Schizophrenia Clinical Trial
Official title:
Virtual Reality Job Interview Training: An Enhancement to Supported Employment in Severe Mental Illness
Verified date | March 2023 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Institute of Mental Health (NIMH), SIMmersion, LLC, Thresholds Inc., University of Utah |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |