- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06402461
Comparing Random Allocation and Allocation by Preference to Mindfulness Practice
A Randomized Controlled Study Comparing the Effect of Preferential and Random Allocation to Type of Mindfulness Practice in the General Population.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will be an online administered experimental 3x2x3 design, with between-participant factor group (allocated to mindfulness practice based on preference vs. randomly allocated to mindfulness practice vs. audiobook control); a between-participant factor of practice type (mindfulness of the breath vs. mindfulness of sounds), which will be a dummy variable for the control group; and a within-participant factor of time (baseline vs. post-allocation vs. post-intervention). Participants in the 'preference group' will choose which of two mindfulness meditation practices (mindfulness of the breath or mindfulness of sounds) to undertake based on a brief description. Participants in the 'random allocation' group will be allocated to one of the two mindfulness practices at random, and participants in the control group will listen to an excerpt from an audiobook of an equivalent length of time. The primary outcome, state mindfulness, will be measured at all three time-points, as will positive and negative mood. Practice quality and intentional to engage in future mindfulness practice will be measured at post-intervention only.
The following hypotheses will be tested:
H1: Both the allocation by preference and random allocation groups will show greater improvement than the control group on both the primary outcome (baseline to post-intervention change in state mindfulness) and all the secondary outcomes, with the exception of practice quality (which is not applicable for the control group).
H2: The allocation by preference group will show better primary and secondary outcomes than the allocation by random group.
H3: The difference between each mindfulness-practice group and the control group in baseline to post-intervention improvement in mood state will be statistically mediated by baseline to post-intervention increase in state mindfulness.
H4:The difference between the allocation by preference and random allocation groups in baseline to post-intervention change in mood state will be serially, statistically mediated by practice quality and baseline to post-intervention change in state mindfulness respectively, such that participants allocated to the preference group will show higher practice quality, which in turn will statistically predict greater improvement in mindfulness, which in turn will statistically predict greater improvement in mood state.
H5: The same statistical mediation effects as described in H4 above will be observed when the outcome is self-reported intention to practice mindfulness in future, instead of mood state.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kent
-
Royal Tunbridge Wells, Kent, United Kingdom, TN1 2YG
- Salomons Institute for Applied Psychology, Canterbury Christ Church University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-Resident in the UK
Exclusion Criteria:
- Currently practicing mindfulness meditation more than once per week.
- Experiencing significant mental health problems.
- Believe that practicing mindfulness could cause significant distress.
- Previously practicing mindfulness has caused significant distress.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Allocation by preference
Participants are allocated to the one of the two mindfulness practices that they would prefer to do, based on a short description.
|
A 10 minute, audio guided, mindfulness of the breath meditation of the sort used in mindfulness-based cognitive therapy
A 10 minute, audio guided, mindfulness of sounds meditation of the sort used in mindfulness-based cognitive therapy
|
|
Experimental: Allocation by random
Participants are randomly allocated to one of the two mindfulness practices.
|
A 10 minute, audio guided, mindfulness of the breath meditation of the sort used in mindfulness-based cognitive therapy
A 10 minute, audio guided, mindfulness of sounds meditation of the sort used in mindfulness-based cognitive therapy
|
|
Active Comparator: Control
Participants listen to an excerpt from an audiobook for an equivalent length of time to the mindfulness practices.
|
Listening to a 10 minute extract from an audiobook
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline (T0) to post-intervention (T2) on the Toronto Mindfulness Scale, State Version (TMS-SV; Lau et al., 2006).
Time Frame: Post-intervention (T2; estimated to be on average 20 minutes after baseline)
|
The TMS-SV measures two facets of state mindfulness, namely curiosity (on a 0 to 24 scale) and decentering (on a 0 to 28 scale), with higher scores indicating greater state mindfulness.
|
Post-intervention (T2; estimated to be on average 20 minutes after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline (T0) to post-allocation (T1) on the Toronto Mindfulness Scale, State Version (TMS-SV; Lau et al., 2006).
Time Frame: Post-allocation (T1; estimated to be on average 5 minutes after baseline)
|
As above
|
Post-allocation (T1; estimated to be on average 5 minutes after baseline)
|
|
Practice Quality-Mindfulness (PQ-M; Del Re et al., 2022) at post-intervention (T2), for the mindfulness practice groups only.
Time Frame: Post-intervention (T2; estimated to be on average 20 minutes after baseline)
|
The PQ-M produces two scores (perseverance and receptivity), each ranging from 0 to 100, that measure two aspects of mindfulness practice quality.
Higher scores indicate greater quality of mindfulness practice.
|
Post-intervention (T2; estimated to be on average 20 minutes after baseline)
|
|
Intention to practice mindfulness in future.
Time Frame: Post-intervention (T2; estimated to be on average 20 minutes after baseline)
|
Participants will be asked a bespoke question to measure how strong their intention is to practice mindfulness in future, on a scale of 0 to 10, with higher scores indicating greater intention to practice.
|
Post-intervention (T2; estimated to be on average 20 minutes after baseline)
|
|
Change from baseline (T0) to post-allocation (T1) on the Positive and Negative Affect Schedule - Postive Affect subscale (PANAS-P; Watson et al., 1988)
Time Frame: Post-allocation (T1; estimated to be on average 5 minutes after baseline)
|
The PANAS-P measures state positive affect on a 1 to 50 scale, with higher scores indicating greater positive affect.
|
Post-allocation (T1; estimated to be on average 5 minutes after baseline)
|
|
Change from baseline (T0) to post-intervention (T2) on the Positive and Negative Affect Schedule - Postive Affect subscale (PANAS-P; Watson et al., 1988)
Time Frame: Post-intervention (T2; estimated to be on average 20 minutes after baseline)
|
As above
|
Post-intervention (T2; estimated to be on average 20 minutes after baseline)
|
|
Change from baseline (T0) to post-allocation (T1) on the Positive and Negative Affect Schedule - Negative Affect subscale (PANAS-N; Watson et al., 1988)
Time Frame: Post-allocation (T1; estimated to be on average 5 minutes after baseline)
|
The PANAS-N measures state negative affect on a 1 to 50 scale, with higher scores indicating greater negative affect.
|
Post-allocation (T1; estimated to be on average 5 minutes after baseline)
|
|
Change from baseline (T0) to post-intervention (T2) on the Positive and Negative Affect Schedule - Negative Affect subscale (PANAS-N; Watson et al., 1988)
Time Frame: Post-allocation (T2; estimated to be on average 20 minutes after baseline)
|
As above
|
Post-allocation (T2; estimated to be on average 20 minutes after baseline)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bobbie Scott, MSc, Canterbury Christ Church University
- Study Chair: Fergal Jones, PhD, Canterbury Christ Church University
- Study Director: Sarah Strohmaier, PhD, Victoria University, Melbourne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DClinPsychol2022BobbieScott/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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