Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001043921
Ethics application status
Approved
Date submitted
4/02/2020
Date registered
14/10/2020
Date last updated
29/10/2021
Date data sharing statement initially provided
14/10/2020
Date results information initially provided
29/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of a Mindfulness and Goal Setting Quality of Life Program and Questionnaire
Scientific title
An evaluation of a Mindfulness and Goal Setting Quality of Life Program and Questionnaire in healthy volunteers
Secondary ID [1] 300277 0
'Nil known'
Universal Trial Number (UTN)
U1111-1246-9429
Trial acronym
MQW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Well-being 315857 0
Quality of life 315858 0
Mindfulness 315913 0
Condition category
Condition code
Mental Health 314137 314137 0 0
Anxiety
Mental Health 316611 316611 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: An evaluation of a Mindfulness and Goal Setting Quality of Life Program and Questionnaire
Differences between the two intervention conditions: Condition 1 is a 2-day version of the mindfulness training section of the previously tested Mindfulness-based Quality of Life and Well-Being Program whilst Condition 2 is the full 2-day Mindfulness-based Quality of Life and Well-Being Program which teaches mindfulness and goal setting.
Description:
Materials: Handouts the handouts were designed specifically for this study and will be given for each section of the program.
Content and Tasks: The course will be delivered in a 2 hour lecture format. It will include theory and exercises including mindfulness training and practice and filling out a written quality of life plan.
Delivery: the program will be delivered by a mindfulness trainer with a minimum of 5 years' experience.
Mode of delivery - it will be provided in a group.
Size of groups: the approximate size of each of the 2 conditions will be 30 - 60 participants each, split into 2 groups of approx. 15 - 30 each.
Number of times the intervention will be delivered: both versions (2) of the program will be delivered two times, once per week for 6 weeks (2 hr training seminars)
Monitoring intervention compliance: strategies used to monitor adherence to the intervention will include weekly homework diaries and follow up email/phone call if 2/6 classes are missed.
Location - the intervention will be delivered at Atwell Community Centre.
Intervention code [1] 316595 0
Treatment: Other
Comparator / control treatment
Mindfulness training alone
Control group
Active

Outcomes
Primary outcome [1] 322579 0
Well-being and quality of life assessed by change on the Clinically-based Quality of Life Scale (CLINQOL).
Timepoint [1] 322579 0
Individuals will be given assessments at the beginning of the intervention (pre), at the end of the 6 week training (post- primary timepoint), and at 4 weeks (follow up).
Primary outcome [2] 324728 0
Well-being and quality of life assessed by change on the Satisfaction with Life Scale (SWLS).
Timepoint [2] 324728 0
Individuals will be given assessments at the beginning of the intervention (pre), at the end of the 6 week training (post- primary timepoint), and at 4 weeks (follow up).
Primary outcome [3] 324730 0
Well-being and quality of life assessed by change on the Personal Well-Being Index (PWI).
Timepoint [3] 324730 0
Individuals will be given assessments at the beginning of the intervention (pre), at the end of the 6 week training (post - primary timepoint), and at 4 weeks (follow up).
Secondary outcome [1] 379505 0
Mindfulness as assessed by change on the MAAS (Mindful Attention Awareness Scale).
Timepoint [1] 379505 0
Individuals will be given assessments at the beginning of the intervention (pre), at the end of the 6 week training (post), and at 4 weeks (follow up).
Secondary outcome [2] 385590 0
Mental health assessed by change on the DASS-21
Timepoint [2] 385590 0
Individuals will be given assessments at the beginning of the intervention (pre), at the end of the 6 week training (post), and at 4 weeks (follow up).

Eligibility
Key inclusion criteria
Healthy male or female subjects aged from 18 years old onwards.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People may not be eligible to participate if they are being treated for a major mental health disorder (for example bipolar disorder or schizophrenia).

