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Trial registered on ANZCTR


Trial ID
ACTRN12612000440820
Ethics application status
Approved
Date submitted
17/04/2012
Date registered
18/04/2012
Date last updated
18/12/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The Essence of managing Parkinson’s disease: The impact of a mindfulness based lifestyle program for people with Parkinson’s disease
Scientific title
The effect of an intervention – ESSENCE - involving a mindfulness based lifestyle program on symptoms in adults with disability congruent with stage 2 (Hoehn and Yahr staging) Parkinson’s disease: a randomised two-group concurrent control, before and after, study
Secondary ID [1] 280338 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage 2 (Hoehn and Yahr staging) Parkinsons disease 286297 0
Mental health 286298 0
Condition category
Condition code
Neurological 286564 286564 0 0
Parkinson's disease
Mental Health 286565 286565 0 0
Depression
Alternative and Complementary Medicine 286566 286566 0 0
Spiritual care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, called the Essence program, is undertaken by participants over six weeks – i.e. one 90 minute session per week for six weeks.

The Essence program is a mindfulness and lifestyle course developed and delivered by Dr Craig Hassed from Monash University. ‘Essence’ stands for Education, Stress management, Spirituality (meaning), Exercise, Nutrition, Connectedness (social support) and Environment.

The short course will explore the potential role each of these elements has in managing Parkinson’s and improving quality of life. The program will introduce participants to simple strategies that can help them to live well with Parkinson’s disease and they will be encouraged, but not pressured, to apply aspects of the Essence model that are most relevant to their own lives.

Sessions will be run in groups of 20-30, and will be held in metropolitan Melbourne.
Intervention code [1] 284693 0
Lifestyle
Intervention code [2] 284694 0
Behaviour
Comparator / control treatment
This pilot study is a prospective mixed-methods before and after study using a ‘no treatment’ wait list control. The second group will effectively act as the pseudo control group. The second group will also receive the intervention but at a later stage i.e. ten weeks after recruitment and after group one has completed the intervention.
Control group
Active

Outcomes
Primary outcome [1] 286970 0
Primary Outcome 1: symptoms of Parkinsons disease as measured by the Function and well being associated with Parkinsons disease questionnaire (PDQ39).
Timepoint [1] 286970 0
Timepoint: at baseline and at 6, and 26 weeks after intervention commencement
Primary outcome [2] 286971 0
Primary Outcome 2: Mental health questionnaire DASS-21 score
Timepoint [2] 286971 0
Timepoint: at baseline and at 6, and 26 weeks after intervention commencement
Secondary outcome [1] 297072 0
Secondary Outcome 1: Mindfulness lifestyle as assessed using a Freiburg Mindfulness Inventory
Timepoint [1] 297072 0
Timepoint: at baseline and at 6, and 26 weeks after intervention commencement
Secondary outcome [2] 297073 0
Secondary Outcome 2: Health beliefs as assessed using a Multidimensional Health Locus of Control (MHLC) Scale Form B
Timepoint [2] 297073 0
Timepoint: at baseline and at 6, and 26 weeks after intervention commencement
Secondary outcome [3] 297074 0
Secondary Outcome 3: Health behaviours as assessed using a Health Behaviours Questionnaire
Timepoint [3] 297074 0
Timepoint: at baseline and at 6, and 26 weeks after intervention commencement

Eligibility
Key inclusion criteria
Eligibility criteria require that all volunteer participants:
* Are 70 years old or younger
* Are fluent in English
* Can attend at least 4 of 6 sessions of a the mindfulness based lifestyle program
* Are community living adults with disability congruent with stage 2 Parkinson’s disease (Hoehn and Yahr staging) i.e. can answer ‘yes’ to the two following questions
** Do you have problems of shaking (tremor), stiffness or difficulty with movements on both sides of your body?
** Most of the time you can you walk straight and stand up without assistance? (i.e. not severe)
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Excluded if they cannot commit to attending at least 4 of 6 sessions of a the mindfulness based lifestyle program

