Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04171154
Other study ID # 2019-54k
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 15, 2019
Est. completion date October 19, 2020

Study information

Verified date July 2021
Source Philipps University Marburg Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date October 19, 2020
Est. primary completion date October 19, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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)

Study Design


Intervention

Behavioral:
Expectation
writing task
Acceptance
listening

Locations

Country Name City State
Germany Philipps University Marburg Medical Center Marburg

Sponsors (1)

Lead Sponsor Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary Changes in Affect VAS (visual analogue scale) at baseline, after the stressor; in total 45 minutes
Secondary Self-Efficacy questionnaire (self-efficacy scale; Schwarzer & Jerusalem, 1999) at baseline, after the recovery-phase; in total 55 minutes
Secondary Positivity questionnaire (positivity scale; Caprara et al., 2012, König, 2012) at baseline, after the recovery-phase; in total 55 minutes
See also
  Status Clinical Trial Phase
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed NCT05703087 - Positive Cueing in Knee Arthroplasty. N/A
Completed NCT02541240 - Effects of an Intervention to Enhance Resilience in Physical Therapy Students N/A
Completed NCT02629016 - Stress Reduction: A Pilot Study With Adolescents N/A
Completed NCT01406028 - Does Emotional Support Decrease In Vitro Fertilization Stress? N/A
Completed NCT00121160 - Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response Phase 1
Completed NCT02621775 - Effectiveness of Two Stress Management Programs in Adaptation Disorder With Anxiety (ADA) N/A
Recruiting NCT04474418 - Psychometric Characterization of Patients With Cardiac Arrhythmias
Completed NCT03310112 - Mindfulness Training in U.S. Army Cohorts N/A
Terminated NCT03893617 - Brief Stresses Experimental Study Phase 1
Active, not recruiting NCT05542498 - Promoting Stress Management and Engagement in Introductory Physics Courses With Mindfulness and Relaxation N/A
Completed NCT02394899 - Improving Parental Psychosocial Functioning and Early Developmental Outcomes in Children With Sickle Cell Disease N/A
Terminated NCT00962273 - The Pandemic Stress Vaccine: A Resource to Enhance the Resilience of Healthcare Workers Facing an Infectious Outbreak N/A
Completed NCT00451126 - Moderating Impact of Various Emotion Personality Factors on Salivary Cortisol Response to a TSST N/A
Completed NCT06051500 - Psychological and Physiological Effects of Different Objects of Breath Meditation N/A
Completed NCT02801045 - Art Therapy in Palliative Care: Study of Identification and Understanding of the Mechanisms of Change in the Patient N/A
Completed NCT03308344 - Mindfulness Training in Military Spouses N/A
Recruiting NCT06029348 - Cerebrovascular Health and Resilience in Midlife N/A
Completed NCT04484649 - Sleeping Healthy/Living Healthy Development N/A
Completed NCT05869006 - The Effect of Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice on Psychological Well-Being and Creativity N/A