Trial Review

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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] 293363 0
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 305483 0
Anxiety 305484 0
Condition category
Condition code
Neurological 304738 304738 0 0
Parkinson's disease
Mental Health 304739 304739 0 0
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] 299620 0
Treatment: Other
Intervention code [2] 301513 0
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] 303953 0
Patient anxiety assessed by the Parkinson Anxiety Scale (PAS)
Timepoint [1] 303953 0
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] 340530 0
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] 340530 0
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] 340531 0
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] 340531 0
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] 340532 0
Patient cognition assessed by the Parkinson’s Disease Cognitive Rating Scale (PDCRS) to obtain details of cognitive impairment.
Timepoint [3] 340532 0
Week 1: Baseline assessment (Time 1)
Secondary outcome [4] 343139 0
Outcome for carers: Carer anxiety, depression and tension/stress severity assessed by the Depression, Anxiety and Stress Scale (DASS).
Timepoint [4] 343139 0
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 [5] 343143 0
Outcome for carers: Carer anxiety assessed by the Geriatric Anxiety Inventory (GAI)
Timepoint [5] 343143 0
Week 1: Baseline assessment (Time 1)
Week 10: Post intervention assessment (Time 2)
Week 21: Follow-up assessment (Time 3)
Secondary outcome [6] 345994 0
Outcome for carers: Carer burden assessed by the Zarit Burden Inventory (ZBI)
Timepoint [6] 345994 0
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 [7] 345995 0
Outcome for carers: Carer appraisal of caregiving experience assessed by the Positive Aspects of Caregiving (PAC)
Timepoint [7] 345995 0
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 [8] 345997 0
Outcome for patients: Patient depression assessed by the Geriatric Depression Scale (GDS-15)
Timepoint [8] 345997 0
Week 1: Baseline assessment (Time 1)
Week 10: Post intervention assessment (Time 2)
Week 21: Follow-up assessment (Time 3)
Secondary outcome [9] 346003 0
Outcome for patients: Patient quality of life assessed by the Parkinson's Disease Quality of Life Questionnaire (PDQ-8)
Timepoint [9] 346003 0
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 [10] 346004 0
Outcome for patients: Patient severity of social anxiety assessed by the Liebowitz Social Anxiety Scale (LSAS)
Timepoint [10] 346004 0
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 [11] 351264 0
Outcome for patients: Patient sleep quality assessed by the Parkinson's Disease Sleep Scale-2
Timepoint [11] 351264 0
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

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?
No
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
20
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9396 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 9397 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 18096 0
4029 - Herston
Recruitment postcode(s) [2] 18097 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 297985 0
Charities/Societies/Foundations
Name [1] 297985 0
Brain and Behavior Research Foundation
Country [1] 297985 0
United States of America
Funding source category [2] 298602 0
Charities/Societies/Foundations
Name [2] 298602 0
Royal Brisbane and Women's Hospital Foundation
Country [2] 298602 0
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] 297054 0
Hospital
Name [1] 297054 0
Royal Brisbane and Women's Hospital
Address [1] 297054 0
Bowen Bridge Rd & Butterfield St, Herston QLD 4029
Country [1] 297054 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299027 0
Univeristy of Queensland, Human Research Ethics Committee
Ethics committee address [1] 299027 0
Office of Research Ethics, The University of Queensland, Cumbrae-Stewart Building #72 Brisbane Queensland 4072, Australia
Ethics committee country [1] 299027 0
Australia
Date submitted for ethics approval [1] 299027 0
25/01/2018
Approval date [1] 299027 0
29/01/2018
Ethics approval number [1] 299027 0
2018000139
Ethics committee name [2] 299565 0
Royal Brisbane and Women's Hospital
Ethics committee address [2] 299565 0
Bowen Bridge Rd & Butterfield St, Herston QLD 4029
Ethics committee country [2] 299565 0
Australia
Date submitted for ethics approval [2] 299565 0
23/11/2017
Approval date [2] 299565 0
23/01/2018
Ethics approval number [2] 299565 0
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 79034 0
Dr Nadeeka Dissanayaka
Address 79034 0
University of Queensland Centre for Clinical Research,
Building 71/918 Royal Brisbane & Women's Hospital Campus
Herston QLD 4029
Country 79034 0
Australia
Phone 79034 0
+61 7 33466026
Fax 79034 0
Email 79034 0
[email protected]
Contact person for public queries
Name 79035 0
Dr Nadeeka Dissanayaka
Address 79035 0
University of Queensland Centre for Clinical Research,
Building 71/918 Royal Brisbane & Women's Hospital Campus
Herston QLD 4029
Country 79035 0
Australia
Phone 79035 0
+61 7 33466026
Fax 79035 0
Email 79035 0
[email protected]
Contact person for scientific queries
Name 79036 0
Dr Nadeeka Dissanayaka
Address 79036 0
University of Queensland Centre for Clinical Research,
Building 71/918 Royal Brisbane & Women's Hospital Campus
Herston QLD 4029
Country 79036 0
Australia
Phone 79036 0
+61 7 33466026
Fax 79036 0
Email 79036 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.