Feasibility of a Behavioural Activation Protocol to Support People With Parkinson's Enhanced by VR

NCT07038603 | Completed DMC

• 1 other identifier: B22/27
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed research project will involve developing and testing the feasibility of a 6 week Behavioural Activation (BA) programme for people with Parkinson's Disease, which will be enhanced by Virtual Reality exercise programme. The aim of the programme will be to support the mental well-being and physical rehabilitation of people with Parkinson's Disease who are known to Marie Curie Outpatient Department (Belfast). The main question\[s\] it aims to answer are: Is a Behavioural Activation (BA) enhanced by a Virtual Reality exercise programme feasible and can it support the mental well-being and physical rehabilitation of People with Parkinson's Disease ? Can the potential impacts of the intervention help to reduce anxiety and depression, as well as improve balance, social interaction and adherence to the programme? Participants will:

• Attend a group for 6 weeks with the addition of an introductory session, for 1.5 hours per session.
• During sessions they will be asked to take part in a Behavioural Activation talking therapy. The aim of the intervention is to engage patients through activation strategies and help support adherence to exercise programmes. Participants will complete 'homework' tasks between sessions.
• In addition to this, the BA intervention will be enhanced by Virtual Reality exercises and participants will complete exercises within the immersive space using a VR headset.
• Data collection will capture any changes in depression, anxiety, balance,social interaction and adherence to the programme.
• The intervention will be carried out in three phases.

Conditions

Parkinson Disease

Keywords

anxiety; depression

Outcome Measures

Primary Outcomes (3)

• GAD-7

  Anxiety Measure - lower score better outcome - out of possible score of 21

  From enrolment to the end of treatment - week 6

• Berg Balance Scale

  Balance test - higher score better outcome - out of possible score of 56

  From enrolment to the end of treatment - week 6

• PHQ-9

  Derpession measure - lower score better outcome -out of possible score of 27

  From enrolment to the end of treatment - week 6

Study Arms (1)

Behavioural Activation enhanced by Virtual Reality exercises

EXPERIMENTAL

Participants will attend a 6 week BA group talking therapy (50mins-1hour) followed by a (30 min) exercise session enhanced with the use of Virtual Reality. Participants will be immersed in a virtual reality forest where they will complete a variety of physio chosen exercises. This intervention will be run in three phases.

Other: BAPP-VR

Interventions

BAPP-VR OTHER

A carefully considered adaptation of a BA protocol enhanced with the use of VR

Behavioural Activation enhanced by Virtual Reality exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of Idiopathic Parkinson's Disease which has been diagnosed by a neurologist.
• Patients with an early to moderate disease stage Hoehn and Yahr scale 1-3
• Patients with a BERG Balance Scale \> 45
• Currently not attending any other rehab programme/participation in another clinical trial
• Able to exercise independently \& mobilise
• No hospitalisation or medication change within the past month
• No other serious medical or surgical condition
• Carers:
• Have direct contact with a participant on the BAPP-VR programme in the role of a carer.
• Healthcare staff:
• Have helped in some capacity to facilitate the intervention or referred patients to BAPP-VR

You may not qualify if:

• Those who are unwilling/unable to provide written consent to participate
• Not receiving another form of psychotherapy
• Actively suicidal
• No other Neurological Condition
• Vision/ auditory impairment.
• Carers and healthcare staff:
• Those who are unwilling/unable to provide written consent to participate

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Marie Curie Hospice, Belfast: collaborator
• Parkinson's UK: collaborator

Study Sites (1)

Marie Curie

Belfast, BT5 6NF, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Paul Best, Reader

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The single group study is a small-scale feasibility study using a pre-test and post-test design. All participants will receive the same/ adapted Behavioural Activation (BA) protocol and Virtual Reality exercise programme.

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: June 26, 2025
• Study Start: April 5, 2023
• Primary Completion: December 20, 2023
• Study Completion: November 1, 2024
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)