Virtual Reality Training in Occupational Rehabilitation

NCT06410794 | Active Not Recruiting

• 1 other identifier: 254368
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Musculoskeletal Diseases; Mental Health Disorder; Back Pain, Low; Anxiety Disorders; Depression

Keywords

Virtual reality; gaming; occupational rehabilitation; patient experience; quanitative study; qualitative study

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  Baseline and discharge (four weeks)

• Increase expectations to return to work

  Self-reported questionnaire measures, (Return-to-Work Expectation)

  Baseline and discharge (four weeks), and 6 and 12 months after discharge

Secondary Outcomes (4)

• Increased cognitive performance and attention

  Baseline and discharge (four weeks)

• Increased cognitive performance and memory

  Baseline and discharge (four weeks)

• Increased cognitive performance

  Baseline and discharge (four weeks)

• Patients's experiences in using VR

  From discharge up to 5 month after discharge.

Study Arms (2)

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).

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.

Interventions

Virtual Reality with Beat Saber DEVICE

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.

Comparing VR training and ABM training

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Applying for a full disability pension;
• Unable to complete the measures and receive instructions in Norwegian.

Sponsors & Collaborators

• Molde University College: lead
• Norwegian National Advisory Unit on Occupational Rehabilitation: collaborator

Study Sites (1)

Norwegian National Advisory Unit on Occupational Rehabilitation

Rauland, 3864, Norway

Location

MeSH Terms

Conditions

Musculoskeletal Diseases; Mental Disorders; Low Back Pain; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Chris Jensen, PhD

  Norwegian National Advisory Unit on Occupational Rehabilitation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research and Developement Manager

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 13, 2024
• Study Start: January 1, 2022
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)