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

NCT05115240 | Completed

• 1 other identifier: Mindfulness and interoception
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Change in affect

  Participants are asked to rate adjectives regarding their current mood (positive and negative) at two time points (baseline and after body scan or active control intervention) on a questionnaire. Change scores are calculated (post- minus pre-scores). Instrument: Positive and Negative Affect Scale (PANAS) by Watson, Clark, and Tellegen (1988) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Range for sum score of positive/negative affect: 10-50. For positive affect higher scores are better; for negative affect lower scores are better.

  Change from pre (baseline) to post scores (30 minutes later)

Secondary Outcomes (4)

• Change in perceived stress

  Change from pre (baseline) to post scores (30 minutes later)

• Change in heart rate variability (HRV)

  Change from pre (baseline) to post scores (30 minutes later)

• Change in interoceptive accuracy

  Change from pre (baseline) to post scores (30 minutes later)

• Change in state anxiety and depression

  Change from pre (baseline) to post scores (30 minutes later)

Study Arms (3)

Audio-guided mindfulness-based intervention (body scan)

EXPERIMENTAL

Behavioral: Body Scan

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

EXPERIMENTAL

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.

Behavioral: Body Scan

Audio-Book

ACTIVE COMPARATOR

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

Other: Audio-book

Interventions

Body Scan 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-guided mindfulness-based intervention (body scan); Enhanced Audio-guided mindfulness-based intervention (body scan)

Audio-book OTHER

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

Audio-Book

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipps University Marburg: lead

Study Sites (1)

Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg

Marburg, Hesse, 35032, Germany

Location

MeSH Terms

Interventions

Whole Body Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 10, 2021
• Study Start: October 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

DE (1)