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SchizophreniaNCT03049813

Virtual Reality Job Interview Training in Severe Mental Illness

A study testing Virtual Reality Job Interview Training and Supported Employment (Services as Usual) in people with Schizophrenia and Schizoaffective Disorder, run by University of Michigan at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Virtual Reality Job Interview Training and Supported Employment (Services as Usual)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
4 sitesUnited States
Study dates
1 Jun 2017to 31 Jul 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Thresholds Bridge South

    Chicago, Illinois, 60609

  • Thresholds Ogden

    Chicago, Illinois, 60613

  • Thresholds Bridge Southwest

    Chicago, Illinois, 60632

  • Thresholds Bridge West

    Chicago, Illinois, 60644

Other trials in United States

About this study

Official title: Virtual Reality Job Interview Training: An Enhancement to Supported Employment in Severe Mental Illness

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.

Being tested
Virtual Reality Job Interview Training, Supported Employment (Services as Usual)
Medical subject headings
Schizophrenia, Psychotic Disorders, Bipolar Disorder, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality Job Interview TrainingBehavioural

    Job interview training using virtual reality software created by SIMmersion, Inc, in addition to standard supported employment services.

  • Supported Employment (Services as Usual)Other

    Standard supported employment services.

Study groups in NCT03049813
Study groupRoleWhat they receive
Virtual Reality Job Interview TrainingExperimentalVirtual Reality Job Interview Training
Receives: Behavioral: Virtual Reality Job Interview Training
Supported Employment (Services as Usual)OtherSupported Employment (Services as Usual)
Receives: Other: Supported Employment (Services as Usual)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Employment Rates

    Employment rates at 9-month follow-up visit measured with questionnaire.

    Measured: 9 month Follow-Up from Randomization Date

  2. 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.

    Measured: 9 month Follow-Up from Randomization Date

Secondary outcomes (5)

  1. 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.

    Measured: Pretest (Baseline) and Posttest (approximately 3 months after Baseline)

  2. 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.

    Measured: Pretest (Baseline) and Posttest (approximately 3 months after Baseline)

  3. 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.

    Measured: Pretest (Baseline) and Posttest (approximately 3 months after Baseline)

  4. 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.

    Measured: Pretest (Baseline) and Posttest (approximately 3 months after Baseline)

  5. 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.

    Measured: Pretest (Baseline) and 6 Month Follow Up from Randomization Date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2017
  2. Study start1 Jun 2017
  3. Primary completion30 Jun 2021
  4. Study completion31 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03049813
Sponsor's protocol ID
R01MH110524-01
Other IDs
R01MH110524-01
Status last verified
Mar 2023
First submitted
8 Feb 2017
Last updated
9 Mar 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Smith MJ, Burke-Miller JK, Bornheimer LA, Ross B, Bell MD, McGurk SR, Mueser KT, Brown A, Prestipino J, Borghani N, Nelson K, Lieberman T, Pashka NJ, Razzano LA, Kallen MA. Psychometric properties of the mock interview rating scale for schizophrenia and other serious mental illnesses. Front Psychiatry. 2023 Apr 27;14:1150307. doi: 10.3389/fpsyt.2023.1150307. eCollection 2023.

    PubMed 37181877

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Job Interview Training and Supported Employment (Services as Usual) in people with Schizophrenia and Schizoaffective Disorder, run by University of Michigan at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Employment Rates (time frame: 9 month Follow-Up from Randomization Date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03049813, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.

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