nctId: NCT06308744 id: 2021-5212-4387 briefTitle: A Large Multi-site Study on Self-administered Mindfulness overallStatus: COMPLETED date: 2022-03-23 date: 2022-06-30 date: 2022-06-30 date: 2024-03-13 date: 2024-03-15 name: Swansea University class: OTHER name: Université Grenoble-Alpes name: University of Utah name: Seeburg University name: Ludwig-Maximilians - University of Munich name: University of Houston name: Loyola Marymount University name: Ashland University name: The College at Brockport name: Medical University of South Carolina name: Australian National University name: The University of Queensland name: University of North Florida name: University of Wuerzburg name: Iowa State University name: Goldsmiths, University of London name: Pennsylvania Western University name: University of Konstanz name: Springfield College name: Glendale Community College name: St. Olaf College name: University of Limerick name: Northumbria University name: Wittenberg University Ohio name: University of Edinburgh name: University of California, Merced name: University of Southern Indiana name: Pace University name: Toronto Metropolitan University name: Wayne State University name: Memorial University of Newfoundland name: University College, London name: DigiPen Institute of Technology Redmond name: University of Canberra name: University of Northern Iowa name: Idaho State University name: Behavioural Science Institute name: Radboud University Medical Center name: Eastern Oregon University name: Charles University, Czech Republic name: University of Milano Bicocca name: Spiessens Coaching Solutions Ltd 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... \[recommendation will be provided\]. conditions: Body Scan Meditation conditions: Loving-Kindness Meditation conditions: Mindful Breathing Meditation conditions: Mindful Walking Meditation conditions: Control Condition studyType: INTERVENTIONAL phases: NA 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 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 count: 2239 type: ACTUAL name: Body-scan meditation name: Mindful Breathing meditation name: Loving Kindness meditation name: Mindful Walking name: Listening of a story measure: Stress measure: Emotion dimensions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Swansea University city: Swansea state: Wales, UK zip: SA2 8PP country: United Kingdom lat: 51.62079 lon: -3.94323 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 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