A Large Multi-site Study on Self-administered Mindfulness

Control Condition Clinical Trial

Official title:

Self-administered Mindfulness Interventions Reduce Stress in a Large, Randomized Controlled Multi-site Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06308744
• Other study ID #: 2021-5212-4387
• Status: Completed
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2024
• Source: Swansea University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2239
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Control Condition
• Respiratory Aspiration

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Swansea University	Swansea	Wales, UK

Sponsors (42)

Lead Sponsor

Collaborator

Swansea University

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"; ?u = 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 a-amylase).	Day 1 - After the listening of the audio track, approximately 25 minutes after the beginning of the survey
Secondary	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