None listed
Conditions
Brief summary
Parkinson’s disease (PD) is an age-related incurable disorder observed in 3% of persons aged 65 years old and over, and 10% of those aged over 80 years old, making it one of the more common neurological disorders of later life. In Australia, 1 in every 340 people lives with this condition. The prevalence of anxiety in PD exceeds 50%, and it is a major contributor to a poor quality of life of patients and caregivers. However, anxiety is poorly identified in PD. There is a paucity of clinical trials primarily focussed on treating anxiety, and there are no evidence based effective and safe pharmacological treatment for anxiety in PD. To complicate matters further, anxiety in PD presents with unique and complex symptomatology which must be understood and addressed if intervention is to be effective. There is an urgent need for empirically validated interventions targeting PD-specific anxiety symptoms for successful treatment. The present study will be the first to provide empirical evidence for Cognitive Behaviour Therapy (CBT) for anxiety by conducting a waitlist-controlled tailored and dyadic CBT trial including PD patients and caregivers. The study also focuses on caregiver well-being and the relationship quality and satisfaction for PD and caregivers. The ultimate goal of the present proposal is to improve diagnosis and treatment of anxiety in PD; thus improve quality of life of patients and their caregivers. METHODS PD patients will be recruited from neurology outpatient clinics in Brisbane. Their carers will also be invited to participate in the study. Apart from neurology outpatient clinics, PD patients and their carers who express interest to participate in PD research through other PD studies, support groups and advertisements will also be recruited. Research design: This study is a randomised wait-list controlled intervention design. PD patients with anxiety will be randomly allocated to either the Cognitive Behaviour Therapy (CBT) intervention group (group 1) or control group. The wait-list control group will receive clinical monitoring and educational material about PD. The wait-list group will receive the intervention after group 1 completes the intervention.
Interventions
The intervention will be conducted a week after the baseline assessment (Time 1). The intervention will include 6 weekly manualised Cognitive Behaviour Therapy (CBT) sessions tailored to address Parkinson's disease issues. It will be delivered in a dyad of PD patients and caregivers. Caregivers will be invited to engage in the therapy sessions to support the person with PD. Each therapy session will last 1-1.5 hours and will be conducted face-to-face by a clinical psychologist or a provisionally
The intervention will be conducted a week after the baseline assessment (Time 1). The intervention will include 6 weekly manualised Cognitive Behaviour Therapy (CBT) sessions tailored to address Parkinson's disease issues. It will be delivered in a dyad of PD patients and caregivers. Caregivers will be invited to engage in the therapy sessions to support the person with PD. Each therapy session will last 1-1.5 hours and will be conducted face-to-face by a clinical psychologist or a provisionally registered psychologist undergoing advanced postgraduate training at the University of Queensland’s School of Psychology. Intervention sessions will be conducted at the UQCCR or UQ Psychology Clinic at St. Lucia. Record of attendance will be obtained at each therapy session. During the therapy sessions PD patients and their caregivers will learn, and practice techniques concerning the following topics: - Psychoeducation, and symptom monitoring focused on PD-specific anxiety symptomatology such as anxiety associated with (i) motor symptoms, (ii) motor fluctuations, (iii) dyskinesias, and (iv) PD medication induced addictive behaviours (e.g. impulse control disorders, dopamine dysregulation syndrome), - Calming techniques of deep breathing, - Relaxation using progressive muscle relaxation or imagery (e.g. people with severe muscular rigidity and associated cramping can find it difficult to practice progressive muscle relaxation), - Sleep hygiene, and - Relapse prevention. PD patients will be encouraged to practice these skills between sessions. To help with this practice PD patients will receive printed material and worksheets during each therapy session, which are to be completed before the next therapy session. Caregivers will be encouraged to help the PD patient they care for to practice the new skills.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
PD patients scoring greater than threshold on self-report Parkinson’s Anxiety Scale (PAS) (>13)
Exclusion criteria
People with co-morbid neurological disorders, dementia identified by the referring neurologist or scoring below the cut-off for PD-dementia (<22) on the Montreal Cognitive Assessment (MoCA), and a high risk of suicide identified by neurologist or by the Mini International Neuropsychiatric Interview (MINI-Plus) suicide item. Persons (carer or patient with Parkinson's disease) under care currently of a psychologist/psychiatrist and currently receiving psychotherapy will be excluded from the trial. Parkinson's disease patients receiving pharmacotherapy alone (e.g. antidepressant medication) will be included and noted as receiving such treatment and analysed accordingly.
Outcome results
None listed