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Trial registered on ANZCTR
Registration number
ACTRN12624001169538p
Ethics application status
Submitted, not yet approved
Date submitted
29/08/2024
Date registered
25/09/2024
Date last updated
13/10/2024
Date data sharing statement initially provided
25/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Investigating Mindfulness Therapy for Movement and Psychological Symptoms in Parkinson's
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Scientific title
Investigating Mindfulness Therapy for Improving Movement and Psychological Symptoms in Parkinson's Disease
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Secondary ID [1]
312843
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depression
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Anxiety
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Tremor
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Motor impairments
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Rigidity
334965
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Bradykinesia
334966
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Parkinson's disease
335125
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Condition category
Condition code
Neurological
331490
331490
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0
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Parkinson's disease
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Mental Health
331625
331625
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0
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Depression
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Mental Health
331626
331626
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a an 8-week mindfulness program for reducing movement symptoms and psychological distress in individuals with Parkinson's disease:
8-week duration; 10-min app-based sessions 5 days a week, 40-min online group meditation session once a week, 50-min consultation and group meditation session once a month. All of the sessions will involve guided mindfulness exercises that cover the five key concepts of mindfulness: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. The weekly and monthly group sessions will be held via Zoom by experienced mindfulness mentors. Both weekly and month sessions will involve a group mindfulness exercise. During the monthly sessions, participants are given the opportunity to ask the mentors any questions that they might have about mindfulness practice.
During mindfulness exercise, participants will be asked to observe and be aware of their physical sensations, breathing, emotions, thoughts, and environment. Participants will be asked to make these observations without judgment, i.e., to simply notice and focus on their current sensations, thoughts and feelings. An example script of a mindfulness session has been attached.
Adherence to the intervention will be measured through the app usage of the participants.
An 'alternate allocation' approach will be taken: participants are allocated first to either the Intervention group or Waitlist control group on a reciprocal basis until all 72 patients have been allocated.
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Intervention code [1]
329390
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Treatment: Other
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Comparator / control treatment
Waitlist control: Participants will not receive any intervention over an 8-week period. They will be provided the opportunity to receive the mindfulness intervention program after the 8-week period.
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Control group
Active
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Outcomes
Primary outcome [1]
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motor functioning
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Assessment method [1]
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The Movement Disorder Society-Sponsored Revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).
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Timepoint [1]
339234
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Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
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Primary outcome [2]
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Tremor
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Assessment method [2]
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Physiological recordings of tremor will be measured using a tri-axial accelerometer placed on the hand and electromyographic activity recorded from hand and forearm muscles.
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Timepoint [2]
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Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
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Primary outcome [3]
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Gait
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Assessment method [3]
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10-metre walk on a GAITRite electronic walkway system
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Timepoint [3]
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Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
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Secondary outcome [1]
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Depression symptoms
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Assessment method [1]
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Depression Anxiety Stress Scales – 21 (DASS-21)
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Timepoint [1]
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Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
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Secondary outcome [2]
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Anxiety symptoms
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Assessment method [2]
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Depression Anxiety Stress Scales – 21 (DASS-21)
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Timepoint [2]
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Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
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Secondary outcome [3]
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Mindfulness
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Assessment method [3]
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Five Facet Mindfulness Questionnaire (FFMQ-39)
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Timepoint [3]
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Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
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Secondary outcome [4]
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Depression symptoms in the context of patient
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Assessment method [4]
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Patient Health Questionnaire (PHQ-9)
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Timepoint [4]
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Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
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Secondary outcome [5]
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Resting-state brain activity
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Assessment method [5]
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Electroencephalography (EEG)
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Timepoint [5]
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Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
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Secondary outcome [6]
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Resting-state heart rate variability
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Assessment method [6]
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Actiheart (CamNTech) ECG recorder
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Timepoint [6]
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Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
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Secondary outcome [7]
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Motor functioning
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Assessment method [7]
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Inertial measurement units will be worn on trunk and limbs for movement measurement.
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Timepoint [7]
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Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
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Eligibility
Key inclusion criteria
A diagnosis of idiopathic Parkinson's disease
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Potential cognitive impairment (screened using the Montreal Cognitive Assessment questionnaire); history of mania, psychosis, or substance use preventing engagement; experienced mindfulness practitioners (i.e., practiced mindfulness more than twice a week for the past 12 months),
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/11/2024
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Actual
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Date of last participant enrolment
Anticipated
1/12/2025
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Actual
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Date of last data collection
Anticipated
26/01/2026
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Actual
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Sample size
Target
72
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Murdoch University
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Address [1]
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Country [1]
317284
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Australia
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Primary sponsor type
Individual
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Name
Jane Tan, Murdoch University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
319567
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Address [1]
319567
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Country [1]
319567
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Murdoch University Human Research Ethics Committee
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Ethics committee address [1]
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http://our.murdoch.edu.au/Research-Ethics-and-Integrity/Human-research-ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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25/06/2024
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Approval date [1]
316021
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Ethics approval number [1]
316021
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Summary
Brief summary
This project aims to examine the effectiveness and biological (physiological) mechanisms of an 8-week app-based mindfulness program for reducing movement symptoms and psychological distress in individuals with Parkinson's disease. We hypothesised that there will be improvements in movement symptoms and reductions in psychological distress for participants after the 8-week intervention. We also hypothesize that there will be corresponding changes in EEG activity in brain regions typically associated with emotion regulation and mindfulness ability. We also expect increases in resting-state heart rate variability, which are thought to reflect improvements in emotion regulation and previously found to be increased by mindfulness-based interventions
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Ann-Maree Vallence
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Address
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Murdoch University, 90 South Street, Murdoch WA 6150
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Country
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Australia
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Phone
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+61 08 93607464
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Jane Tan
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Address
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Murdoch University, 90 South Street Murdoch WA 6150
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Country
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Australia
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Phone
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+61 0422426329
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Fax
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Email
136535
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[email protected]
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Contact person for scientific queries
Name
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Jane Tan
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Address
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Murdoch University, 90 South Street Murdoch WA 6150
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Country
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Australia
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Phone
136536
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+61 0422426329
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Fax
136536
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Email
136536
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Mainly to protect participant privacy - even though all data will be de-identified, previous participants have indicated that they are unsure about having their individual data available to individuals external to our research team.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24141
Informed consent form
388369-(Uploaded-29-08-2024-12-02-55)-Att Consent form ANZCTR.docx
24207
Other
Example script of mindfulness exercise
388369-(Uploaded-18-09-2024-15-47-06)-Example Script of Mindfulness Exercise.docx
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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