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Trial registered on ANZCTR


Registration number
ACTRN12616000764437
Ethics application status
Approved
Date submitted
31/05/2016
Date registered
10/06/2016
Date last updated
27/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised wait-list controlled trial of Cognitive Behavior Therapy (CBT) for Anxiety in Parkinson's disease
Scientific title
Randomised wait-list controlled trial of Cognitive Behavior Therapy (CBT) for Anxiety in Parkinson's disease
Secondary ID [1] 289252 0
Nil known
Universal Trial Number (UTN)
U1111-1183-0643
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 298828 0
Anxiety 298962 0
Condition category
Condition code
Neurological 298889 298889 0 0
Parkinson's disease
Mental Health 299031 299031 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 294796 0
Treatment: Other
Intervention code [2] 294947 0
Behaviour
Comparator / control treatment
Parkinson's disease (PD) patients with anxiety will be randomly allocated to either the CBT intervention group (group 1) or wait-list control group (group 2). The wait-list control group will receive clinical monitoring and educational material about PD which will cover the following topics: psychoeducation, symptom monitoring, calming techniques of deep breathing, relaxation using progressive muscle relaxation or imagery, sleep hygiene, and relapse prevention. The wait-list group will receive the intervention after group 1 completes the intervention and post clinical assessment (i.e. they will commence intervention after 6 weeks from baseline assessment).
Control group
Active

Outcomes
Primary outcome [1] 298359 0
Proportion of participants with a significant reduction in anxiety, defined as a score of <13 on the Parkinson Anxiety Scale (PAS).
Timepoint [1] 298359 0
Week 1-2
Baseline assessment (Time 1): CBT intervention group 1 and Waitlist Control.

Week 5
Midpoint intervention assessment (After 3 therapy sessions): CBT intervention group 1

Week 9
Post intervention assessment (Time 2): CBT intervention group 1 Post waitlist assessment (Time 2): Waitlist Control

Week 13
Midpoint intervention assessment (after 3 therapy sessions): CBT intervention group 2 (i.e. Waitlist Control)

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Primary outcome [2] 298533 0
Proportion of participants with a reduction of anxiety disorder according to the Diagnosis and Statistical Manual for Psychiatric Disorders edition 5 criteria.
Timepoint [2] 298533 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [1] 323934 0
Mean change in score on the Hamilton Anxiety Rating Scale (HAMA)
Timepoint [1] 323934 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [2] 323935 0
Mean change in score on the Liebowitz Social Anxiety Scale (LSAS)
Timepoint [2] 323935 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [3] 323940 0
Mean change in score on the Informant Questionnaire for Anxiety in Dementia (IQAD)
Timepoint [3] 323940 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [4] 324362 0
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)
Timepoint [4] 324362 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [5] 324363 0
Mean change in score on the Geriatric Depression Scale (GDS-15)
Timepoint [5] 324363 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [6] 324489 0
Mean change in score on the Hamilton Depression Scale (HAMD)
Timepoint [6] 324489 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [7] 324490 0
Proportion of participants with a reduction of depression according to the Diagnosis and Statistical Manual for Psychiatric Disorders edition 5 criteria.
Timepoint [7] 324490 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [8] 324491 0
Mean change in score on the Unified Parkinson's disease rating scale (UPDRS).
Timepoint [8] 324491 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [9] 324492 0
Mean change in score on the Montreal Cognitive Assessment (MoCA)
Timepoint [9] 324492 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [10] 324493 0
Mean change in score on the Parkinson's Disease Cognitive Rating Scale (PDCRS)
Timepoint [10] 324493 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [11] 324494 0
Mean change in score on the Parkinson’s Disease Quality of Life Questionnaire (PDQ-39)
Timepoint [11] 324494 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [12] 324495 0
Mean change in score on the Depression, Anxiety and Stress Scale (DASS) for Caregivers
Timepoint [12] 324495 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [13] 324496 0
Mean change in score on the Geriatric Depression Scale (GDS-15) for Caregivers
Timepoint [13] 324496 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [14] 324497 0
Mean change in score on the Geriatric Anxiety Inventory (GAI) for Caregivers
Timepoint [14] 324497 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [15] 324498 0
Mean change in score on the Brief Cope Sale (COPE) for Caregivers
Timepoint [15] 324498 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [16] 324499 0
Mean change in score on the Positive Aspects of Caregiving (PAC)
Timepoint [16] 324499 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [17] 324500 0
Mean change in score on the Zarit Burden Inventory (ZBI) for Caregivers
Timepoint [17] 324500 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [18] 324501 0
Mean change in score on the Quality of life Questionnaire for Carers (PDQ-Carer)
Timepoint [18] 324501 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [19] 324502 0
Mean change in score on the dyadic adjustment scale (DAS). The DAS measures the relationship quality and satisfaction between patients and caregiver
Timepoint [19] 324502 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)
Secondary outcome [20] 324503 0
Mean change in score on the Couple's Satisfactory Index (CSI). The CSI measures the relationship quality and satisfaction between patients and caregiver
Timepoint [20] 324503 0
Week 1-2
Baseline (Time 1): CBT intervention group 1 and Waitlist Control.

Week 9
Post intervention assessment (Time 2): CBT intervention group 1
Post waitlist assessment (Time 2): Waitlist Control

Week 16
Post intervention assessment (Time 2): CBT intervention group 2 (i.e. Waitlist Control)

Eligibility
Key inclusion criteria
PD patients scoring greater than threshold on self-report Parkinson’s Anxiety Scale (PAS) (>13)
Minimum age
20 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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)
Allocation is concealed.

We will use sealed opaque envelops. Once envelops are given to patients a research assistant who is not involved with assessments will ask patients to reveal their allocation and will further discuss their role in each group. This person will be responsible for liaising with therapists and setting up post assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
PD patients satisfying all inclusion/exclusion criteria will be randomly allocated to the intervention or control group using a computer generated random sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Waitlist controlled
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: To make case-control comparisons pre (Time 1) and post (Time 2) treatment or waitlist conditions, with large effect sizes at 80% with a p value of 0.05, at least 30 PD patients with anxiety are required (Cohen J. A Power Primer. Psychol Bull 1992; 112(1): 155-9). PD patients will be randomly allocated to intervention or waitlist control. In our pilot study, we had an attrition rate of 30%. Therefore, this proposal will require at least 46 PD patients with anxiety to commence the CBT intervention, and thus each group (intention and control) will consist 23 PD patients and 23 carers.

Data analysis: Multilevel linear mixed-effects modelling using “MIXED” procedure in SPSS software package will be used. Separate models will be conducted to analyse outcome measures of each scale outlined above. Change in outcomes between pre (Time 1) and post (Time 2) assessments will be assessed comparing between treatment condition and control condition. A significant Time X Condition interaction will indicate a differential rate of change in outcomes between the intervention and control condition from Time 1 to 2.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/06/2016
Actual
11/07/2016
Date of last participant enrolment
Anticipated
29/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5841 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 13286 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 293667 0
Hospital
Name [1] 293667 0
Royal Brisbane & Women's Hospital
Country [1] 293667 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 292502 0
Hospital
Name [1] 292502 0
Royal Brisbane & Women's Hospital
Address [1] 292502 0
Butterfield Street
Herston QLD 4029
Country [1] 292502 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295106 0
Royal Brisbane & Women's Hospital Human Research Committee
Ethics committee address [1] 295106 0
Level 7, Block 7
Butterfield Street
Herston QLD 4029
Ethics committee country [1] 295106 0
Australia
Date submitted for ethics approval [1] 295106 0
28/03/2016
Approval date [1] 295106 0
06/05/2016
Ethics approval number [1] 295106 0
HREC/16/QRBW/159
Ethics committee name [2] 295107 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 295107 0
The University of Queensland
Cumbrae-Stewart Building #72
Brisbane, QLD 4072
Ethics committee country [2] 295107 0
Australia
Date submitted for ethics approval [2] 295107 0
10/05/2016
Approval date [2] 295107 0
17/05/2016
Ethics approval number [2] 295107 0
2016000717

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65982 0
Dr Nadeeka Dissanayaka
Address 65982 0
University of Queensland Centre for Clinical Research (UQCCR)
Building 91/718
Royal Brisbane & Women's Hospital
Herston QLD 4029
Country 65982 0
Australia
Phone 65982 0
+61 7 3346 5577
Fax 65982 0
Email 65982 0
[email protected]
Contact person for public queries
Name 65983 0
Nadeeka Dissanayaka
Address 65983 0
University of Queensland Centre for Clinical Research (UQCCR)
Building 91/718
Royal Brisbane & Women's Hospital
Herston QLD 4029
Country 65983 0
Australia
Phone 65983 0
+61 7 3346 5577
Fax 65983 0
Email 65983 0
[email protected]
Contact person for scientific queries
Name 65984 0
Nadeeka Dissanayaka
Address 65984 0
University of Queensland Centre for Clinical Research (UQCCR)
Building 91/718
Royal Brisbane & Women's Hospital
Herston QLD 4029
Country 65984 0
Australia
Phone 65984 0
+61 7 3346 5577
Fax 65984 0
Email 65984 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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