ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001508268

Ethics application status

Approved

Date submitted

8/05/2018

Date registered

7/09/2018

Date last updated

9/03/2020

Date data sharing statement initially provided

9/03/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Virtual Reality to Treat Anxiety in Parkinson’s Disease

Scientific title

Virtual Reality to Treat Anxiety in Parkinson’s Disease

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1208-8381

Trial acronym

VRCBTPD

Linked study record

N/A

Health condition

Health condition(s) or problem(s) studied:

Parkinson's disease

Anxiety

Condition category

Condition code

Neurological

Parkinson's disease

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

CBT-VR Intervention with Homebased mobile-VR:
The new CBT-VR intervention with homebased applications and biofeedback is a modification of our existing manualised CBT for anxiety in Parkinson's disease (PD) patients which is described in our previously registered study (ACTRN12616000764437: Randomised wait-list controlled trial of Cognitive Behaviour Therapy (CBT) for Anxiety in Parkinson's Disease).

This new package will incorporate individually tailored methods to reduce anxiety. The package will target anxiety disorders common to PD. Participants will be required to attend 8 CBT sessions, once per week over 8 weeks with individually tailored immersive VR view, chosen from a library of VR applications, including VR applications widely used for the treatment of anxiety subtypes and tailored VR applications readily available for PD (e.g. VR walk on travelling in a train where PD patients often experience panic attacks). Each CBT-VR session lasting for 90 minutes maximum will be conducted at the University of Queensland clinical centres and will be facilitated by a clinical psychologist or a provisionally registered psychologist undergoing advanced postgraduate training at the School of Psychology, University of Queensland. In the proposed project, carers will be included more explicitly. Each session will have handout material with further information, and instructions for homebased anxiety treatment including use of mobile-VR coupled with a biofeedback watch.

Home Based Anxiety Treatment using Biofeedback:
PD patients in the CBT-VR intervention group - will take home a VR headset to home view the relaxation VR environment experienced during in-person clinic sessions. Participants will be asked to practise at least for 10 minutes daily. However, the frequency and duration of home based practise will vary for each individual. Participants are to record their use in a practise log. Training and instruction handouts will be provided for all participants. For biofeedback, Patients will be asked to wear the Garmin Smart Watch for the whole duration of the study period for anxiety monitoring, and for biofeedback alerts during high anxiety states. Patients will be given the option of either viewing the mobile-VR using VR headsets for an immersive experience or without VR-headsets for a non-immersive VR experience.

PD patients in the waitlist control group - will also receive a watch to record heart rate to compare data. However, during the wait period they will not have the alerting program. We will provide a demonstration of the use of all equipment to patients and carers at baseline assessments.

All PD patients will be asked to practice techniques gained in the in-person sessions at home and will be asked to maintain a practise log and monitoring of any side effects throughout the study. This practise log will be developed as part of the development phase of the study.

Intervention code [1]

Treatment: Other

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Parkinson's disease patients will either be allocated to one of two groups:
1. CBT-VR group, in which therapy will utilise VR technology (e.g. during the exposure component of the therapy participants will be shown scenarios using the VR headset) or
2. Waitlist control group, in which the participant will be asked to wait 8 weeks until they receive the intervention. During the wait period, participants will receive treatment as usual, meaning that they will continue all of their medical appointments (e.g., with their general practitioner, neurologist) as usual. As such, patients in the wait-list control group will be required to attend the clinical interviews and will be asked to complete six sets of questionnaires

Control group

Active

Outcomes

Primary outcome [1]

Patient anxiety assessed by the Parkinson Anxiety Scale (PAS)

Timepoint [1]

CBT-VR group: Week 1: Baseline assessment. Week 10: Post intervention assessment. Week 21: Follow-up assessment

Waitlist control group: Week 1: Baseline assessment. Week 10: Post waitlist assessment. Week 19: Post intervention assessment. Week 30: Follow-up assessment

Secondary outcome [1]

CBT-VR ease of use, accessibility and tolerability assessed by patient report in practice log and a qualitative questionnaire designed specifically for this study.

Timepoint [1]

CBT-VR group: Week 2-21: Throughout administration of CBT-VR sessions and home based anxiety treatment, and at post-intervention assessment and 3-months follow-up assessment.

Waitlist control group: Week 11-30: Throughout administration of CBT-VR sessions and home based anxiety treatment, and at post-intervention assessment and 3-months follow-up assessment.

Secondary outcome [2]

CBT-VR ease of use, accessibility and tolerability assessed by therapist report, participant practice log, Simulator Sickness Questionnaire, and a qualitative questionnaire designed specifically for this study.

Timepoint [2]

CBT-VR group: Week 2-9: Throughout administration of CBT-VR sessions.

Waitlist control group: Week 11-18: Throughout administration of CBT-VR sessions.

Secondary outcome [3]

Patient cognition assessed by the Parkinson’s Disease Cognitive Rating Scale (PDCRS) to obtain details of cognitive impairment.

Timepoint [3]

Week 1: Baseline assessment (Time 1)

Secondary outcome [4]

Outcome for carers: Carer anxiety, depression and tension/stress severity assessed by the Depression, Anxiety and Stress Scale (DASS).

Timepoint [4]

Secondary outcome [5]

Outcome for carers: Carer anxiety assessed by the Geriatric Anxiety Inventory (GAI)

Timepoint [5]

Week 1: Baseline assessment (Time 1)
Week 10: Post intervention assessment (Time 2)
Week 21: Follow-up assessment (Time 3)

Secondary outcome [6]

Outcome for carers: Carer burden assessed by the Zarit Burden Inventory (ZBI)

Timepoint [6]

Secondary outcome [7]

Outcome for carers: Carer appraisal of caregiving experience assessed by the Positive Aspects of Caregiving (PAC)

Timepoint [7]

Secondary outcome [8]

Outcome for patients: Patient depression assessed by the Geriatric Depression Scale (GDS-15)

Timepoint [8]

Week 1: Baseline assessment (Time 1)
Week 10: Post intervention assessment (Time 2)
Week 21: Follow-up assessment (Time 3)

Secondary outcome [9]

Outcome for patients: Patient quality of life assessed by the Parkinson's Disease Quality of Life Questionnaire (PDQ-8)

Timepoint [9]

Secondary outcome [10]

Outcome for patients: Patient severity of social anxiety assessed by the Liebowitz Social Anxiety Scale (LSAS)

Timepoint [10]

Secondary outcome [11]

Outcome for patients: Patient sleep quality assessed by the Parkinson's Disease Sleep Scale-2

Timepoint [11]

Eligibility

Key inclusion criteria

Established PD diagnosis according to the United Kingdom Brain Bank criteria and having a diagnosis of anxiety according to the DSM-5 criteria or the Parkinson’s Anxiety Scale
(PAS). Patients must score greater than >13 for PAS Total or >10 for PAS Persistent or >5 for PAS Episodic or >4 for PAS avoidance subscales.

Minimum age

30 Years

Maximum age

85 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Comorbid neurological disorders, currently receiving deep brain stimulation (DBS) therapy, a high risk of suicide identified by a neurologist or by the Mini International Neuropsychiatric Interview (MINI-Plus) suicide item, or moderate to severe cognitive impairment identified by the neurologist or scoring <22 in the Montreal Cognitive Assessment (MoCA) or PD patients currently receiving psychotherapy. Exclusion criteria will apply at baseline, post and follow-up assessments.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is concealed.

We will use sealed opaque envelops. Once envelops are given to patients a research assistant who is not involved with assessments will ask patients to reveal their allocation and will further discuss their role in each group. This person will be responsible for liaising with therapists and setting up post assessments.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

PD patients satisfying all inclusion/exclusion criteria will be randomly allocated to the CBT-VR intervention group or waitlist control group using a computer generated random sequence

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

For primary data analysis we will use the 2-sample proportion test comparing between groups using the within subject change in Parkinson's Anxiety Scale (PAS) measures between baseline and 3-month follow-up. Secondary analysis will include General Linear Model (GLM) fixed-effect models using SPSS statistical software package. Separate models will be conducted to analyse outcome measures of each scale outlined above and heart rate variability adjusted for age, gender, education level, and levodopa equivalent dosage calculated based on previous study for patients. Reliable change index analyses will be performed to evaluate number of participants demonstrating clinically significance change in each group. Predictors of response to treatment will be evaluated by regression modelling. This will include investigations of associations between cognitive impairment and response to anxiety treatment in each group. Thematic analyses will be performed for qualitative data.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/10/2018

Actual

25/03/2019

Date of last participant enrolment

Anticipated

29/11/2020

Actual

Date of last data collection

Anticipated

25/04/2021

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [2]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4029 - Herston

Recruitment postcode(s) [2]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Brain and Behavior Research Foundation

Address [1]

Brain & Behavior Research Foundation
90 Park Avenue, 16th Floor
New York, NY 10016

Country [1]

United States of America

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Royal Brisbane and Women's Hospital Foundation

Address [2]

Block 20 Royal Brisbane and Women’s Hospital, Butterfield St, Herston QLD 4006

Country [2]

Australia

Primary sponsor type

University

Name

University of Queensland Centre for Clinical Research

Address

Building 71/918 Royal Brisbane and Women's Hospital Campus, Herston, QLD 4029

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Royal Brisbane and Women's Hospital

Address [1]

Bowen Bridge Rd & Butterfield St, Herston QLD 4029

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Univeristy of Queensland, Human Research Ethics Committee

Ethics committee address [1]

Office of Research Ethics, The University of Queensland, Cumbrae-Stewart Building #72 Brisbane Queensland 4072, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/01/2018

Approval date [1]

29/01/2018

Ethics approval number [1]

2018000139

Ethics committee name [2]

Royal Brisbane and Women's Hospital

Ethics committee address [2]

Bowen Bridge Rd & Butterfield St, Herston QLD 4029

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

23/11/2017

Approval date [2]

23/01/2018

Ethics approval number [2]

HREC/17/QRBW/676

Summary

Brief summary

Anxiety is under-examined in Parkinson's disease (PD) patients, yet it is a major contributor to a poor quality of life in this population. Our previous study aimed at improving diagnosis and treatment of anxiety in PD was the first to pilot Cognitive Behavioural Therapy (CBT) for anxiety in PD using a tailored, manualised and dyadic protocol involving both PD and carers. This project develops and tests CBT incorporating Virtual Reality (VR) proposed to augment anxiety treatment in PD. 

VR environments (in virtuo experiences) have the potential to improve the efficacy of CBT treatment with the following unique benefits:
• Patients are not required to mentally reproduce the stimulus as in imaginal exposure and relaxation. This is an issue in persons with PD, as executive function and memory retrieval are often impaired even at early stages of the disease.
• Multi-sensory engagement provides a tangible and ‘real’ experience, improving patient engagement in the therapy.
• The environment can be tailored by the clinician based on the subcategory of anxiety.
• Relaxation immersive VR (eg: Virtual Meditative Walk) assists patients to focus attention inward which is advantageous in a population of patients with compromised attention.
• Current smart-phone technology is capable of running VR software to allow for home based remote delivery of VR therapy.

A randomised waitlist controlled feasibility trial will be conducted comparing the new CBT-VR to treatment as usual in reducing anxiety in PD (primary outcome). Secondary outcome measures will be depression, sleep, quality of life, and outcomes for carers. The manualised CBT-VR package will comprise of eight weekly sessions of 90 minutes each conducted at the University of Queensland. Additionally, patients will be given a mobile device with headsets for VR view at home with relaxation VR applications and a smart watch for monitoring of anxiety via heartrate. Basline, post and 3 month follow-up data will be collected.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Nadeeka Dissanayaka

Address

University of Queensland Centre for Clinical Research,
Building 71/918 Royal Brisbane & Women's Hospital Campus
Herston QLD 4029

Country

Australia

Phone

+61 7 33466026

Fax

n.dissanayaka@uq.edu.au

Contact person for public queries

Name

Nadeeka Dissanayaka

Address

University of Queensland Centre for Clinical Research,
Building 71/918 Royal Brisbane & Women's Hospital Campus
Herston QLD 4029

Country

Australia

Phone

+61 7 33466026

Fax

n.dissanayaka@uq.edu.au

Contact person for scientific queries

Name

Nadeeka Dissanayaka

Address

University of Queensland Centre for Clinical Research,
Building 71/918 Royal Brisbane & Women's Hospital Campus
Herston QLD 4029

Country

Australia

Phone

+61 7 33466026

Fax

n.dissanayaka@uq.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

We do not have ethical approval to share individual participant data

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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