Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000422123
Ethics application status
Approved
Date submitted
27/02/2019
Date registered
14/03/2019
Date last updated
10/12/2021
Date data sharing statement initially provided
14/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mindfulness-Based Cognitive Therapy (MBCT) Meditation Type and Time: Impact on Well-being
Scientific title
Impact of MBCT sitting meditation vs. mindful movement for different durations on adults' well-being
Secondary ID [1] 297542 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Well-being 311755 0
Condition category
Condition code
Mental Health 310381 310381 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
People can practice mindfulness using different techniques and for different amounts of time. In this study, we compare the impact of two core meditation practices from Mindfulness-Based Cognitive Therapy - MBCT - (sitting practice versus mindful movement) and different time lengths (10 minutes versus 30 minutes) on well-being. Four practices will thus be used and participants will be randomly allocated to one of these meditations and asked to practice daily for two weeks.

Short sitting practice: Instructions invite participants to focus on the breath and the body, before simply resting in awareness itself. Long sitting practice: Instructions invite participants to focus on the breath, the body, sounds, thoughts and feelings. Short mindful movement: Involves a sequence of simple standing stretches bringing body sensations into focus during each movement, allowing participants to explore sensations of the body in movement and stillness, and how the body has limits that can be respected without judgement and self-criticism. Long mindful movement: Involves simple stretches starting from a lying posture, allowing participants to explore sensations of the body in movement and stillness, and how the body has limits that can be respected without judgement and self-criticism.

All the meditations are administered through a secret Soundcloud URL link - and are led and guided by Professor Mark Williams, co-founder of MBCT and Founding Director of the Oxford Mindfulness Centre (OMC). The shorter mindful movement meditation is from the SoundCloud profile for Mark Williams' book Mindfulness: A practical guide to finding peace in a frantic world. The remaining three meditations are from the OMC's MBCT website: https://mbctapp.oxfordmindfulness.org/. These are all used with Mark Williams and the OMC's permission.

The Qualtrics platform monitors participants completion of the well-being surveys. Email reminders are also sent out to participants through the Qualtrics platform.
Intervention code [1] 313776 0
Treatment: Other
Comparator / control treatment
Group 1 & 2 are essentially receiving the same intervention but in different doses.
Group 3 & 4 are essentially receiving the same intervention but in different doses.

Group 1. Sitting Meditation Practice – 10 minutes per day, for two weeks. (Comparator)
Group 2. Sitting Meditation Practice – 30 minutes per day, for two weeks. 
Group 3. Mindful Movement – 10 minutes per day, for two weeks. (Comparator)
Group 4. Mindful Movement – 30 minutes per day, for two weeks.
Control group
Dose comparison

Outcomes
Primary outcome [1] 319259 0
Change in score on Warwick-Edinburgh Mental Well-Being (WEMWBS) scale.
Timepoint [1] 319259 0
Baseline, before intervention (pre-intervention), and after 2 weeks of intervention (post-intervention).
Secondary outcome [1] 367489 0
Change in score on Mindful Attention Awareness Scale (MAAS).
Timepoint [1] 367489 0
Baseline, before intervention (pre-intervention), and after 2 weeks of intervention (post-intervention).
Secondary outcome [2] 404074 0
Change in score on General Population - Clinical Outcomes in Routine Evaluation (GP-CORE) scale.
Timepoint [2] 404074 0
Baseline, before intervention (pre-intervention), and after 2 weeks of intervention (post-intervention).

Eligibility
Key inclusion criteria
Participants should be 18+ years of age, living in the UK, and fluent in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People currently experiencing low mood, any active mental health crises, untreated mental conditions or recent major adverse life events are advised not to participate in the study, as mindfulness meditation could increase the psychological distress.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation done by Qualtrics.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation done by Qualtrics.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/02/2019
Date of last participant enrolment
Anticipated
30/07/2021
Actual
17/05/2021
Date of last data collection
Anticipated
30/09/2021
Actual
6/06/2021
Sample size
Target
126
Accrual to date
Final
169
Recruitment outside Australia
Country [1] 21316 0
United Kingdom
State/province [1] 21316 0

Funding & Sponsors
Funding source category [1] 302100 0
University
Name [1] 302100 0
School of Psychology and Neuroscience - University of St Andrews
Country [1] 302100 0
United Kingdom
Primary sponsor type
University
Name
School of Psychology and Neuroscience - University of St Andrews,
Address
School of Psychology and Neuroscience,
University of St Andrews,
St Mary's Quad,
South St,
St Andrews
KY16 9JP
Country
United Kingdom
Secondary sponsor category [1] 301928 0
None
Name [1] 301928 0
Address [1] 301928 0
Country [1] 301928 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302778 0
University Teaching and Research Ethics Committee (UTREC) - St Andrews
Ethics committee address [1] 302778 0
Ethics committee country [1] 302778 0
United Kingdom
Date submitted for ethics approval [1] 302778 0
22/11/2018
Approval date [1] 302778 0
10/01/2019
Ethics approval number [1] 302778 0
PS14025

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91370 0
Mr Guy William Fincham
Address 91370 0
School of Psychology and Neuroscience - University of St Andrews,
St Mary's Quad,
South St,
St Andrews,
KY16 9JP,
United Kingdom
Country 91370 0
United Kingdom
Phone 91370 0
+447565983253
Fax 91370 0
Email 91370 0
[email protected]
Contact person for public queries
Name 91371 0
Guy William Fincham
Address 91371 0
School of Psychology and Neuroscience - University of St Andrews,
St Mary's Quad,
South St,
St Andrews,
KY16 9JP,
United Kingdom
Country 91371 0
United Kingdom
Phone 91371 0
+447565983253
Fax 91371 0
Email 91371 0
[email protected]
Contact person for scientific queries
Name 91372 0
Guy William Fincham
Address 91372 0
School of Psychology and Neuroscience - University of St Andrews,
St Mary's Quad,
South St,
St Andrews,
KY16 9JP,
United Kingdom
Country 91372 0
United Kingdom
Phone 91372 0
+447565983253
Fax 91372 0
Email 91372 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
Published data will be fully anonymous.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1467Ethical approval    377078-(Uploaded-27-02-2019-02-03-14)-Study-related document.pdf



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.