Randomised wait-list controlled trial of Cognitive Behavior Therapy (CBT) for Anxiety in Parkinson's disease

INTERVENTION: 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. CONDITION: Anxiety Parkinson's disease PRIMARY OUTCOME: Proportion of participants with a reduction of anxiety disorder according to the Diagnosis and Statistical Manual for Psychiatric Disorders edition 5 criteria. Proportion of participants with a significant reduction in anxiety, defined as a score of <13 on the Parkinson Anxiety Scale (PAS). SECONDARY OUTCOME: Mean change in score on the Brief Cope Sale (COPE) for Caregivers ; Mean change in score on the Montreal Cognitive Assessment (MoCA) Mean change in score on the Parkinson's Disease Cognitive Rating Scale (PDCRS) Mean change in score on the Parkinson’s Disease Quality of Life Questionnaire (PDQ‐39) Mean change in score on the Positive Aspects of Caregiving (PAC) ; Mean change in score on the Quality of life Questionnaire for Carers (PDQ‐Carer) Mean change in score on the Unified Parkinson's disease rating scale (UPDRS). Mean change in score on the Zarit Burden Inventory (ZBI) for Caregivers Proportion of participants with a reduction in anxiety symptoms relating to Parkinson's disease assessed by the Parkinson's disease anxiety and motor complications questionnaire (PDAMC) and Parkinson's Disease Specific Anxiety Inventory (PD‐SAI) Proportion of participants with a reduction of depression according to the Diagnosis and Statistical Manual for Psychiatric Disorders edition 5 criteria. INCLUSION CRITERIA: PD patients scoring greater than threshold on self‐report Parkinson’s Anxiety Scale (PAS) (>13) ; Mean change in score on the Couple's Satisfactory Index (CSI). The CSI measures the relationship quality and satisfaction between patients and caregiver Mean change in score on the Depression, Anxiety and Stress Scale (DASS) for Caregivers Mean change in score on the dyadic adjustment scale (DAS). The DAS measures the relationship quality and satisfaction between patients and caregiver Mean change in score on the Geriatric Anxiety Inventory (GAI) for Caregivers Mean change in score on the Geriatric Depression Scale (GDS‐15) Mean change in score on the Geriatric Depression Scale (GDS‐15) for Caregivers Mean change in score on the Hamilton Anxiety Rating Scale (HAMA) Mean change in score on the Hamilton Depression Scale (HAMD) Mean change in score on the Informant Questionnaire for Anxiety in Dementia (IQAD) Mean change in score on the Liebowitz Social Anxiety Scale (LSAS)