- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06410794
Virtual Reality Training in Occupational Rehabilitation
Work-related Attention Bias Modification Training and Virtual Reality Training in Occupational Rehabilitation: A Multisite Pilot Study
Work-related attention bias modification training and virtual reality training in occupational rehabilitation is a multisite pilot study.
The quantitative aim of this pilot study is to compared virtual reality (VR) training and attention bias modication (ABM) training to investigate whether the different training forms result in different results measured with work-related outcomes and cognitive outcomes. The qualitative aim of this pilot study is to investigate the patients' experiences with the usage of VR.
Three rehabilitation insitutions will be recruiting patients participating in occupational rehabilitation, and the study will compare the outcomes of work-related interventions with and without the addition of ABM or VR training.
The study seeks to determine if these interventions can improve work ability, reduce symptoms of depression and anxiety, and change attentional bias from negative to positive stimuli.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rauland, Norway, 3864
- Norwegian National Advisory Unit on Occupational Rehabilitation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 - 67 years
- Must be on sick leave, work assessment allowance or on disability pension
- Receiving work-related rehabilitation or treatment at clinics with either an International Classification of Primary Care, Second edition (ICPC-2) within the musculoskeletal (L), psychiatric (P) or unspecific disorders (A) categories or International Classification Disorders-10 diagnosis within the mental and behavioral disorders (F), Diseases of the musculoskeletal system and connective tissue (M) or other diagnoses.
Exclusion Criteria:
- Applying for a full disability pension;
- Unable to complete the measures and receive instructions in Norwegian.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Comparing VR training and ABM training
The objective of this study is to investigate whether VR and ABM training increases work ability, work-related self-efficacy, attention and reduces symptoms of depression and anxiety and consequently change an attentional bias from negative to positive stimuli.
We will compare patients receiving work-related interventions + VR, work-related interventions + ABM training and work-related interventions only.
We will also investigate whether positive changes in attentional bias are associated with increased work participation.
Self-reported work ability, self-efficacy, depression, anxiety and objective computerised cognitive and emotional testing will be assessed at baseline (start rehabilitation/treatment) and at posttest (end rehabilitation/treatment).
|
The VR activity used in the intervention was an add-on activity that did not replace any other activities in the programme.
The off-the-shelf product Beat Saber (Beat Games, Prague, The Czech Republic) is the VR game of choice in our study.
In collaboration with the participating clinics a systematic VR activity plan will be developed.
This includes the selection of games and designing a plan that is interesting and motivating both for patients and clinicians.
|
No Intervention: Patients' experiences with the usage of VR.
The objective of this part is to investigate the experiences in using VR.
R&D personell will make individual interviews with five patients at each of the three clinics involved in piloting VR.
The aim of the interviews will be to capture how the patients experienced the VR activity, the demands of the VR activity, how VR has influenced different aspects of health and whether VR has influenced the abilities to return to work.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increase work ability
Time Frame: Baseline and discharge (four weeks), and 6 and 12 months after discharge
|
Self-reported questionnaire measures, (Work Ability Scale).
Work ability: Self-rated work ability was assessed using a single-item question to determine the WAS; this question was published by Gould et al. as part of the full work ability index (WAI).
The question used by this study to measure WAS ("current work ability compared with your lifetime best") used a scale of 0 to 10 (0 = "completely unable to work" and 10 = "work ability at its best").
The following measurement classification from Gould et al. [46] was used: poor (0 to 5), moderate (6 to 7), good (8 to 9) and excellent (10).
|
Baseline and discharge (four weeks), and 6 and 12 months after discharge
|
Reduced depression and anxiety
Time Frame: Baseline and discharge (four weeks)
|
Self-reported questionnaire measure, (The Hospital Anxiety And Depression Scale).
|
Baseline and discharge (four weeks)
|
Increase expectations to return to work
Time Frame: Baseline and discharge (four weeks), and 6 and 12 months after discharge
|
Self-reported questionnaire measures, (Return-to-Work Expectation)
|
Baseline and discharge (four weeks), and 6 and 12 months after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increased cognitive performance and attention
Time Frame: Baseline and discharge (four weeks)
|
Computerized cognitive measures. - Rapid Visual Information Processing (Cambridge Cognition, 2020). The mean response latency on trials where the subject responded correctly. Calculated across all assessed trials. |
Baseline and discharge (four weeks)
|
Increased cognitive performance and memory
Time Frame: Baseline and discharge (four weeks)
|
Computerized cognitive measures. - Spatial Working Memory (Cambridge Cognition, 2020). The number of times the subject incorrectly revisits a box in which a token has previously been found. |
Baseline and discharge (four weeks)
|
Increased cognitive performance
Time Frame: Baseline and discharge (four weeks)
|
Computerized cognitive measures. - Stop Signal Task (Cambridge Cognition, 2020). The estimate of time when an individual can successfully inhibit their responses 50% of the time. |
Baseline and discharge (four weeks)
|
Patients's experiences in using VR
Time Frame: From discharge up to 5 month after discharge.
|
Interview guide based on the participants experience.
|
From discharge up to 5 month after discharge.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Chris Jensen, PhD, Norwegian National Advisory Unit on Occupational Rehabilitation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 254368
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on Virtual Reality with Beat Saber
-
Escoles Universitaries GimbernatCompleted
-
Istituto Auxologico ItalianoCompletedGeneralized Anxiety DisorderItaly
-
Riphah International UniversityCompleted
-
Vimonwan HiengkaewUnknownStroke | Movement, Abnormal
-
Kırıkkale UniversityCompletedAlzheimer's DementiaTurkey
-
Corporación de Rehabilitación Club de Leones Cruz...Universidad del Rosario; Colombian School of Engineering Julio GaravitoCompleted
-
Federal University of Juiz de ForaCompletedElderly | BalanceBrazil
-
Kutahya Health Sciences UniversityCompletedDental Anxiety | Virtual Reality | Oral SurgeryTurkey
-
Istinye UniversityNot yet recruiting
-
Ohio State UniversityCompletedStress, PhysiologicalUnited States