Self-administered Mindfulness Interventions Reduce Stress in a Large, Randomized Controlled Multi-site Study
| Registry | NCT06308744 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, basic science |
| Enrollment | 2239 (Actual) |
| Sponsor | Swansea University (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 |
| Conditions | Body Scan Meditation, Loving-Kindness Meditation, Mindful Breathing Meditation, Mindful Walking Meditation, Control Condition |
| Interventions | Body-scan meditation, Mindful Breathing meditation, Loving Kindness meditation, Mindful Walking, Listening of a story (Behavioral) |
| Dates | start 2022-03-23, primary completion 2022-06-30, completion 2022-06-30, first posted 2024-03-13, last updated 2024-03-15 |
| Locations | 1 site in United Kingdom |
Related Papers Related Patents Related Grants Related Experts
All trials for Body Scan Meditation All trials for Loving-Kindness Meditation All trials of Body-scan meditation All trials of Mindful Breathing meditation
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… \[recommendation will be provided\].
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Mindfulness conditions | Experimental | Behavioral: Body-scan meditation; Behavioral: Mindful Breathing meditation; Behavioral: Loving Kindness meditation; Behavioral: Mindful Walking | 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. |
| Listening of a story | Active comparator | Behavioral: Listening of a story | 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. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
* Inclusion Criteria: * 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. * Exclusion Criteria: * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Swansea University | Swansea, Wales, UK | United Kingdom |