Effects of Micro-Interventions on Stress Reactivity

Psychological Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04171154
• Other study ID #: 2019-54k
• Status: Completed
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: October 19, 2020

Study information

• Verified date: July 2021
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 19, 2020
• Est. primary completion date: October 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Physiological Stress
• Psychological Stress
• Stress, Psychological

Intervention

Behavioral:
• Expectation
writing task
• Acceptance
listening

Locations

Country	Name	City	State
Germany	Philipps University Marburg Medical Center	Marburg

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 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
Primary	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
Primary	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
Primary	Changes in Affect	VAS (visual analogue scale)	at baseline, after the stressor; in total 45 minutes
Secondary	Self-Efficacy	questionnaire (self-efficacy scale; Schwarzer & Jerusalem, 1999)	at baseline, after the recovery-phase; in total 55 minutes
Secondary	Positivity	questionnaire (positivity scale; Caprara et al., 2012, König, 2012)	at baseline, after the recovery-phase; in total 55 minutes