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Clinical Trials/NCT04171154
NCT04171154CompletedNot Applicable

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

Philipps University Marburg Medical Center1 site in 1 country90 target enrollmentStarted: August 15, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
90
Locations
1
Primary Endpoint
Change in Subjective Stress Ratings

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

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.

Intervention: Expectation (Behavioral)

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.

Intervention: Acceptance (Behavioral)

Control

No Intervention

Participants wait for the stress-test to start.

Outcomes

Primary Outcomes

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)

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

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

Changes in Affect

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

VAS (visual analogue scale)

Secondary Outcomes

  • Self-Efficacy(at baseline, after the recovery-phase; in total 55 minutes)
  • Positivity(at baseline, after the recovery-phase; in total 55 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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