Body Scan MeditationNCT06308744
A Large Multi-site Study on Self-administered Mindfulness
A study testing Body-scan meditation, Mindful Breathing meditation and Loving Kindness meditation in people with Body Scan Meditation and Loving-Kindness Meditation, run by Swansea University at 1 site in United Kingdom.
Trial summary
The use of self-administered mindfulness interventions has increased in recent years. The effectiveness of these interventions on regulating stress/emotions, however, is debated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Body Scan Meditation, Loving-Kindness Meditation, Mindful Breathing Meditation
- What is being tested?
- Body-scan meditation, Mindful Breathing meditation and Loving Kindness meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,239 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Mar 2022to 30 Jun 2022
- 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
- Adult participants aged 18 years or older at the time of the study.
- Participants who are English native speakers or who self-assessed their English language proficiency at the C1/C2 levels from the Common European Framework of Reference for Languages.
Who cannot join
- Participants with a current or past history of mental illnesses (assessed via a pre-screening question).
- Participants who have engaged in meditation within six months prior to data collection.
- Participants who do not meet the English language proficiency requirements specified in the 'Inclusion Criteria' section.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-administered Mindfulness Interventions Reduce Stress in a Large, Randomized Controlled Multi-site Study
The use of self-administered mindfulness interventions has increased in recent years. The effectiveness of these interventions on regulating stress/emotions, however, is debated. In the present multi-site study (Nsites = x, Nparticipants = x), the investigators aimed to investigate the effectiveness of four single, brief stand-alone mindfulness exercises in a population unfamiliar with mindfulness meditation. The investigators tested these four interventions in comparison to non-mindful active control conditions using an adaptive Bayesian design. The investigators found [evidence for the efficacy of x exercises/no evidence for the efficacy of x exercises] with an estimated mean effect size of [xx/xx]. This means that… or The investigators recommend that… [recommendation will be provided].
Read the detailed description
Author's note:
The current project was pre-registered on the Open Science Framework (OSF) on March 22nd 2022, which was prior to the start of data collection (https://doi.org/10.17605/OSF.IO/UF4JZ). Data collection started on March 23th 2022 and ended on June 30th 2022. The investigators are retroactively registering the current study upon request of the editor who reviewed their manuscript (to comply with the editorial policies and formatting requirements of the target journal). The following protocol is an abbreviated version of the one the investigators uploaded on the OSF (https://osf.io/us5ae).
The upcoming multi-site project 'Self-administered mindfulness interventions reduce stress in a large, randomized controlled multi-site study' will aim to deliver in-depth insights into how self-administered mindfulness exercises impact stress reduction. It will focus on evaluating the effectiveness of self-administered mindfulness exercises in reducing stress among a large and diverse group of participants. Participants will be randomized to one of the audio-mindfulness exercises or to an active control condition. All exercises and the active control condition instructions will be designed to last 15 minutes. The active control condition will consist of a matched non-mindful listening condition in which mindfulness will not be mentioned. After the end of this intervention, a questionnaire will assess the self-reported stress of individuals with a short-term efficacy span. The study will also investigate the potential role of neuroticism as a moderator, as previous research has negatively associated neuroticism with mindfulness traits (i.e., the ability to be grounded in the present moment; Walsh et al., 2009). Bayesian sequential analysis tools (Schönbrodt et al., 2017) will be used to monitor the progress and to test the efficacy of each self-administered mindfulness exercise (i.e., upon reaching a predefined Bayes Factors). The results of this multi-site project will provide an answer to whether brief, stand-alone mindfulness exercises can demonstrate efficacy in decreasing levels of stress in individuals.
- Conditions
- Body Scan Meditation, Loving-Kindness Meditation, Mindful Breathing Meditation, Mindful Walking Meditation, Control Condition
- Being tested
- Body-scan meditation, Mindful Breathing meditation, Loving Kindness meditation, Mindful Walking, Listening of a story
- Keywords
- Mindfulness, self-administered mindfulness, self-help mindfulness, multi-site study, stress reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body-scan meditationBehavioural
Participants listen to a 15-minute Body-Scan mindfulness meditation recorded by a certified instructor. The audio track is embedded in the Qualtrics survey.
