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Effects of Micro-Interventions on Stress Reactivity

Primary Purpose

Psychological Stress, Physiological Stress

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Expectation
Acceptance
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psychological Stress

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Philipps University Marburg Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Expectation

Acceptance

Control

Arm Description

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.

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.

Participants wait for the stress-test to start.

Outcomes

Primary Outcome Measures

Change in Subjective Stress Ratings
VAS (visual analogue scale)
Change in Cortisol Levels
saliva sample
Changes in Heart-Rate-Variability (HRV)
electrocardiogram
Changes in Affect
VAS (visual analogue scale)

Secondary Outcome Measures

Self-Efficacy
questionnaire (self-efficacy scale; Schwarzer & Jerusalem, 1999)
Positivity
questionnaire (positivity scale; Caprara et al., 2012, König, 2012)

Full Information

First Posted
November 8, 2019
Last Updated
July 1, 2021
Sponsor
Philipps University Marburg Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04171154
Brief Title
Effects of Micro-Interventions on Stress Reactivity
Official Title
The Effects of Brief, Psychological Interventions (Micro-Interventions) on the Individual Stress Reactivity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
October 19, 2020 (Actual)
Study Completion Date
October 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philipps University Marburg Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress, Physiological Stress

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expectation
Arm Type
Experimental
Arm Description
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.
Arm Title
Acceptance
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants wait for the stress-test to start.
Intervention Type
Behavioral
Intervention Name(s)
Expectation
Intervention Description
writing task
Intervention Type
Behavioral
Intervention Name(s)
Acceptance
Intervention Description
listening
Primary Outcome Measure Information:
Title
Change in Subjective Stress Ratings
Description
VAS (visual analogue scale)
Time Frame
at baseline, before the intervention, after the intervention; during the stressor, after the stressor; in total 45 minutes
Title
Change in Cortisol Levels
Description
saliva sample
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
Title
Changes in Heart-Rate-Variability (HRV)
Description
electrocardiogram
Time Frame
during baseline (duration 10 minutes), during the stressor (duration 20 minutes), during recovery (duration 10 minutes); in total 40 minutes
Title
Changes in Affect
Description
VAS (visual analogue scale)
Time Frame
at baseline, after the stressor; in total 45 minutes
Secondary Outcome Measure Information:
Title
Self-Efficacy
Description
questionnaire (self-efficacy scale; Schwarzer & Jerusalem, 1999)
Time Frame
at baseline, after the recovery-phase; in total 55 minutes
Title
Positivity
Description
questionnaire (positivity scale; Caprara et al., 2012, König, 2012)
Time Frame
at baseline, after the recovery-phase; in total 55 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Euteneuer, Prof. Dr.
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philipps University Marburg Medical Center
City
Marburg
ZIP/Postal Code
35032
Country
Germany

12. IPD Sharing Statement

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Effects of Micro-Interventions on Stress Reactivity

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