protocolSection identificationModule nctId: NCT06308744, orgStudyIdInfo id: 2021-5212-4387, briefTitle: A Large Multi-site Study on Self-administered Mindfulness, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-23, primaryCompletionDateStruct date: 2022-06-30, completionDateStruct date: 2022-06-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Swansea University, class: OTHER, collaborators name: Université Grenoble-Alpes, collaborators name: University of Utah, collaborators name: Seeburg University, collaborators name: Ludwig-Maximilians - University of Munich, collaborators name: University of Houston, collaborators name: Loyola Marymount University, collaborators name: Ashland University, collaborators name: The College at Brockport, collaborators name: Medical University of South Carolina, collaborators name: Australian National University, collaborators name: The University of Queensland, collaborators name: University of North Florida, collaborators name: University of Wuerzburg, collaborators name: Iowa State University, collaborators name: Goldsmiths, University of London, collaborators name: Pennsylvania Western University, collaborators name: University of Konstanz, collaborators name: Springfield College, collaborators name: Glendale Community College, collaborators name: St. Olaf College, collaborators name: University of Limerick, collaborators name: Northumbria University, collaborators name: Wittenberg University Ohio, collaborators name: University of Edinburgh, collaborators name: University of California, Merced, collaborators name: University of Southern Indiana, collaborators name: Pace University, collaborators name: Toronto Metropolitan University, collaborators name: Wayne State University, collaborators name: Memorial University of Newfoundland, collaborators name: University College, London, collaborators name: DigiPen Institute of Technology Redmond, collaborators name: University of Canberra, collaborators name: University of Northern Iowa, collaborators name: Idaho State University, collaborators name: Behavioural Science Institute, collaborators name: Radboud University Medical Center, collaborators name: Eastern Oregon University, collaborators name: Charles University, Czech Republic, collaborators name: University of Milano Bicocca, collaborators name: Spiessens Coaching Solutions Ltd, descriptionModule briefSummary: 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... \[recommendation will be provided\]., conditionsModule conditions: Body Scan Meditation, conditions: Loving-Kindness Meditation, conditions: Mindful Breathing Meditation, conditions: Mindful Walking Meditation, conditions: Control Condition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Participants were not aware of the experimental condition in which they were randomly allocated. Data collection was performed blind to the experimental conditions, but data analysis was not performed blind. However, given that all analyses were pre-registered, it is unlikely that the lack of blinding in data analysis introduced bias., whoMasked: PARTICIPANT, enrollmentInfo count: 2239, type: ACTUAL, armsInterventionsModule interventions name: Body-scan meditation, interventions name: Mindful Breathing meditation, interventions name: Loving Kindness meditation, interventions name: Mindful Walking, interventions name: Listening of a story, outcomesModule primaryOutcomes measure: Stress, secondaryOutcomes measure: Emotion dimensions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Swansea University, city: Swansea, state: Wales, UK, zip: SA2 8PP, country: United Kingdom, geoPoint lat: 51.62079, lon: -3.94323, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2022-03-22, uploadDate: 2024-03-05T01:50, filename: Prot_SAP_000.pdf, size: 606904, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2021-11-05, uploadDate: 2024-03-05T01:51, filename: ICF_001.pdf, size: 240389, hasResults: False