Effects of Micro-Interventions on Stress Reactivity

The Effects of Brief, Psychological Interventions (Micro-Interventions) on the Individual Stress Reactivity

This study aims to investigate the effects of short, psychological interventions on bio-psychological stress responses after an acute stressor. The efficacy of two different approaches (expectation-bases vs. acceptance-based) will be compared to a control-group.

Study Overview

• Status: Completed
• Conditions: Psychological Stress; Physiological Stress
• Intervention / Treatment: Behavioral: Expectation; Behavioral: Acceptance

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Marburg, Germany, 35032
    • Philipps University Marburg Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• fluent in German language

Exclusion Criteria:

• chronic disease
• mental disease
• the evening before the day of the experiment until end of the experiment (the next day):
• caffeine, alcohol, intensive physical exercise, chewing gum
• acute hay fever
• current intake of psychotropic medication
• current intake of orale contraceptives
• visual impairments
• heart conditions (self and close relatives)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Expectation; Participants are asked to think of three strength which have helped them in prior stressful events. They then have to think of ways how these strength may help them in future stressful situations, i.e. a test in this experiment.	Behavioral: Expectation; writing task
Experimental: Acceptance; Participants listen to an audio-instruction on cognitive defusion. They shall observe the thoughts and feelings of stress and, with the help of the instruction, distance themselves from it.	Behavioral: Acceptance; listening
No Intervention: Control; Participants wait for the stress-test to start.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Subjective Stress Ratings	VAS (visual analogue scale)	at baseline, before the intervention, after the intervention; during the stressor, after the stressor; in total 45 minutes
Change in Cortisol Levels	saliva sample	at baseline (min. -37), after the intervention (min. -19), after the stressor (min. 0), recovery 1 (min. +15), recovery 2 (min. +30); in total 67 minutes
Changes in Heart-Rate-Variability (HRV)	electrocardiogram	during baseline (duration 10 minutes), during the stressor (duration 20 minutes), during recovery (duration 10 minutes); in total 40 minutes
Changes in Affect	VAS (visual analogue scale)	at baseline, after the stressor; in total 45 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Efficacy	questionnaire (self-efficacy scale; Schwarzer & Jerusalem, 1999)	at baseline, after the recovery-phase; in total 55 minutes
Positivity	questionnaire (positivity scale; Caprara et al., 2012, König, 2012)	at baseline, after the recovery-phase; in total 55 minutes

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Investigators: Principal Investigator: Frank Euteneuer, Prof. Dr., Philipps University Marburg Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Actual): October 19, 2020
• Study Completion (Actual): October 19, 2020

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: July 1, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 2019-54k

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No