Mindful Breathing meditationBehavioural
Participants listen to a 15-minute Mindful Breathing mindfulness meditation recorded by a certified instructor. The audio track is embedded in the Qualtrics survey.
Loving Kindness meditationBehavioural
Participants listen to a 15-minute Loving Kindness mindfulness meditation recorded by a certified instructor. The audio track is embedded in the Qualtrics survey.
Mindful WalkingBehavioural
Participants listen to a 15-minute Mindful Walking mindfulness meditation recorded by a certified instructor. The audio track is embedded in the Qualtrics survey.
Listening of a storyBehavioural
Participants listen to a 15-minute story. The audio track is embedded in the Qualtrics survey.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness conditions | Experimental | Participants will engage in a 15-minute mindfulness meditation session. Within this framework, four distinct experimental conditions will be introduced, each showcasing a unique mindfulness exercise: Body Scan, Mindful Breathing, Mindful Walking, and Loving-Kindness Meditation. The audio tracks of the mindfulness experimental conditions is embedded in the Qualtrics survey. Receives: Behavioral: Body-scan meditation; Behavioral: Mindful Breathing meditation; Behavioral: Loving Kindness meditation; Behavioral: Mindful Walking |
| Listening of a story | Active comparator | Participants in the active control condition listened to a 15-minute story. The audio track of the control condition is embedded in the Qualtrics survey. Receives: Behavioral: Listening of a story |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
Participants answer the 20-item State-Trait Anxiety Inventory, Form Y-1 (STAI19). Participants indicate how they felt in that exact moment on 20 items (e.g., "I am tense"; "I feel frightened"; ωu = 0.92) on a 4-point scale (1 = Not at all, 2 = Somewhat, 3 = Moderately so, 4 = Very much so). By using the STAI Form Y-1 scale, the investigators aimed to measure the short-term effects of stress on individuals. This scale, after all, has been shown to correlate with biomarkers of stress in previous research (salivary α-amylase).
Measured: Day 1 - After the listening of the audio track, approximately 25 minutes after the beginning of the survey
Secondary outcomes (1)
Emotion dimensions
Participants filled in the Self-Assessment Manikin scale, a 3-item non-verbal pictorial assessment technique that measures emotions on three different dimensions, namely pleasure, arousal, and dominance. The Self-Assessment Manikin scale is the picture-oriented version of the widely used Semantic Differential Scale. This instrument measures the three-dimensional structure of stimuli, objects, and situations with 18 bipolar adjective pairs that can be rated along a 9-point scale. This measure was not the primary dependent variable of the study, but the investigators added it in the study for the exploratory analyses.
Measured: Day 1 - After the listening of the audio track, approximately 25 minutes after the beginning of the survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start23 Mar 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Scan MeditationStudies 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
- Parallel groups
- Model description
- The current multi-site project followed the route of a parallel randomized controlled trial. Each participant was randomly allocated to either an experimental condition corresponding to a 15-minute audio listening of one of four different mindfulness exercises (i.e., mindful walking, mindful breathing, body scan and loving kindness meditation) or to a control condition (i.e., listening to a 15-minute audio story excerpt). Participants who were assigned to the control group randomly listened to an excerpt of one of the three stories that the investigators selected for the present study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps, University of Utah, Seeburg University, Ludwig-Maximilians - University of Munich, University of Houston, Loyola Marymount University, Ashland University, SUNY Brockport, Medical University of South Carolina, Australian National University, The University of Queensland, University of North Florida, University of Wuerzburg, Iowa State University, Goldsmiths, University of London, Pennsylvania Western University, University of Konstanz, Springfield College, Glendale Community College, St. Olaf College, University of Limerick, Northumbria University, Wittenberg University Ohio, University of Edinburgh, University of California, Merced, University of Southern Indiana, Pace University, Toronto Metropolitan University, Wayne State University, Memorial University of Newfoundland, University College, London, DigiPen Institute of Technology Redmond, University of Canberra, University of Northern Iowa, Idaho State University, Behavioural Science Institute, Radboud University Medical Center, Eastern Oregon University, Charles University, Czech Republic, University of Milano Bicocca, Spiessens Coaching Solutions Ltd
- Responsible party
- Sponsor
- Investigators
- Alessandro Sparacio, Ph.D., Principal investigator, Swansea University & Universite Grenoble Alpes, A*STAR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308744
- Sponsor's protocol ID
- 2021-5212-4387
- Status last verified
- Feb 2024
- First submitted
- 27 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan for IPD for the current study.
