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Completed

NCT Number: NCT06402461

Comparing Random Allocation and Allocation by Preference to Mindfulness Practice

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salomons Institute for Applied Psychology, Canterbury Christ Church University

Royal Tunbridge Wells, Kent, TN1 2YG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness of the breath

Behavioral

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

Mindfulness of sounds

Behavioral

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

Audiobook control

Behavioral

Listening to a 10 minute extract from an audiobook

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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

Sponsors and collaborators

Lead sponsor

Canterbury Christ Church University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 7, 2024
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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