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: We were unable to run a Power analysis to calculate the required sample size because this will be the first study to compare mindfulness treatment alone versus the combination of mindfulness treatment and goal setting. However, we will collect data from at least 60 participants in each experimental condition, to allow us to investigate major predictors of response to treatment within each group.
Analysis: The main analyses will evaluate the significance of change from pre-test to the post-test. Prior to conducting the analyses, outliers and normality of the variables will be examined, with the outlier labelling rule. A MANOVA will be conducted across two time points (pre and post) to examine the effect of treatment upon the dependent variables. For univariate effects planned contrasts (pre-post) will be run to clarify interactions and, if significant, t-tests will be conducted within each condition at pre versus post and between conditions at each time point. A reliability analysis will also be conducted to evaluate the test-retest reliability of the measurement scale from 4 weeks before the intervention to immediately before the intervention.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/09/2020
Date of last participant enrolment
Anticipated
19/10/2020
Actual
19/10/2020
Date of last data collection
Anticipated
3/12/2020
Actual
21/12/2020
Sample size
Target
150
Accrual to date
Final
74
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 31266 0
6164 - Success

Funding & Sponsors
Funding source category [1] 304701 0
Government body
Name [1] 304701 0
Cockburn Council
Country [1] 304701 0
Australia
Primary sponsor type
Individual
Name
Prof Peter Drummond
Address
Murdoch University
College of Science, Health, Engineering and Education
South Street MURDOCH,
WA, 6150
Country
Australia
Secondary sponsor category [1] 305012 0
Individual
Name [1] 305012 0
Patrick Jones
Address [1] 305012 0
Murdoch University
College of Science, Health, Engineering and Education
South Street MURDOCH,
WA, 6150
Country [1] 305012 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305119 0
Human Research Ethics Committee Murdoch University
Ethics committee address [1] 305119 0
Murdoch University
Research Ethics and Integrity
Chancellery Building
South Street MURDOCH WA 6150
Ethics committee country [1] 305119 0
Australia
Date submitted for ethics approval [1] 305119 0
27/11/2019
Approval date [1] 305119 0
30/01/2020
Ethics approval number [1] 305119 0
Murdoch Ethics Committee Project No: 2019/237

Summary
Brief summary
The purpose of the project is to compare the well-being effects of a mindfulness training program versus a mindfulness and goal setting program. Subjects will be randomly allocated to one of the two conditions and there will be a maximum of 60 people per course.

Condition 1 is a 2-day version of the mindfulness training section of the previously tested Mindfulness-based Quality of Life and Well-Being Program. Participants will be introduced to general mindfulness theory and principles before being taught techniques and exercises such as progressive muscle relaxation, neutral observation of the breath and present moment awareness.

Condition 2 is the full 2-day Mindfulness-based Quality of Life and Well-Being Program which teaches mindfulness and goal setting. In addition to 1 day of mindfulness training, participants will be trained for 1 day in the theory and methods of goal setting applied to major quality of life domains (relationships, work, money, health and leisure).

Individuals will be given assessments at the beginning and end of the 2-day workshops, and at 4 weeks follow up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99334 0
Prof Peter Drummond
Address 99334 0
College of Science, Health, Engineering and Education
Murdoch University
South Street MURDOCH,
WA, 6150
Country 99334 0
Australia
Phone 99334 0
+61 8 9360 2415
Fax 99334 0
Email 99334 0
[email protected]
Contact person for public queries
Name 99335 0
Mr Patrick Jones
Address 99335 0
College of Science, Health, Engineering and Education
Murdoch University
South Street MURDOCH,
WA, 6150
Country 99335 0
Australia
Phone 99335 0
+61 1300 70 50 55
Fax 99335 0
Email 99335 0
[email protected]
Contact person for scientific queries
Name 99336 0
Mr Patrick Jones
Address 99336 0
College of Science, Health, Engineering and Education
Murdoch University
South Street MURDOCH,
WA, 6150
Country 99336 0
Australia
Phone 99336 0
+61 1300 70 50 55
Fax 99336 0
Email 99336 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
Data will be anonymised and collated to be analysed as one group.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6507Informed consent form    379069-(Uploaded-04-02-2020-12-59-48)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 379069-(Uploaded-27-07-2021-19-14-03)-Basic results summary.docx
Plain language summaryNo Mindfulness-based Quality of Life and Well-Being P... [More Details]

Documents added automatically
No additional documents have been identified.