Publications
Sparacio A, IJzerman H, Ropovik I, Giorgini F, Spiessens C, Uchino BN, Landvatter J, Tacana T, Diller SJ, Derrick JL, Segundo J, Pierce JD, Ross RM, Francis Z, LaBoucane A, Ma-Kellams C, Ford MB, Schmidt K, Wong CC, Higgins WC, Stone BM, Stanley SK, Ribeiro G, Fuglestad PT, Jaklin V, Kubler A, Ziebell P, Jewell CL, Kovas Y, Allahghadri M, Fransham C, Baranski MF, Burgess H, Benz ABE, DeSousa M, Nylin CE, Brooks JC, Goldsmith CM, Benson JM, Griffin SM, Dunne S, Davis WE, Watermeyer TJ, Meese WB, Howell JL, Standiford Reyes L, Strickland MG, Dickerson SS, Pescatore S, Skakoon-Sparling S, Wunder ZI, Day MV, Brenton S, Linden AH, Hawk CE, O'Brien LV, Urgyen T, McDonald JS, van der Schans KL, Blocker H, Ng Tseung-Wong C, Jiga-Boy GM. Self-administered mindfulness interventions reduce stress in a large, randomized controlled multi-site study. Nat Hum Behav. 2024 Sep;8(9):1716-1725. doi: 10.1038/s41562-024-01907-7. Epub 2024 Jun 11.
PubMed 38862815
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-administered Mindfulness Interventions Reduce Stress in a Large, Randomized Controlled Multi-site Study
- ClinicalTrials.gov ID
- NCT06308744
- Acronym / sponsor ID
- 2021-5212-4387
- Conditions
- Body Scan Meditation, Loving-Kindness Meditation, Mindful Breathing Meditation, Mindful Walking Meditation, Control Condition
- Keywords
- Mindfulness, self-administered mindfulness, self-help mindfulness, multi-site study, stress reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,239 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Collaborators
- University Grenoble Alps, University of Utah, Seeburg University, Ludwig-Maximilians - University of Munich, University of Houston, Loyola Marymount University, Ashland University, SUNY Brockport, Medical University of South Carolina, Australian National University, The University of Queensland, University of North Florida, University of Wuerzburg, Iowa State University, Goldsmiths, University of London, Pennsylvania Western University, University of Konstanz, Springfield College, Glendale Community College, St. Olaf College, University of Limerick, Northumbria University, Wittenberg University Ohio, University of Edinburgh, University of California, Merced, University of Southern Indiana, Pace University, Toronto Metropolitan University, Wayne State University, Memorial University of Newfoundland, University College, London, DigiPen Institute of Technology Redmond, University of Canberra, University of Northern Iowa, Idaho State University, Behavioural Science Institute, Radboud University Medical Center, Eastern Oregon University, Charles University, Czech Republic, University of Milano Bicocca, Spiessens Coaching Solutions Ltd
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 13 Mar 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 use of self-administered mindfulness interventions has increased in recent years. The effectiveness of these interventions on regulating stress/emotions, however, is debated. In the present multi-site study (Nsites = x, Nparticipants = x), the investigators aimed to investigate the effectiveness of four single, brief stand-alone mindfulness exercises in a population unfamiliar with mindfulness meditation. The investigators tested these four interventions in comparison to non-mindful active control conditions using an adaptive Bayesian design. The investigators found [evidence for the efficacy of x exercises/no evidence for the efficacy of x exercises] with an estimated mean effect size of [xx/xx]. This means that… or The investigators recommend that… [recommendation will be provided].
