None listed
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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.
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.