Comparing Random Allocation and Allocation by Preference to Mindfulness Practice

NCT ID: NCT06402461

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2024-11-30

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness of the breath

Intervention Type: BEHAVIORAL

A 10 minute, audio guided, mindfulness of the breath meditation of the sort used in mindfulness-based cognitive therapy

Mindfulness of sounds

Intervention Type: BEHAVIORAL

A 10 minute, audio guided, mindfulness of sounds meditation of the sort used in mindfulness-based cognitive therapy

Allocation by random

Participants are randomly allocated to one of the two mindfulness practices.

Group Type: EXPERIMENTAL

Mindfulness of the breath

Intervention Type: BEHAVIORAL

A 10 minute, audio guided, mindfulness of the breath meditation of the sort used in mindfulness-based cognitive therapy

Mindfulness of sounds

Intervention Type: BEHAVIORAL

A 10 minute, audio guided, mindfulness of sounds meditation of the sort used in mindfulness-based cognitive therapy

Control

Participants listen to an excerpt from an audiobook for an equivalent length of time to the mindfulness practices.

Group Type: ACTIVE_COMPARATOR

Audiobook control

Intervention Type: BEHAVIORAL

Listening to a 10 minute extract from an audiobook

Interventions

Mindfulness of the breath

A 10 minute, audio guided, mindfulness of the breath meditation of the sort used in mindfulness-based cognitive therapy

Intervention Type: BEHAVIORAL

Mindfulness of sounds

A 10 minute, audio guided, mindfulness of sounds meditation of the sort used in mindfulness-based cognitive therapy

Intervention Type: BEHAVIORAL

Audiobook control

Listening to a 10 minute extract from an audiobook

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canterbury Christ Church University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bobbie Scott, MSc

Role: PRINCIPAL_INVESTIGATOR

Canterbury Christ Church University

Fergal Jones, PhD

Role: STUDY_CHAIR

Canterbury Christ Church University

Sarah Strohmaier, PhD

Role: STUDY_DIRECTOR

Victoria University, Melbourne

Locations

Salomons Institute for Applied Psychology, Canterbury Christ Church University

Royal Tunbridge Wells, Kent, United Kingdom

Countries

United Kingdom

Central Contacts

Fergal Jones, PhD

Role: CONTACT

fergal.jones@canterbury.ac.uk

+44 (0) 1227 927110

Facility Contacts

Fergal Jones, PhD

Role: primary

fergal.jones@canterbury.ac.uk

01227 927110

Bobbie Scott, MSc

Role: backup

Other Identifiers

DClinPsychol2022BobbieScott/1

Identifier Type: -

Identifier Source: org_study_id