Comparing Random Allocation and Allocation by Preference to Mindfulness Practice

Healthy Clinical Trial

Official title:

A Randomized Controlled Study Comparing the Effect of Preferential and Random Allocation to Type of Mindfulness Practice in the General Population.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06402461
• Other study ID #: DClinPsychol2022BobbieScott/1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Canterbury Christ Church University
• Contact: Fergal Jones, PhD
• Phone: 01227 927110
• Email: fergal.jones[@]canterbury.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 252
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-Resident in the UK

Exclusion Criteria:

• Currently practicing mindfulness meditation more than once per week.

• Experiencing significant mental health problems.

• Experiencing a high level of self-criticism.

• Believe that practicing mindfulness could cause significant distress.

• Previously practicing mindfulness has caused significant distress.

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Mindfulness of the breath
A 10 minute, audio guided, mindfulness of the breath meditation of the sort used in mindfulness-based cognitive therapy
• Mindfulness of sounds
A 10 minute, audio guided, mindfulness of sounds meditation of the sort used in mindfulness-based cognitive therapy
• Audiobook control
Listening to a 10 minute extract from an audiobook

Locations

Country	Name	City	State
United Kingdom	Salomons Institute for Applied Psychology, Canterbury Christ Church University	Tunbridge Wells	Kent

Sponsors (1)

Lead Sponsor	Collaborator
Canterbury Christ Church University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline (T0) to post-intervention (T2) on the Toronto Mindfulness Scale, State Version (TMS-SV; Lau et al., 2006).	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	Change from baseline (T0) to post-allocation (T1) on the Toronto Mindfulness Scale, State Version (TMS-SV; Lau et al., 2006).	As above	Post-allocation (T1; estimated to be on average 5 minutes after baseline)
Secondary	Practice Quality-Mindfulness (PQ-M; Del Re et al., 2022) at post-intervention (T2), for the mindfulness practice groups only.	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)
Secondary	Intention to practice mindfulness in future.	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)
Secondary	Change from baseline (T0) to post-allocation (T1) on the Positive and Negative Affect Schedule - Postive Affect subscale (PANAS-P; Watson et al., 1988)	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)
Secondary	Change from baseline (T0) to post-intervention (T2) on the Positive and Negative Affect Schedule - Postive Affect subscale (PANAS-P; Watson et al., 1988)	As above	Post-intervention (T2; estimated to be on average 20 minutes after baseline)
Secondary	Change from baseline (T0) to post-allocation (T1) on the Positive and Negative Affect Schedule - Negative Affect subscale (PANAS-N; Watson et al., 1988)	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)
Secondary	Change from baseline (T0) to post-intervention (T2) on the Positive and Negative Affect Schedule - Negative Affect subscale (PANAS-N; Watson et al., 1988)	As above	Post-allocation (T2; estimated to be on average 20 minutes after baseline)