None listed
Conditions
Brief summary
Objectives: The primary objective is to evaluate the efficacy of a psychological intervention for treating co-occurring anxiety and depression in patients with Parkinson’s disease in comparison to treatment as usual. The secondary objectives are to evaluate the impact of the psychological intervention on carer’s levels of distress and burden. Study design : Blinded RCT with two conditions: CBT and Treatment as Usual. Planned sample size: N = 40 (n = 20 for each condition). Selection criteria: Inclusion criteria are participants aged 50 years and over with a diagnosis of Parkinson’s disease and patient reported clinically significant anxiety symptoms (Geriatric Anxiety Inventory >6) and depressive symptoms (Geriatric Depression Scale -15 scores > 5). The patient’s spouse or carer will be invited to participate. The exclusion criteria are the presence of active suicide ideation, psychos is, substance abuse, uncontrolled bipolar disorder limited English literacy or significant cognitive impairment (2 or more errors on the Six Item Screener for Cognitive Impairment). Use of psychiatric medication will be required to be stabilised one month prior to study entry. Study procedure: Written and informed consent will first be gained for both the participants and carers. Participants and caregivers will complete the self-report measures. Suitable participants will be randomly allocated (via a computer generated randomisation list allocated to sealed envelopes) to receive the intervention face to face or treatment as usual. At the end of 10 weeks, participants and caregivers will recomplete psychometric measures, as well as again I month after treatment has finished (1 month follow up). Participants and carers in both treatment groups will complete all psychometric measures pre-, post- and 1 month post intervention. Patients who received CBT will complete the consumer feedback interview at the end of CBT. Analysis plan: Analyses will be conducted using intention-to-treat. Categorical data will be analysed via chi-squared tests, and continuous data with parametric or equivalent non-parametric tests including mixed linear models. Duration of the Study June 2016 – June 2017 (including follow-ups)
Interventions
A 1 x 1 hour session per week for 10 weeks manualised Cognitive Behavioural Therapy program will be delivered individually with participants with Parkinson's disease and their carers over the telephone.The program will be delivered by Clinical Psychologists and Clinical Psychology registrars, supervised by the Chief Investigators to ensure treatment adherence.
Sponsors
Macquarie University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients with Parkinson's disease and their primary carer will be recruited. Eligibility criteria will include aged 50 years or over, the presence of patient reported clinically significant anxiety symptoms (Geriatric Anxiety Inventory > 6) and depressive symptoms (Geriatric Depression Scale -15 scores > 5). Use of psychiatric medication will be required to be stabilised one month prior to study entry. Other than being the carer or spouse of the participant with Parkinson’s disease, and being over the age of 18 years, no other inclusion criteria are required.
Exclusion criteria
Exclusion criteria will be the presence of active suicide ideation, psychos is, substance abuse, uncontrolled bipolar disorder or significant cognitive impairment (2 or more errors on the Six Item Screener for Cognitive Impairment). Participants or carers with insufficient English Language skills (unable to read a newspaper) will also be excluded.
Outcome results
None listed