Effects of Micro-Interventions on Stress Reactivity

NCT04171154 | Completed

• 1 other identifier: 2019-54k
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychological Stress; Physiological Stress

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Self-Efficacy

  at baseline, after the recovery-phase; in total 55 minutes

• Positivity

  at baseline, after the recovery-phase; in total 55 minutes

Study Arms (3)

Expectation

EXPERIMENTAL

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

Acceptance

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants wait for the stress-test to start.

Interventions

Expectation BEHAVIORAL

writing task

Expectation

Acceptance BEHAVIORAL

listening

Acceptance

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• fluent in German language

You may not qualify if:

• 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)

Sponsors & Collaborators

• Philipps University Marburg: lead

Study Sites (1)

Philipps University Marburg Medical Center

Marburg, 35032, Germany

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Frank Euteneuer, Prof. Dr.

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 20, 2019
• Study Start: August 15, 2019
• Primary Completion: October 19, 2020
• Study Completion: October 19, 2020
• Last Updated: July 2, 2021

Record last verified: 2021-07

Locations

DE (1)