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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05115240
• Other study ID #: Mindfulness and interoception
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2021
• Source: Philipps University Marburg Medical Center
• Contact: Stefan Salzmann, PhD
• Phone: +4964212823350
• Email: stefan.salzmann[@]uni-marburg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Behavioral:
• 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.

Other:
• Audio-book
Participants listen to an audio book for the same amount of time as the body scan groups

Locations

Country	Name	City	State
Germany	Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg	Marburg	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in perceived stress	Participants are asked to rate how stressed they feel at the moment at two time points (baseline and after body scan or active control intervention) on a questionnaire (VAS: item ranges from 0 (not stressed at all) - 100 (very stressed). Change scores are calculated (post- minus pre-scores). More negative change scores are better since it indicates a stronger stress reduction (maximum reduction: -100). Higher positive change scores are worse since this indicates an increase in perceived stress (maximum increase: +100). Range of change scores: -100 - +100).	Change from pre (baseline) to post scores (30 minutes later)
Secondary	Change in heart rate variability (HRV)	Heart rate variability (HRV) describes the variations between two successive heart beats and is considered a measure for cardiac adaptation to internal and external stimuli. HRV is considered an important transdiagnostic biomarker of health. HRV is frequently quantified using time- domain measures such as the standard deviation of NN intervals (SDNN) and the root mean square of successive differences between normal heartbeats (RMSSD). For HRV levels higher scores are better	Change from pre (baseline) to post scores (30 minutes later)
Secondary	Change in interoceptive accuracy	The heartbeat perception task (Schandry, 1981) encompasses several trials in which participants are instructed to silently count their heartbeats and report the number they counted after each trial. Reported and actual number of heart beats (as assessed by ECG) will be used to calculate a heartbeat detection index (error score).	Change from pre (baseline) to post scores (30 minutes later)
Secondary	Change in state anxiety and depression	The State-Trait-Anxiety-Depression-Inventory (STADI) (Laux, L. Hock, M., Bergner-Köther, R., Hodapp, V. & Renner, K., 2013) measures participants' state anxiety (10 items) and state depression (10 items) severity. Each item can be answered on a 4-point-scale from 1 (not at all) - 4 (very much). Sum scores are calculated and range from 10-40 for each scale (depression and anxiety). Lower scores indicate lower severity (i.e., less negative mood).	Change from pre (baseline) to post scores (30 minutes later)