Detailed description
Author's note:
The current project was pre-registered on the Open Science Framework (OSF) on March 22nd 2022, which was prior to the start of data collection (https://doi.org/10.17605/OSF.IO/UF4JZ). Data collection started on March 23th 2022 and ended on June 30th 2022. The investigators are retroactively registering the current study upon request of the editor who reviewed their manuscript (to comply with the editorial policies and formatting requirements of the target journal). The following protocol is an abbreviated version of the one the investigators uploaded on the OSF (https://osf.io/us5ae).
The upcoming multi-site project 'Self-administered mindfulness interventions reduce stress in a large, randomized controlled multi-site study' will aim to deliver in-depth insights into how self-administered mindfulness exercises impact stress reduction. It will focus on evaluating the effectiveness of self-administered mindfulness exercises in reducing stress among a large and diverse group of participants. Participants will be randomized to one of the audio-mindfulness exercises or to an active control condition. All exercises and the active control condition instructions will be designed to last 15 minutes. The active control condition will consist of a matched non-mindful listening condition in which mindfulness will not be mentioned. After the end of this intervention, a questionnaire will assess the self-reported stress of individuals with a short-term efficacy span. The study will also investigate the potential role of neuroticism as a moderator, as previous research has negatively associated neuroticism with mindfulness traits (i.e., the ability to be grounded in the present moment; Walsh et al., 2009). Bayesian sequential analysis tools (Schönbrodt et al., 2017) will be used to monitor the progress and to test the efficacy of each self-administered mindfulness exercise (i.e., upon reaching a predefined Bayes Factors). The results of this multi-site project will provide an answer to whether brief, stand-alone mindfulness exercises can demonstrate efficacy in decreasing levels of stress in individuals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The current multi-site project followed the route of a parallel randomized controlled trial. Each participant was randomly allocated to either an experimental condition corresponding to a 15-minute audio listening of one of four different mindfulness exercises (i.e., mindful walking, mindful breathing, body scan and loving kindness meditation) or to a control condition (i.e., listening to a 15-minute audio story excerpt). Participants who were assigned to the control group randomly listened to an excerpt of one of the three stories that the investigators selected for the present study.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness conditions | Experimental | Behavioral: Body-scan meditation, Behavioral: Mindful Breathing meditation, Behavioral: Loving Kindness meditation, Behavioral: Mindful WalkingParticipants will engage in a 15-minute mindfulness meditation session. Within this framework, four distinct experimental conditions will be introduced, each showcasing a unique mindfulness exercise: Body Scan, Mindful Breathing, Mindful Walking, and Loving-Kindness Meditation. The audio tracks of the mindfulness experimental conditions is embedded in the Qualtrics survey. |
| Listening of a story | Active comparator | Behavioral: Listening of a storyParticipants in the active control condition listened to a 15-minute story. The audio track of the control condition is embedded in the Qualtrics survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult participants aged 18 years or older at the time of the study.
- Participants who are English native speakers or who self-assessed their English language proficiency at the C1/C2 levels from the Common European Framework of Reference for Languages.
Key exclusion criteria (3 listed)
- Participants with a current or past history of mental illnesses (assessed via a pre-screening question).
- Participants who have engaged in meditation within six months prior to data collection.
- Participants who do not meet the English language proficiency requirements specified in the 'Inclusion Criteria' section.
