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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
Scientific title
Investigating Mindfulness Therapy for Improving Movement and Psychological Symptoms in Parkinson's Disease
Secondary ID [1] 312843 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 334961 0
Anxiety 334962 0
Tremor 334963 0
Motor impairments 334964 0
Rigidity 334965 0
Bradykinesia 334966 0
Parkinson's disease 335125 0
Condition category
Condition code
Neurological 331490 331490 0 0
Parkinson's disease
Mental Health 331625 331625 0 0
Depression
Mental Health 331626 331626 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329390 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 339234 0
motor functioning
Timepoint [1] 339234 0
Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
Primary outcome [2] 339235 0
Tremor
Timepoint [2] 339235 0
Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
Primary outcome [3] 339238 0
Gait
Timepoint [3] 339238 0
Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
Secondary outcome [1] 439183 0
Depression symptoms
Timepoint [1] 439183 0
Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
Secondary outcome [2] 439186 0
Anxiety symptoms
Timepoint [2] 439186 0
Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
Secondary outcome [3] 439189 0
Mindfulness
Timepoint [3] 439189 0
Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
Secondary outcome [4] 439191 0
Depression symptoms in the context of patient
Timepoint [4] 439191 0
Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
Secondary outcome [5] 439194 0
Resting-state brain activity
Timepoint [5] 439194 0
Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
Secondary outcome [6] 439196 0
Resting-state heart rate variability
Timepoint [6] 439196 0
Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)
Secondary outcome [7] 439198 0
Motor functioning
Timepoint [7] 439198 0
Baseline, midpoint (at 4th week of intervention), and post (after 8 weeks of intervention)

Eligibility
Key inclusion criteria
A diagnosis of idiopathic Parkinson's disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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),

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
26/01/2026
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 317284 0
University
Name [1] 317284 0
Murdoch University
Country [1] 317284 0
Australia
Primary sponsor type
Individual
Name
Jane Tan, Murdoch University
Address
Country
Australia
Secondary sponsor category [1] 319567 0
None
Name [1] 319567 0
Address [1] 319567 0
Country [1] 319567 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316021 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 316021 0
http://our.murdoch.edu.au/Research-Ethics-and-Integrity/Human-research-ethics
Ethics committee country [1] 316021 0
Australia
Date submitted for ethics approval [1] 316021 0
25/06/2024
Approval date [1] 316021 0
Ethics approval number [1] 316021 0

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136534 0
A/Prof Ann-Maree Vallence
Address 136534 0
Murdoch University, 90 South Street, Murdoch WA 6150
Country 136534 0
Australia
Phone 136534 0
+61 08 93607464
Fax 136534 0
Email 136534 0
[email protected]
Contact person for public queries
Name 136535 0
Jane Tan
Address 136535 0
Murdoch University, 90 South Street Murdoch WA 6150
Country 136535 0
Australia
Phone 136535 0
+61 0422426329
Fax 136535 0
Email 136535 0
[email protected]
Contact person for scientific queries
Name 136536 0
Jane Tan
Address 136536 0
Murdoch University, 90 South Street Murdoch WA 6150
Country 136536 0
Australia
Phone 136536 0
+61 0422426329
Fax 136536 0
Email 136536 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


What supporting documents are/will be available?




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.