A Large Multi-site Study on Self-administered Mindfulness

NCT06308744 | Completed

• 1 other identifier: 2021-5212-4387
• Study Type: interventional
• Target: 2,239
• Locations: 1 country
• Sites: 1

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… \[recommendation will be provided\].

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Emotion dimensions

  Day 1 - After the listening of the audio track, approximately 25 minutes after the beginning of the survey

Study Arms (2)

Mindfulness conditions

EXPERIMENTAL

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; Behavioral: Mindful Breathing meditation; Behavioral: Loving Kindness meditation; Behavioral: Mindful Walking

Listening of a story

ACTIVE COMPARATOR

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

Interventions

Body-scan meditation BEHAVIORAL

Participants listen to a 15-minute Body-Scan mindfulness meditation recorded by a certified instructor. The audio track is embedded in the Qualtrics survey.

Mindfulness conditions

Mindful Breathing meditation BEHAVIORAL

Participants listen to a 15-minute Mindful Breathing mindfulness meditation recorded by a certified instructor. The audio track is embedded in the Qualtrics survey.

Mindfulness conditions

Loving Kindness meditation BEHAVIORAL

Participants listen to a 15-minute Loving Kindness mindfulness meditation recorded by a certified instructor. The audio track is embedded in the Qualtrics survey.

Mindfulness conditions

Mindful Walking BEHAVIORAL

Participants listen to a 15-minute Mindful Walking mindfulness meditation recorded by a certified instructor. The audio track is embedded in the Qualtrics survey.

Mindfulness conditions

Listening of a story BEHAVIORAL

Participants listen to a 15-minute story. The audio track is embedded in the Qualtrics survey.

Listening of a story

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Swansea University

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

Location

Related Publications (1)

• Sparacio A, IJzerman H, Ropovik I, Giorgini F, Spiessens C, Uchino BN, Landvatter J, Tacana T, Diller SJ, Derrick JL, Segundo J, Pierce JD, Ross RM, Francis Z, LaBoucane A, Ma-Kellams C, Ford MB, Schmidt K, Wong CC, Higgins WC, Stone BM, Stanley SK, Ribeiro G, Fuglestad PT, Jaklin V, Kubler A, Ziebell P, Jewell CL, Kovas Y, Allahghadri M, Fransham C, Baranski MF, Burgess H, Benz ABE, DeSousa M, Nylin CE, Brooks JC, Goldsmith CM, Benson JM, Griffin SM, Dunne S, Davis WE, Watermeyer TJ, Meese WB, Howell JL, Standiford Reyes L, Strickland MG, Dickerson SS, Pescatore S, Skakoon-Sparling S, Wunder ZI, Day MV, Brenton S, Linden AH, Hawk CE, O'Brien LV, Urgyen T, McDonald JS, van der Schans KL, Blocker H, Ng Tseung-Wong C, Jiga-Boy GM. Self-administered mindfulness interventions reduce stress in a large, randomized controlled multi-site study. Nat Hum Behav. 2024 Sep;8(9):1716-1725. doi: 10.1038/s41562-024-01907-7. Epub 2024 Jun 11.

  PMID: 38862815 DERIVED

Study Officials

• Alessandro Sparacio, Ph.D.

  Swansea University & Universite Grenoble Alpes, A*STAR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 13, 2024
• Study Start: March 23, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)