Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402461
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-04-29
Brief Title:
Comparing Random Allocation and Allocation by Preference to Mindfulness Practice
Sponsor:
Canterbury Christ Church University
Organization:
Canterbury Christ Church University
Study Overview
Official Title:
A Randomized Controlled Study Comparing the Effect of Preferential and Random Allocation to Type of Mindfulness Practice in the General Population
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized controlled study is to examine whether allocation based on preference to one of two brief mindfulness meditation practices mindfulness of the breath or mindfulness of sounds influences the potentially beneficial effects of these practices and influences participants intention to engage in further mindfulness practice To the end members of the general public will be randomly assigned to one of three groups 1 a group in which they choose which of the two mindfulness practices they do 2 a group in which they are randomly allocated to do one of the mindfulness practices and 3 a control group that listens to an audiobook extract The level of mindfulness of each group will be compared along with some other outcomes
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
H4The 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
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
H4The 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None