The Effects of a Brief Mindfulness Intervention on Emotional Responses and the Moderating Role of Interoception

NCT ID: NCT05115240

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study examines the effects of a brief mindfulness intervention (body scan) on emotional responses (e.g., affect, heart rate variability (HRV)) compared to an active control group. Another aim is to assess whether the effects of the mindfulness intervention can be augmented by optimizing positive expectations. The moderating role of interception on the mindfulness intervention's effects will also be examined.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This 3-armed study examines the effects of a brief mindfulness intervention (audio-guided body scan) on emotional responses (e.g., affect, and heart rate variability (HRV)) compared to an active control group (listening to an audio-book). Another aim is to assess whether the effects of the mindfulness intervention can be augmented by optimizing positive expectations. The moderating role of interception (i.e., interoceptive accuracy as assessed by the Schandry task) on the mindfulness intervention's effects will also be examined.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Audio-guided mindfulness-based intervention (body scan)

Group Type EXPERIMENTAL

Body Scan

Intervention Type BEHAVIORAL

The body scan intervention aims to raise one's awareness of one's own body. It is considered a relaxation, meditation or mindfulness intervention. During the body scan participants will walk through his or her body by focusing their mind on specific body parts without analyzing, judging or reacting.

Enhanced Audio-guided mindfulness-based intervention (body scan)

Participants undergo the same audio-guided body scan intervention. However, in this arm the instruction focuses on the positive effects of mindfulness-based interventions and body scan aiming to optimize participants' interventions outcome expectations of the intervention. The idea of this arm is to assess whether the effects of the mindfulness-based intervention can be augmented by boosting participants positive expectations prior to the intervention.

Group Type EXPERIMENTAL

Body Scan

Intervention Type BEHAVIORAL

The body scan intervention aims to raise one's awareness of one's own body. It is considered a relaxation, meditation or mindfulness intervention. During the body scan participants will walk through his or her body by focusing their mind on specific body parts without analyzing, judging or reacting.

Audio-Book

Participants in this group listen to an audio-book for the same duration as the participants in the two experimental groups.

Group Type ACTIVE_COMPARATOR

Audio-book

Intervention Type OTHER

Participants listen to an audio book for the same amount of time as the body scan groups

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Body Scan

The body scan intervention aims to raise one's awareness of one's own body. It is considered a relaxation, meditation or mindfulness intervention. During the body scan participants will walk through his or her body by focusing their mind on specific body parts without analyzing, judging or reacting.

Intervention Type BEHAVIORAL

Audio-book

Participants listen to an audio book for the same amount of time as the body scan groups

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* fluent in the German language
* ability to give informed consent

Exclusion Criteria

* cardiovascular disease (previous myocardial infarction, hypertension)
* neurological disorders (epilepsy, stroke, multiple sclerosis)
* continuous medication intake (exceptions: contraceptives, nutritional supplements, L-thyroxine for hypothyroidism are allowed)
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Philipps University Marburg

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg

Marburg, Hesse, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Mindfulness and interoception

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MIndfulness for Students
NCT03669016 UNKNOWN NA