Skip to main content
Clinical Trials/NCT05115240
NCT05115240
Completed
Not Applicable

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

Philipps University Marburg Medical Center1 site in 1 country66 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Participants
Sponsor
Philipps University Marburg Medical Center
Enrollment
66
Locations
1
Primary Endpoint
Change in affect
Status
Completed
Last Updated
last year

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
December 31, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in affect

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

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.

Secondary Outcomes

  • Change in interoceptive accuracy(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 perceived stress(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 Sites (1)

Loading locations...

Similar Trials