A Large Multi-site Study on Self-administered Mindfulness

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].

Study Overview

• Status: Completed
• Conditions: Control Condition; Body Scan Meditation; Loving-Kindness Meditation; Mindful Breathing Meditation; Mindful Walking Meditation
• Intervention / Treatment: Behavioral: Body-scan meditation; Behavioral: Mindful Breathing meditation; Behavioral: Loving Kindness meditation; Behavioral: Mindful Walking; Behavioral: Listening of a story

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 Type: Interventional
• Enrollment (Actual): 2239
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Wales, UK
    • Swansea, Wales, UK, United Kingdom, SA2 8PP
      • Swansea University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness conditions; 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.	Behavioral: Body-scan meditation; Participants listen to a 15-minute Body-Scan mindfulness meditation recorded by a certified instructor. The audio track is embedded in the Qualtrics survey.; Behavioral: Mindful Breathing meditation; Participants listen to a 15-minute Mindful Breathing mindfulness meditation recorded by a certified instructor. The audio track is embedded in the Qualtrics survey.; Behavioral: Loving Kindness meditation; Participants listen to a 15-minute Loving Kindness mindfulness meditation recorded by a certified instructor. The audio track is embedded in the Qualtrics survey.; Behavioral: Mindful Walking; Participants listen to a 15-minute Mindful Walking mindfulness meditation recorded by a certified instructor. The audio track is embedded in the Qualtrics survey.
Active Comparator: 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.	Behavioral: Listening of a story; Participants listen to a 15-minute story. The audio track is embedded in the Qualtrics survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 1 - After the listening of the audio track, approximately 25 minutes after the beginning of the survey

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 - After the listening of the audio track, approximately 25 minutes after the beginning of the survey

Collaborators and Investigators

• Sponsor: Swansea University
• Collaborators: Medical University of South Carolina; Charles University, Czech Republic; Radboud University Medical Center; Wayne State University; University College, London; Ludwig-Maximilians - University of Munich; University of Utah; University of Houston; University of Edinburgh; University of Limerick; Iowa State University; Northumbria University; University of Wuerzburg; Australian National University; University of Milano Bicocca; The University of Queensland; Memorial University of Newfoundland; University of Konstanz; Goldsmiths, University of London; University of California, Merced; Pace University; University of Canberra; University of Northern Iowa; Springfield College; Université Grenoble-Alpes; Idaho State University; University of North Florida; Loyola Marymount University; Behavioural Science Institute; Toronto Metropolitan University; Seeburg University; Ashland University; The College at Brockport; Pennsylvania Western University; Glendale Community College; St. Olaf College; Wittenberg University Ohio; University of Southern Indiana; DigiPen Institute of Technology Redmond; Eastern Oregon University; Spiessens Coaching Solutions Ltd
• Investigators: Principal Investigator: Alessandro Sparacio, Ph.D., Swansea University & Universite Grenoble Alpes, A*STAR

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Mindfulness; stress reduction; self-administered mindfulness; self-help mindfulness; multi-site study
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 2021-5212-4387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan for IPD for the current study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No