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Completed

NCT Number: NCT04171154

Effects of Micro-Interventions on 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.

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Key information

Conditions

Psychological Stress Behavior Behavioral Symptoms Physiological Stress Stress, Psychological

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philipps University Marburg Medical Center

Marburg, 35032, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Expectation

Behavioral

writing task

Acceptance

Behavioral

listening

Primary outcomes

  1. Change in Subjective Stress Ratings

    Time frame: at baseline, before the intervention, after the intervention; during the stressor, after the stressor; in total 45 minutes

    VAS (visual analogue scale)

  2. Change in Cortisol Levels

    Time frame: 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

    saliva sample

  3. Changes in Heart-Rate-Variability (HRV)

    Time frame: during baseline (duration 10 minutes), during the stressor (duration 20 minutes), during recovery (duration 10 minutes); in total 40 minutes

    electrocardiogram

  4. Changes in Affect

    Time frame: at baseline, after the stressor; in total 45 minutes

    VAS (visual analogue scale)

Secondary outcomes

  1. Self-Efficacy

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

    questionnaire (self-efficacy scale; Schwarzer & Jerusalem, 1999)

  2. Positivity

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

    questionnaire (positivity scale; Caprara et al., 2012, König, 2012)

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2019
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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