Musculoskeletal DiseasesNCT06410794
Virtual Reality Training in Occupational Rehabilitation
A study testing Virtual Reality with Beat Saber in people with Musculoskeletal Diseases and Mental Health Disorder, run by Molde University College at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Musculoskeletal Diseases, Mental Health Disorder, Back Pain, Low
- What is being tested?
- Virtual Reality with Beat Saber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2022to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Applying for a full disability pension;
- Unable to complete the measures and receive instructions in Norwegian.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian National Advisory Unit on Occupational Rehabilitation
Rauland, 3864
About this study
Official title: 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.
Read more
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.
- Conditions
- Musculoskeletal Diseases, Mental Health Disorder, Back Pain, Low, Anxiety Disorders, Depression
- Being tested
- Virtual Reality with Beat Saber
- Keywords
- Virtual reality, gaming, occupational rehabilitation, patient experience, quanitative study, qualitative study
- Medical subject headings
- Musculoskeletal Diseases, Mental Disorders, Low Back Pain, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality with Beat SaberDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Comparing VR training and ABM training | Experimental | 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). Receives: Device: Virtual Reality with Beat Saber |
| Patients' experiences with the usage of VR. | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Increase work ability
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).
Measured: Baseline and discharge (four weeks), and 6 and 12 months after discharge
Reduced depression and anxiety
Self-reported questionnaire measure, (The Hospital Anxiety And Depression Scale).
Measured: Baseline and discharge (four weeks)
Increase expectations to return to work
Self-reported questionnaire measures, (Return-to-Work Expectation)
Measured: Baseline and discharge (four weeks), and 6 and 12 months after discharge
Secondary outcomes (4)
Increased cognitive performance and attention
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.
Measured: Baseline and discharge (four weeks)
Increased cognitive performance and memory
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.
Measured: Baseline and discharge (four weeks)
Increased cognitive performance
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.
Measured: Baseline and discharge (four weeks)
Patients's experiences in using VR
Interview guide based on the participants experience.
Measured: From discharge up to 5 month after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start1 Jan 2022
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a non-randomised controlled experiment where we aim to recruit 20 patients from each of the six clinics involved in ABM training and up 100 from each of the clinics involved in VR. That is, 10 receiving ABM training and 10 in the control group, and 60 receiving VR and 40 in the control group. The participants will complete the questionnaires and cognitive measures one the day of arrival and on the penultimate or ultimate day of the rehabilitation/treatment. The measures will take approximately one hour to complete at each measurement point and will not interfere with the participation in the rehabilitation/treatment. In the qualitative part of this pilot, it is aimed to recruit 15 patients, five at each of the three clinics.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molde University College
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian National Advisory Unit on Occupational Rehabilitation
- Responsible party
- Principal investigator, Anita Dyb Linge, Molde University College
- Investigators
- Chris Jensen, PhD, Study director, Norwegian National Advisory Unit on Occupational Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410794
- Sponsor's protocol ID
- 254368
- Status last verified
- May 2024
- First submitted
- 23 Apr 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work-related Attention Bias Modification Training and Virtual Reality Training in Occupational Rehabilitation: A Multisite Pilot Study
- ClinicalTrials.gov ID
- NCT06410794
- Acronym / sponsor ID
- 254368
- Conditions
- Musculoskeletal Diseases, Mental Health Disorder, Back Pain, Low, Anxiety Disorders, Depression
- Keywords
- Virtual reality, gaming, occupational rehabilitation, patient experience, quanitative study, qualitative study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Molde University CollegeUniversity, hospital or other
- Collaborators
- Norwegian National Advisory Unit on Occupational Rehabilitation
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a non-randomised controlled experiment where we aim to recruit 20 patients from each of the six clinics involved in ABM training and up 100 from each of the clinics involved in VR. That is, 10 receiving ABM training and 10 in the control group, and 60 receiving VR and 40 in the control group. The participants will complete the questionnaires and cognitive measures one the day of arrival and on the penultimate or ultimate day of the rehabilitation/treatment. The measures will take approximately one hour to complete at each measurement point and will not interfere with the participation in the rehabilitation/treatment. In the qualitative part of this pilot, it is aimed to recruit 15 patients, five at each of the three clinics.
| Arm | Type | Receives |
|---|---|---|
| Comparing VR training and ABM training | Experimental | Device: Virtual Reality with Beat SaberThe 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). |
| Patients' experiences with the usage of VR. | No intervention | –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. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Applying for a full disability pension;
- Unable to complete the measures and receive instructions in Norwegian.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality with Beat SaberThe 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. | Device | Comparing VR training and ABM training |
Primary outcome
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).
Reduced depression and anxiety
Time frame: Baseline and discharge (four weeks)
Self-reported questionnaire measure, (The Hospital Anxiety And Depression Scale).
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)
4 secondary outcomes
Increased cognitive performance and attention
Time frame: Baseline and discharge (four weeks)
Increased cognitive performance and memory
Time frame: Baseline and discharge (four weeks)
Increased cognitive performance
Time frame: Baseline and discharge (four weeks)
Patients's experiences in using VR
Time frame: From discharge up to 5 month after discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Jensen, PhD study director
Norwegian National Advisory Unit on Occupational Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality with Beat Saber in people with Musculoskeletal Diseases and Mental Health Disorder, run by Molde University College at 1 site in Norway.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Results are not available in the source record.
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?
Increase work ability (time frame: Baseline and discharge (four weeks), and 6 and 12 months after discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2024.