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The method of allocation concealment will be done by the recruiting officer (BV) contacting the holder of the allocation schedule who is “off-site” at the central administration site (JH).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Because this is a small pilot study, the permuted block method of randomisation will be used. A random-event generator (www.randomizer.org) will be employed. The randomised allocation code will be kept “off-site” at the central administration site (JH).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A 2-group clinical trial, with a wait-list control.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)

Funding & Sponsors
Funding source category [1] 285112 0
Charities/Societies/Foundations
Name [1] 285112 0
Parkinsons Victoria
Address [1] 285112 0
8b Park Road Cheltenham VIC 3192
Country [1] 285112 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Southern Academic Primary Care Research Unit
Address
Monash University, 314B Thomas Street Dandenong, Victoria, Australia 3175.
Country
Australia
Secondary sponsor category [1] 283969 0
None
Name [1] 283969 0
Address [1] 283969 0
Country [1] 283969 0
Other collaborator category [1] 260740 0
Individual
Name [1] 260740 0
Dr Craig Hassed
Address [1] 260740 0
Monash University Department of General Practice, Building 1, 270 Ferntree Gully Road, Notting Hill, 3168 Victoria, Australia
Country [1] 260740 0
Australia
Other collaborator category [2] 260741 0
Individual
Name [2] 260741 0
Dr Joanne Enticott
Address [2] 260741 0
Monash University, Southern Academic Primary Care Research Unit, 314B Thomas Street Dandenong, Victoria, Australia 3175
Country [2] 260741 0
Australia
Other collaborator category [3] 260742 0
Individual
Name [3] 260742 0
Ms Jennifer Hester
Address [3] 260742 0
Monash University, School of Primary Health Care , Building 1, 270 Ferntree Gully Road, Notting Hill, 3168, Victoria, Australia
Country [3] 260742 0
Australia
Other collaborator category [4] 260756 0
Individual
Name [4] 260756 0
Dr Grant Russell
Address [4] 260756 0
Monash University, Southern Academic Primary Care Research Unit, 314B Thomas Street Dandenong, Victoria, Australia 3175
Country [4] 260756 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287123 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 287123 0
Monash University Clayton campus. Wellington Road Clayton Victoria 3800
Ethics committee country [1] 287123 0
Australia
Date submitted for ethics approval [1] 287123 0
Approval date [1] 287123 0
23/02/2012
Ethics approval number [1] 287123 0
CF11/2662 2011001553

Summary
Brief summary
We aim to conduct a mixed methods evaluation of the impact on patients of a 6 week mindfulness and Essence based lifestyle program with community living adults with disability congruent with stage 2 (Hoehn and Yahr staging) Parkinson’s Disease.
Quantitative study aims. To determine whether:
1. Participation in a 6 week mindfulness and Essence based lifestyle program improves PD disease related function in patients with disability consistent with stage 2 Parkinson’s disease?

2. In these patients, does the Essence program influence patient a) health beliefs; b) mental and emotional health; c) health locus of control?
Qualitative study aims. To better understand:
3. What are the experiences of patients with PD attending the mindfulness based intervention?
4. Beliefs about disease management before and after the program?
5. How attitudes towards their health efficacy evolve over the course of the program?
6. What aspects of the program were most valuable and meaningful?
7. How people engaged with the program?
Trial website
http://sapcru.org/projects/parkinson%e2%80%99s-disease/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34070 0
Address 34070 0
Country 34070 0
Phone 34070 0
Fax 34070 0
Email 34070 0
Contact person for public queries
Name 17317 0
BREANNA WOTHERSPOON
Address 17317 0
PARKINSON'S VICTORIA, PO Box 2606 Cheltenham VIC 3192
Country 17317 0
Australia
Phone 17317 0
+61 (3) 9581 8700
Fax 17317 0
+61 (3) 9583 9952
Email 17317 0
breanna@parkinsons-vic.org.au
Contact person for scientific queries
Name 8245 0
Dr Joanne Enticott
Address 8245 0
Southern Academic Primary Care Research Unit (SAPCRU), 314b Thomas Street, Dandenong, Victoria, Australia, 3175
Country 8245 0
Australia
Phone 8245 0
+61 3 9902 4899
Fax 8245 0
Email 8245 0
joanne.enticott@monash.edu