated their interview anxiety with an adapted version of the 34-item Personal Report of Public Speaking Apprehension (PRSPA); the phrase "publics peaking" was replaced with "job interviewing." Items were coded from 1, strongly disagree, to 5, strongly agree. Total scores were computed by using the PRSPA's validated two-step total score procedure with the minimum score being 34 and maximum score being 170. Higher scores indicate higher interview anxiety.
Time Frame
Pretest (Baseline) and Posttest (approximately 3 months after Baseline)
Title
Social Competence
Description
Measured by Social Skills Performance Assessment (SSPA). Roleplay performance: The SSPA includes two brief (3-minute) roleplays in which participants engage in a conversation with an unknown confederate who plays the role of a new neighbor(NN) or a landlord (LL). The NN and LL role plays were video recorded at the pre- and posttest visits and were blindly rated by use of an anchoring system. The NN roleplay was scored on eight items via a 5-point scale (e.g., 5,very interested, to 1, very disinterested), and the LL roleplay was scored on nine items via a 5-point scale (e.g., 5,very focused, to 1, very unfocused). The two role-play scores were combined to create one total pretest score and one total posttest score. Sum scores could have a minimum of 17 and maximum of 85. Higher scores indicated better skills.
Time Frame
Pretest (Baseline) and Posttest (approximately 3 months after Baseline)
Title
Psychological Distress - Brief Psychiatric Rating Scale
Description
The Brief Psychiatric Rating Scale (BPRS) consists of 18 items and uses a seven-item Likert scale with 1 = "not present", and 7 = "extremely severe". Sum scores can range from 18 to 126. Higher scores indicate more symptoms.
Time Frame
Pretest (Baseline) and 6 Month Follow Up from Randomization Date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over the age of 18
Diagnosis of any of the following:
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;
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;
Any depressive disorder, including disruptive mood dysregulation disorder, major depressive disorder, persistent depressive disorder, other specified depressive disorder, and unspecified depressive disorder;
Posttraumatic stress disorder
fluency in English
6th grade reading level
Enrolled in Supported Employment/Individual Placement Support (IPS)
Active IPS enrollee as indicated by at least 1 contact with his/her Employment Specialist in the past 30 days.
Currently unemployed or underemployed
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J Smith, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thresholds Bridge South
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60609
Country
United States
Facility Name
Thresholds Ogden
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
Facility Name
Thresholds Bridge Southwest
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60632
Country
United States
Facility Name
Thresholds Bridge West
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60644
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Virtual Reality Job Interview Training in Severe Mental Illness
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