Clinical trial NCT06308744: A Large Multi-site Study on Self-administered Mindfulness
Official title: Self-administered Mindfulness Interventions Reduce Stress in a Large, Randomized Controlled Multi-site Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Swansea University
Sponsor class: OTHER
Collaborators: name: University Grenoble Alps
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
First posted: 2024-03-13
Enrollment: 2239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief 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. 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.

Eligibility criteria: * 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.

Primary outcomes:
measure: Stress
timeFrame: Day 1 - After the listening of the audio track, approximately 25 minutes after the beginning of the survey
Secondary outcomes:
measure: Emotion dimensions
timeFrame: Day 1 - After the listening of the audio track, approximately 25 minutes after the beginning of the survey
Other outcomes:
Locations:
city: Swansea
country: United Kingdom
facility: Swansea University
state: Wales, UK
Study officials:
affiliation: Swansea University & Universite Grenoble Alpes, A*STAR
name: Alessandro Sparacio, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: