HealthyNCT06402461
Comparing Random Allocation and Allocation by Preference to Mindfulness Practice
A study testing Mindfulness of the breath and Mindfulness of sounds in people with Healthy, run by Canterbury Christ Church University at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mindfulness of the breath and Mindfulness of sounds
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Oct 2025to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Resident in the UK
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Salomons Institute for Applied Psychology, Canterbury Christ Church University
Royal Tunbridge Wells, Kent, TN1 2YG
About this study
Official title: A Randomized Controlled Study Comparing the Effect of Preferential and Random Allocation to Type of Mindfulness Practice in the General Population.
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.
Read the 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
- Being tested
- Mindfulness of the breath, Mindfulness of sounds, Audiobook control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness of the breathBehavioural
A 10 minute, audio guided, mindfulness of the breath meditation of the sort used in mindfulness-based cognitive therapy
Mindfulness of soundsBehavioural
A 10 minute, audio guided, mindfulness of sounds meditation of the sort used in mindfulness-based cognitive therapy
Audiobook controlBehavioural
Listening to a 10 minute extract from an audiobook
| Study group | Role | What they receive |
|---|---|---|
| Allocation by preference | Experimental | Participants are allocated to the one of the two mindfulness practices that they would prefer to do, based on a short description. Receives: Behavioral: Mindfulness of the breath; Behavioral: Mindfulness of sounds |
| Allocation by random | Experimental | Participants are randomly allocated to one of the two mindfulness practices. Receives: Behavioral: Mindfulness of the breath; Behavioral: Mindfulness of sounds |
| Control | Active comparator | Participants listen to an excerpt from an audiobook for an equivalent length of time to the mindfulness practices. Receives: Behavioral: Audiobook control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-intervention (T2; estimated to be on average 20 minutes after baseline)
Secondary outcomes (7)
Change from baseline (T0) to post-allocation (T1) on the Toronto Mindfulness Scale, State Version (TMS-SV; Lau et al., 2006).
As above
Measured: 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.
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.
Measured: Post-intervention (T2; estimated to be on average 20 minutes after baseline)
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.
Measured: 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)
The PANAS-P measures state positive affect on a 1 to 50 scale, with higher scores indicating greater positive affect.
Measured: 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)
As above
Measured: 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)
The PANAS-N measures state negative affect on a 1 to 50 scale, with higher scores indicating greater negative affect.
Measured: 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)
As above
Measured: Post-allocation (T2; estimated to be on average 20 minutes after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start19 Oct 2025
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 3x2x3: 'group' (preference vs. randomly allocation) by 'practice type' (mindfulness of the breath vs. mindfulness of sounds) by 'time' (baseline vs. post-allocation vs. post-intervention).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bobbie Scott, MSc, Principal investigator, Canterbury Christ Church UniversityFergal Jones, PhD, Study chair, Canterbury Christ Church UniversitySarah Strohmaier, PhD, Study director, Victoria University, Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402461
- Sponsor's protocol ID
- DClinPsychol2022BobbieScott/1
- Status last verified
- Nov 2025
- First submitted
- 29 Apr 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the study findings have been published, anonymised IPD will be made available to other researchers upon request and/or published via a university repository.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Comparing the Effect of Preferential and Random Allocation to Type of Mindfulness Practice in the General Population.
- ClinicalTrials.gov ID
- NCT06402461
- Acronym / sponsor ID
- DClinPsychol2022BobbieScott/1
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Study start
- 19 Oct 2025 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3x2x3: 'group' (preference vs. randomly allocation) by 'practice type' (mindfulness of the breath vs. mindfulness of sounds) by 'time' (baseline vs. post-allocation vs. post-intervention).
| Arm | Type | Receives |
|---|---|---|
| Allocation by preference | Experimental | Behavioral: Mindfulness of the breath, Behavioral: Mindfulness of soundsParticipants are allocated to the one of the two mindfulness practices that they would prefer to do, based on a short description. |
| Allocation by random | Experimental | Behavioral: Mindfulness of the breath, Behavioral: Mindfulness of soundsParticipants are randomly allocated to one of the two mindfulness practices. |
| Control | Active comparator | Behavioral: Audiobook controlParticipants listen to an excerpt from an audiobook for an equivalent length of time to the mindfulness practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Resident in the UK
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness of the breathA 10 minute, audio guided, mindfulness of the breath meditation of the sort used in mindfulness-based cognitive therapy | Behavioural | Allocation by preference, Allocation by random |
| Mindfulness of soundsA 10 minute, audio guided, mindfulness of sounds meditation of the sort used in mindfulness-based cognitive therapy | Behavioural | Allocation by preference, Allocation by random |
| Audiobook controlListening to a 10 minute extract from an audiobook | Behavioural | Control |
Primary outcome
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.
7 secondary outcomes
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)
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)
Intention to practice mindfulness in future.
Time frame: 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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Yes. Once the study findings have been published, anonymised IPD will be made available to other researchers upon request and/or published via a university repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bobbie Scott, MSc principal investigator
Canterbury Christ Church University
Fergal Jones, PhD study chair
Canterbury Christ Church University
Sarah Strohmaier, PhD study director
Victoria University, Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness of the breath and Mindfulness of sounds in people with Healthy, run by Canterbury Christ Church University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.