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 |
|---|---|---|
| Body-scan meditationParticipants listen to a 15-minute Body-Scan mindfulness meditation recorded by a certified instructor. The audio track is embedded in the Qualtrics survey. | Behavioural | Mindfulness conditions |
| Mindful Breathing meditationParticipants listen to a 15-minute Mindful Breathing mindfulness meditation recorded by a certified instructor. The audio track is embedded in the Qualtrics survey. | Behavioural | Mindfulness conditions |
| Loving Kindness meditationParticipants listen to a 15-minute Loving Kindness mindfulness meditation recorded by a certified instructor. The audio track is embedded in the Qualtrics survey. | Behavioural | Mindfulness conditions |
| Mindful WalkingParticipants listen to a 15-minute Mindful Walking mindfulness meditation recorded by a certified instructor. The audio track is embedded in the Qualtrics survey. | Behavioural | Mindfulness conditions |
| Listening of a storyParticipants listen to a 15-minute story. The audio track is embedded in the Qualtrics survey. | Behavioural | Listening of a story |
Primary outcome
Stress
Time frame: Day 1 - After the listening of the audio track, approximately 25 minutes after the beginning of the survey
Participants answer the 20-item State-Trait Anxiety Inventory, Form Y-1 (STAI19). Participants indicate how they felt in that exact moment on 20 items (e.g., "I am tense"; "I feel frightened"; ωu = 0.92) on a 4-point scale (1 = Not at all, 2 = Somewhat, 3 = Moderately so, 4 = Very much so). By using the STAI Form Y-1 scale, the investigators aimed to measure the short-term effects of stress on individuals. This scale, after all, has been shown to correlate with biomarkers of stress in previous research (salivary α-amylase).
1 secondary outcome
Emotion dimensions
Time frame: Day 1 - After the listening of the audio track, approximately 25 minutes after the beginning of the survey
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 15 Mar 2024.
- Derived from this study: PubMed 38862815Sparacio A, IJzerman H, Ropovik I, Giorgini F, Spiessens C, Uchino BN, Landvatter J, Tacana T, Diller SJ, Derrick JL, Segundo J, Pierce JD, Ross RM, Francis Z, LaBoucane A, Ma-Kellams C, Ford MB, Schmidt K, Wong CC, Higgins WC, Stone BM, Stanley SK, Ribeiro G, Fuglestad PT, Jaklin V, Kubler A, Ziebell P, Jewell CL, Kovas Y, Allahghadri M, Fransham C, Baranski MF, Burgess H, Benz ABE, DeSousa M, Nylin CE, Brooks JC, Goldsmith CM, Benson JM, Griffin SM, Dunne S, Davis WE, Watermeyer TJ, Meese WB, Howell JL, Standiford Reyes L, Strickland MG, Dickerson SS, Pescatore S, Skakoon-Sparling S, Wunder ZI, Day MV, Brenton S, Linden AH, Hawk CE, O'Brien LV, Urgyen T, McDonald JS, van der Schans KL, Blocker H, Ng Tseung-Wong C, Jiga-Boy GM. Self-administered mindfulness interventions reduce stress in a large, randomized controlled multi-site study. Nat Hum Behav. 2024 Sep;8(9):1716-1725. doi: 10.1038/s41562-024-01907-7. Epub 2024 Jun 11.
- Individual participant dataSharing planned: No. There is no plan for IPD for the current study.
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.
Alessandro Sparacio, Ph.D. principal investigator
Swansea University & Universite Grenoble Alpes, A*STAR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body-scan meditation, Mindful Breathing meditation and Loving Kindness meditation in people with Body Scan Meditation and Loving-Kindness Meditation, run by Swansea 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 2 inclusion and 3 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 15 Mar 2024. 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?
Stress (time frame: Day 1 - After the listening of the audio track, approximately 25 minutes after the beginning of the survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06308744, which also lists 1 linked publication.
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 15 Mar 2024.