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].

A Large Multi-site Study on Self-administered Mindfulness

Body Scan Meditation

Loving-Kindness Meditation

Mindful Breathing Meditation

Mindful Walking Meditation

Control Condition

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.

Body-scan meditation

Mindful Breathing meditation

Loving Kindness meditation

Mindful Walking

Listening of a story

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

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).

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.

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.

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.

A Large Multi-site Study on Self-administered Mindfulness

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?