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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03049813
Other study ID # R01MH110524-01
Secondary ID R01MH110524-01
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date July 31, 2022

Study information

Verified date March 2023
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date July 31, 2022
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
United States Thresholds Bridge South Chicago Illinois
United States Thresholds Bridge Southwest Chicago Illinois
United States Thresholds Bridge West Chicago Illinois
United States Thresholds Ogden Chicago Illinois

Sponsors (5)

Lead Sponsor Collaborator
University of Michigan National Institute of Mental Health (NIMH), SIMmersion, LLC, Thresholds Inc., University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Employment Rates Employment rates at 9-month follow-up visit measured with questionnaire. 9 month Follow-Up from Randomization Date
Primary 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. 9 month Follow-Up from Randomization Date
Secondary 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. Pretest (Baseline) and Posttest (approximately 3 months after Baseline)
Secondary 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. Pretest (Baseline) and Posttest (approximately 3 months after Baseline)
Secondary 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. Pretest (Baseline) and Posttest (approximately 3 months after Baseline)
Secondary 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. Pretest (Baseline) and Posttest (approximately 3 months after Baseline)
Secondary 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. Pretest (Baseline) and 6 Month Follow Up from Randomization Date
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