Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000485639
Ethics application status
Approved
Date submitted
23/02/2023
Date registered
12/05/2023
Date last updated
12/05/2023
Date data sharing statement initially provided
12/05/2023
Date results information initially provided
12/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mechanisms of mindfulness: A longitudinal observational study of the effects of Mindfulness-based Stress Reduction (MBSR) on depression, anxiety, and stress among participants in a MBSR program
Scientific title
Mechanisms of mindfulness: A longitudinal observational study of the effects of Mindfulness-based Stress Reduction (MBSR) on depression, anxiety, and stress among participants in a MBSR program
Secondary ID [1] 309009 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 329051 0
Anxiety 329052 0
Condition category
Condition code
Mental Health 326033 326033 0 0
Depression
Mental Health 326038 326038 0 0
Anxiety

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The intervention was an 8-week Mindfulness-based stress reduction (MBSR) course conducted by Openground Training. The course involved mindfulness meditation and body awareness training via 2.5-hour group classes conducted weekly. Participants for the study were recruited after enrollment in the course, such that students could attend the course irrespective of their decision to participate in the study. As such, this was an observational study of MBSR course enrollees.


Questionnaires were completed by participants at four time points: (1) before commencing the course; (2) mid-course, following attendance in week four; (3) end-of-course, following attendance in week eight; and (4) three months after course completion (approximately 20 weeks in total). These questionnaires were the Five Facet Mindfulness Questionnaire (FFMQ), the Toronto Mindfulness Scale-Trait Version (TMS-T), the Self-Compassion Scale (SCS), and the Depression Anxiety and Stress Scale - Short Form (DASS-21). The questionnaire responses were initially collected in pen and paper format, but following the first term of groups, procedures were changed to an online survey in order to streamline the data collection. Questionnaires would take approximately 15-30 minutes to complete.
Intervention code [1] 325456 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333898 0
Depression assessed by the Depression Anxiety Stress Scale – Short form (DASS-21)
Timepoint [1] 333898 0
Week 0 (start of course), Week 4 (mid-course), Week 8 (end of course), 3-month follow-up (post-course)
Primary outcome [2] 334261 0
Anxiety assessed by the Depression Anxiety Stress Scale – Short form (DASS-21)
Timepoint [2] 334261 0
Week 0 (start of course), Week 4 (mid-course), Week 8 (end of course), 3-month follow-up (post-course)
Primary outcome [3] 334262 0
Stress assessed by the Depression Anxiety Stress Scale – Short form (DASS-21)
Timepoint [3] 334262 0
Week 0 (start of course), Week 4 (mid-course), Week 8 (end of course), 3-month follow-up (post-course)
Secondary outcome [1] 418654 0
Mindfulness Facet of Nonreactivity was assessed with the Five Facet Mindfulness Questionnaire (FFMQ)
Timepoint [1] 418654 0
Week 0 (start of course), Week 4 (mid-course), Week 8 (end of course), 3-month follow-up (post-course)
Secondary outcome [2] 420040 0
Trait Mindfulness facet of Curiosity was assessed with the Toronto Mindfulness Scale - Trait Version (TMS-T)
Timepoint [2] 420040 0
Week 0 (start of course), Week 4 (mid-course), Week 8 (end of course), 3-month follow-up (post-course)
Secondary outcome [3] 420041 0
Self-compassion was assessed with the Self-compassion Scale (SCS)
Timepoint [3] 420041 0
Week 0 (start of course), Week 4 (mid-course), Week 8 (end of course), 3-month follow-up (post-course)
Secondary outcome [4] 420042 0
Mindfulness Facet of Observing were assessed with the Five Facet Mindfulness Questionnaire (FFMQ)
Timepoint [4] 420042 0
Week 0 (start of course), Week 4 (mid-course), Week 8 (end of course), 3-month follow-up (post-course)
Secondary outcome [5] 420043 0
Mindfulness Facet of Acting with Awareness was assessed with the Five Facet Mindfulness Questionnaire (FFMQ)
Timepoint [5] 420043 0
Week 0 (start of course), Week 4 (mid-course), Week 8 (end of course), 3-month follow-up (post-course)
Secondary outcome [6] 420044 0
Mindfulness Facet of Describing was assessed with the Five Facet Mindfulness Questionnaire (FFMQ)
Timepoint [6] 420044 0
Week 0 (start of course), Week 4 (mid-course), Week 8 (end of course), 3-month follow-up (post-course)
Secondary outcome [7] 420045 0
Mindfulness Facets of Nonjudging was assessed with the Five Facet Mindfulness Questionnaire (FFMQ)
Timepoint [7] 420045 0
Week 0 (start of course), Week 4 (mid-course), Week 8 (end of course), 3-month follow-up (post-course)
Secondary outcome [8] 420046 0
Trait Mindfulness facets of Decentering was assessed with the Toronto Mindfulness Scale - Trait Version (TMS-T)
Timepoint [8] 420046 0
Week 0 (start of course), Week 4 (mid-course), Week 8 (end of course), 3-month follow-up (post-course)

Eligibility
Key inclusion criteria
Must have been enrolled in MBSR courses conducted by Openground Training and Consultation in Sydney, Melbourne and Brisbane, Australia
Minimum age
21 Years
Maximum age
67 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
N/A

Study design
Purpose
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Structural Equation Modeling/Path Analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/04/2009
Date of last participant enrolment
Anticipated
Actual
2/05/2010
Date of last data collection
Anticipated
Actual
12/10/2010
Sample size
Target
360
Accrual to date
Final
226
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 313222 0
Government body
Name [1] 313222 0
Commonwealth Government of Australia
Country [1] 313222 0
Australia
Primary sponsor type
University
Name
Psychology Department at Macquarie University
Address
.16 University Ave, Macquarie University, NSW 2109, Australia
Country
Australia
Secondary sponsor category [1] 314943 0
Other
Name [1] 314943 0
OpenGround Training
Address [1] 314943 0
openground.com.au
Country [1] 314943 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312452 0
Macquarie University Ethics Approval Committee for Human Research
Ethics committee address [1] 312452 0
4–6 Eastern Road, Macquarie University NSW 2109 Australia
Ethics committee country [1] 312452 0
Australia
Date submitted for ethics approval [1] 312452 0
Approval date [1] 312452 0
26/09/2008
Ethics approval number [1] 312452 0

Summary
Brief summary
This study aimed to identify MBSR-related changes in depression, anxiety, and stress and various subcomponents of mindfulness using a longitudinal design over an 8-week MBSR course.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124718 0
Dr Karen Davis
Address 124718 0
Basten & Associates, Clinical Psychologists
PO Box 383
Westmead NSW 2145
Australia
Country 124718 0
Australia
Phone 124718 0
+61 0413 012 700
Fax 124718 0
Email 124718 0
karen.davis.psychologist@gmail.com
Contact person for public queries
Name 124719 0
Mr Curtis Wojcik
Address 124719 0
University of Maine
Department of Psychology
324 Beryl Warner Williams Hall
Orono, ME 04469
Country 124719 0
United States of America
Phone 124719 0
+12079774288
Fax 124719 0
Email 124719 0
curtis.wojcik@maine.edu
Contact person for scientific queries
Name 124720 0
Mr Curtis Wojcik
Address 124720 0
University of Maine
Department of Psychology
324 Beryl Warner Williams Hall
Orono, ME 04469
Country 124720 0
United States of America
Phone 124720 0
+12079774288
Fax 124720 0
Email 124720 0
curtis.wojcik@maine.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.