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

Not Applicable

Completed

• Conditions: Healthy Participants

• Registration Number: NCT05115240
• Lead Sponsor: Philipps University Marburg Medical Center

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.

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-10-29
• Study First Posted: 2021-11-10
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in affect	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 Outcome Measures

Name	Time	Method
Change in interoceptive accuracy	Change from pre (baseline) to post scores (30 minutes later)	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 in heart rate variability (HRV)	Change from pre (baseline) to post scores (30 minutes later)	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 in perceived stress	Change from pre (baseline) to post scores (30 minutes later)	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 in state anxiety and depression	Change from pre (baseline) to post scores (30 minutes later)	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).

Trial Locations

Locations (1)

Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg; 🇩🇪 Marburg, Hessen, Germany