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Trial record 12 of 545 for:    Recruiting, Not yet recruiting Studies | Psychiatric Problem

Effects of Micro-Interventions on Stress Reactivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04171154
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Philipps University Marburg Medical Center

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.

Condition or disease Intervention/treatment Phase
Psychological Stress Physiological Stress Behavioral: Expectation Behavioral: Acceptance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Effects of Brief, Psychological Interventions (Micro-Interventions) on the Individual Stress Reactivity
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: Expectation
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
writing task

Experimental: Acceptance
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
listening

No Intervention: Control
Participants wait for the stress-test to start.



Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171154


Contacts
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Contact: Irina Unruh, M.Sc. 6421 2824052 ext +49 irina.unruh@uni-marburg.de

Locations
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Germany
Philipps University Marburg Medical Center Recruiting
Marburg, Germany, 35032
Contact: Irina Unruh, M.Sc.    6421 2824052 ext +49    irina.unruh@uni-marburg.de   
Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
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Principal Investigator: Frank Euteneuer, Prof. Dr. Philipps University Marburg Medical Center

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Responsible Party: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT04171154    
Other Study ID Numbers: 2019-54k
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms