Virtual Reality Training in Occupational Rehabilitation

Depression Clinical Trial

Official title:

Work-related Attention Bias Modification Training and Virtual Reality Training in Occupational Rehabilitation: A Multisite Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06410794
• Other study ID #: 254368
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2024
• Source: Molde University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Virtual Reality with Beat Saber
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.

Locations

Country	Name	City	State
Norway	Norwegian National Advisory Unit on Occupational Rehabilitation	Rauland

Sponsors (2)

Lead Sponsor	Collaborator
Molde University College	Norwegian National Advisory Unit on Occupational Rehabilitation

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Reduced depression and anxiety	Self-reported questionnaire measure, (The Hospital Anxiety And Depression Scale).	Baseline and discharge (four weeks)
Primary	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	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.	Baseline and discharge (four weeks)
Secondary	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.	Baseline and discharge (four weeks)
Secondary	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.	Baseline and discharge (four weeks)
Secondary	Patients's experiences in using VR	Interview guide based on the participants experience.	From discharge up to 5 month after discharge.