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Trial registered on ANZCTR


Registration number
ACTRN12616000785404
Ethics application status
Approved
Date submitted
10/06/2016
Date registered
16/06/2016
Date last updated
13/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Psychological treatment of anxiety and depression in patients with Parkinson's disease: A pilot program
Scientific title
Psychological treatment of anxiety and depression in patients with Parkinson's disease: A pilot program
Secondary ID [1] 289418 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 299090 0
Anxiety 299123 0
Depression 299124 0
Condition category
Condition code
Mental Health 299121 299121 0 0
Anxiety
Mental Health 299122 299122 0 0
Depression
Neurological 299141 299141 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 295007 0
Treatment: Other
Intervention code [2] 295027 0
Behaviour
Comparator / control treatment
The control condition will be Treatment as Usual. As such participants will be given an letter to give to their General Practitioner indicating their involvement with the trial. Participants allocated to this condition will receive usual care from their General Practitioner or other providers.
Control group
Active

Outcomes
Primary outcome [1] 298591 0
Change in patient anxiety as assessed by the Geriatric Anxiety Inventory
Timepoint [1] 298591 0
Baseline and 10 weeks post commencement of the intervention (Post Intervention)
Primary outcome [2] 298592 0
Change in patient depression assessed by the Geriatric Depression Scale (15 item)
Timepoint [2] 298592 0
Baseline and 10 weeks post commencement of the intervention (Post Intervention)
Primary outcome [3] 298593 0
Change in patient quality of life as assessed by the World Health Organisation Quality of Life scale (short form) - WHOQOL-BRE
Timepoint [3] 298593 0
Baseline and 10 weeks post commencement of the intervention (Post Intervention)
Secondary outcome [1] 324672 0
Change in patient anxiety as assessed by the Geriatric Anxiety Inventory
Timepoint [1] 324672 0
Baseline and 1 month post the end of the intervention (1 month follow-up)
Secondary outcome [2] 324781 0
Change in patient depression assessed by the Geriatric Depression Scale (15 item)
Timepoint [2] 324781 0
Baseline and 1 month after the end of the intervention (1 month post follow up)
Secondary outcome [3] 324784 0
Change in patient quality of life as assessed by the World Health Organisation Quality of Life scale (short form) - WHOQOL-BRE
Timepoint [3] 324784 0
Baseline and 1 month after the end of the intervention (1 month follow up)
Secondary outcome [4] 324785 0
Change in Caregiver depression as assessed by the Depression, Anxiety and Stress Scale (21 item)
Timepoint [4] 324785 0
Baseline and 10 weeks post commencement of the intervention (Post Intervention)
Secondary outcome [5] 324786 0
Change in Caregiver anxiety as assessed by the Depression, Anxiety and Stress Scale (21 item)
Timepoint [5] 324786 0
Baseline and 10 weeks post commencement of the intervention (Post Intervention)
Secondary outcome [6] 324787 0
Change in Caregiver stress as assessed by the Depression, Anxiety and Stress Scale (21 item)
Timepoint [6] 324787 0
Baseline and 10 weeks post commencement of the intervention (Post Intervention)
Secondary outcome [7] 324788 0
Change in cargiver burden as measured by Zarit Caregiver Inventory (Short Form)
Timepoint [7] 324788 0
Baseline and 10 weeks post commencement of the intervention (Post Intervention)
Secondary outcome [8] 324789 0
Change in carer distress as assessed by the Zarit Caregiver Inventory (Short Form)
Timepoint [8] 324789 0
Baseline and 1 month after the end of the intervention (1 month follow up)
Secondary outcome [9] 324790 0
Change in carer depression as measured by the Depression, Anxiety and Stress scales (21 item)
Timepoint [9] 324790 0
Baseline and 1 month after the end of the intervention (1 month follow up)
Secondary outcome [10] 324791 0
Change in carer anxiety as measured by the Depression, Anxiety and Stress Scales (21 item)
Timepoint [10] 324791 0
Baseline and 1 month after the end of the intervention (1 month follow up)
Secondary outcome [11] 324792 0
Change in caregiver stress as measured by the Depression, Anxiety and Stress Scales (21 items)
Timepoint [11] 324792 0
Baseline and 1 month after the end of the intervention (1 month follow up)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

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)
Sealed envelopes that is compiled using a computer-based random number generator (www. Randomiser.org). The list and sealed envelopes will be created by Professor Ron Rapee who will have no direct access to patients.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-based random number generator (www. Randomiser.org).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293791 0
Charities/Societies/Foundations
Name [1] 293791 0
Parkinson's NSW
Address [1] 293791 0
Macquarie Hospital Building 17, 51 Wicks Rd, North Ryde, NSW 2113
Country [1] 293791 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University, Sydney, NSW 2109
Country
Australia
Secondary sponsor category [1] 292625 0
None
Name [1] 292625 0
Address [1] 292625 0
Country [1] 292625 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295226 0
Macquarie University Human Ethics Committee
Ethics committee address [1] 295226 0
Macquarie University, Sydney, NSW 2109
Ethics committee country [1] 295226 0
Australia
Date submitted for ethics approval [1] 295226 0
11/05/2016
Approval date [1] 295226 0
14/06/2016
Ethics approval number [1] 295226 0
Reference No: 5201600391

Summary
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)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66606 0
A/Prof Viviana Wuthrich
Address 66606 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Sydney, NSW 2109
Country 66606 0
Australia
Phone 66606 0
+ 61 2 9850 4866
Fax 66606 0
Email 66606 0
Viviana.Wuthrich@mq.edu.au
Contact person for public queries
Name 66607 0
A/Prof Viviana Wuthrich
Address 66607 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Sydney, NSW 2109
Country 66607 0
Australia
Phone 66607 0
+61 2 9850 4866
Fax 66607 0
Email 66607 0
viviana.wuthrich@mq.edu.au
Contact person for scientific queries
Name 66608 0
A/Prof Viviana Wuthrich
Address 66608 0
Centre for Emotional Health
Department of Psychology
Macquarie University
Sydney, NSW 2109
Country 66608 0
Australia
Phone 66608 0
+61 2 9850 4866
Fax 66608 0
Email 66608 0
viviana.wuthrich@mq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary