Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000287639
Ethics application status
Approved
Date submitted
12/03/2014
Date registered
19/03/2014
Date last updated
19/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of Mindfulness Based Cognitive Therapy for people with Parkinson's Disease
Scientific title
The effect of Mindfulness Based Cognitive Therapy on depression and anxiety levels in people with Parkinson's Disease
Secondary ID [1] 284255 0
Nil Known
Universal Trial Number (UTN)
U1111-1154-4498
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease
 291374 0
Depression 291375 0
Anxiety 291376 0
Condition category
Condition code
Neurological 291738 291738 0 0
Parkinson's disease
Mental Health 291760 291760 0 0
Depression
Mental Health 291761 291761 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Mindfulness Based Cognitive Therapy program is an intervention program designed specifically to reduce depression, anxiety, stress and distress associated with chronic illnesses (Segal, Williams, & Teesdale, 2002). During the program participants discover how thinking patterns promote depression and anxiety where a main aim of the program is to teach participants to stay in touch with the present moment and to avoid ruminating about past or worrying about future events.
The MBCT program for the current study will be adapted from the work of Segal, Williams and Teesdale (2002) and tailored for group delivery for people with Parkinson's Disease (Segal, Williams, & Teesdale, 2002). The manualised intervention program comprises 8 weekly sessions where each session runs for 120 minutes. The program will target skills such as experiential learning, concentration, bringing awareness of thoughts, emotions and bodily sensations, being in the moment, decentering, acceptance and being in a state of “non-doing”. Weekly handouts will be provided and a set of meditation CD’s that contain material covered in the weekly session for personal practice at home.
Intervention code [1] 288962 0
Behaviour
Intervention code [2] 288979 0
Treatment: Other
Comparator / control treatment
Waitlist Control
Waiting list control group
Upon completion of the intervention, the participants in the waitlist group will be offered the same intervention program. Throughout the study however, they will not receive any therapeutic assistance from the therapists assisting in the study. In order to ensure they remain part of the study, and to check that waiting for treatment is not detrimental, these participants will receive a monthly phone call or email. If participants are demonstrating the need for immediate intervention for example reporting the risk of suicide, then they will be withdrawn from the study and referred to appropriate treatment providers.
Control group
Active

Outcomes
Primary outcome [1] 291673 0
Geriatric Depression Scale-15 (GDS-15)
Timepoint [1] 291673 0
Pre-intervention
Post-intervention
3 month follow-up
Secondary outcome [1] 307266 0
The Parkinson’s Disease Questionnaire-39 (PDQ-39)
Timepoint [1] 307266 0
Pre-intervention
Post-intervention
3 month follow-up
Secondary outcome [2] 307267 0
Geriatric Anxiety Inventory (GAI)
Timepoint [2] 307267 0
Pre-intervention
Post-intervention
3 month follow-up
Secondary outcome [3] 307268 0
Frieburg Mindfulness Inventory (FMI)
Timepoint [3] 307268 0
Pre-intervention
Post-intervention
3 month follow-up

Eligibility
Key inclusion criteria
The inclusion criteria are: a) a diagnosis of PD b) scoring greater than or equal to 24 on the MMSE, c) not participating in any psychotherapy or other interventions over the course of the study and d) over the age of 18 years. Participants who meet these criteria will be randomised into the intervention and control group.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria is scoring below 24 on the MMSE, not having a diagnosis of PD participating in another psychotherapy or intervention and below the age of 18 years old.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randominsation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The research design for this study is a randomised experimental design (waitlist control) with three repeated measures (pre-intervention, post-intervention and 3 month follow-up). The research design consists of one within-subject factor: Time (Pretest, posttest, 3-month follow-up) and one between-subjects factor: Group (Intervention, waitlist control). It belongs to a category of designs traditionally referred to as pretest-posttest control group designs with random allocation to groups. The participants will be randomly assigned to either experimental group (MBCT) or to the waitlist control group (CG). Once the data has been collected for the intervention group, the control group will be offered the MBCT treatment program. Outcome variables are depression, anxiety, mindfulness and quality of life.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A priori power analysis showed that a total of 40 participants (20 control, 20 intervention) would give 80% power to detect a large-sized difference (effect size = 0.8) with a = .05.

Data will be screened for outliers, missing data and checked for normality, linearity, homogeneity of variance-covariance matrices multicollinearity. Univariate outliers will be examined via box plots. If univariate outliers are identified their influence can be reduced by rescoring the participant data one standard deviation above the next most extreme score. If there is any missing data this will be dealt with accordingly where Expectation-Maximisation is recommended (Tabachnick & Fidell, 2001). Assumptions of Multilevel Modeling (MLM) are that the dependent variables are normally distributed, that the growth curve parameters are normally distributed where all participants show the same relationship overtime and observed changes are related to time and the growth curve and errors are independent and normally distributed (Rasbash, Steele, Browne, & Prosser, 2004).
It is predicted that a significant Time (pretest, posttest, and follow-up) by Group (Intervention and Waiting List) interaction exists across the clinical outcomes (symptoms of anxiety and depression, QOL and mindfulness). To explore whether the each outcome differs as a function of group across time, a multi-level mixed effects linear regression (MLM) will be conducted. By using MLM, the three time point measurements (pretest, posttest, and follow-up) can be identified as nested within individuals, where individuals are treated as a level 2 variable. The lower level analysis will then look at the effect of time on the dependent variable (symptoms of anxiety, depression, QOL, and mindfulness). In the present study, there are two fixed factors (Group, Time) and one random factor (Participants) with Time nested within participants.
Amongst particular therapy groups participants might interact in a certain way which could influence their scores on outcome variables, hence violating the assumption of independence. If this assumption has been violated within groups then this can be controlled for through a sandwich estimator for the standard errors (Rabe-Hesketh & Skrondal, 2005).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/03/2014
Actual
Date of last participant enrolment
Anticipated
30/04/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 7865 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 288881 0
University
Name [1] 288881 0
Curtin University
Country [1] 288881 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 287574 0
None
Name [1] 287574 0
Address [1] 287574 0
Country [1] 287574 0
Other collaborator category [1] 277867 0
University
Name [1] 277867 0
University of Queensland
Address [1] 277867 0
The University of Queensland, Sir Fred Schonell Dr, St Lucia QLD 4072
Country [1] 277867 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290710 0
Human Research Ethics Committee
Ethics committee address [1] 290710 0
Curtin University
Kent Street,
Bentley,
WA 6102
Ethics committee country [1] 290710 0
Australia
Date submitted for ethics approval [1] 290710 0
24/01/2014
Approval date [1] 290710 0
18/03/2014
Ethics approval number [1] 290710 0
HR32/2014

Summary
Brief summary
The aim is to evaluate the effectiveness of mindfulness for anxiety and depression in a sample of people with Parkinson's disease. The aim is to establish whether mindfulness is successful in reducing the impact of the depressive and anxiety symptoms while improving quality of life. It is expected that, compared to a wait-list control group, mindfulness participants will demonstrate significant improvements in depression, anxiety, mindfulness, and quality of life at post-intervention and at 3 month follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46906 0
Dr Rebecca Anderson
Address 46906 0
Curtin University
School of Psychology and Speech Pathology
Kent Street, Bentley WA 6102
Country 46906 0
Australia
Phone 46906 0
+61 08 9266 3012
Fax 46906 0
Email 46906 0
[email protected]
Contact person for public queries
Name 46907 0
Miss Sephora D'mello
Address 46907 0
Curtin University
School of Psychology and Speech Pathology
Kent Street, Bentley WA 6102
Country 46907 0
Australia
Phone 46907 0
+61 08 9266 3436
Fax 46907 0
Email 46907 0
[email protected]
Contact person for scientific queries
Name 46908 0
Miss Sephora D'mello
Address 46908 0
Curtin University
School of Psychology and Speech Pathology
Kent Street, Bentley WA 6102
Country 46908 0
Australia
Phone 46908 0
+61 08 9266 3436
Fax 46908 0
Email 46908 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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