A Large Multi-site Study on Self-administered Mindfulness

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06308744

Enrollment

2239

Registered

2024-03-13

Start date

2022-03-23

Completion date

2022-06-30

Last updated

2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BEHAVIORALBody-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.

BEHAVIORALMindful 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.

BEHAVIORALLoving 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.

BEHAVIORALMindful 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.

BEHAVIORALListening of a story

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Masking description

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.

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026