Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Real-Time Assessment of Stress and Stress Response

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: NCT04100213
Recruitment Status : Not yet recruiting
First Posted : September 24, 2019
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Stephan T. Egger, Psychiatric University Hospital, Zurich

Brief Summary:
Stress is a complex natural phenomenon, frequently related to a physiological response, including heart rate, heart rate variability, respiratory rate, skin conductance and temperature. The subjective experience varies greatly; broadly, it may be conceived as a freeze, flight, fight, fright or faint response. Many studies have demonstrated the negative influence of psychological stress on health and well-being. Through the digital phenotyping of physiological and psychological stress reactions, in a controlled laboratory setting (Trier Social Stress Test- TSST) and real-life situations, in a population of healthy participants and patients with a major psychiatric disorder, we expect to find reliable and valid digital biomarkers. The results of this study will, therefore, not only contribute to a better understanding of stress and stress response but also have the potential to improve diagnostic and treatment approaches.

Condition or disease Intervention/treatment Phase
Psychiatric Disorder Stress Reaction Stress, Psychological Stress, Physiological Behavioral: Trier Social Stress Test Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Real-Time Assessment of Stress and Stress Response
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: TSST Behavioral: Trier Social Stress Test
The TSST-G is a psychological paradigm which combines high levels of social-evaluative threat and uncontrollability in a group setting. The TSST-G will proceed in groups of three to five participants (from the same diagnostic group). The TSST-G consists of three phases: a briefing; the psychological test itself, followed by a debriefing phase. Each phase will last 40, 20 and 60 minutes, respectively. The briefing and debriefing of the TSST-G will be conducted by experienced psychotherapists. The TSST-G itself will be conducted by personal unknown to the participants.
Other Name: TSST




Primary Outcome Measures :
  1. Cortisol [ Time Frame: Change from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the intervention ]
    Saliva Cortisol Concentration

  2. Subjective Stress [ Time Frame: Change from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the intervention ]
    Stress Questionnaire


Secondary Outcome Measures :
  1. Psychopathological Assessement [ Time Frame: 1 day ]
    Symptom Questionnaire

  2. Psychiatric Diagnosis [ Time Frame: 1 day ]
    Structured psychiatric Interview



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants are competent to give informed consent.
  • Participants are right handed
  • German language proficiency as a native speaker or level B1
  • Diagnosis of a cluster C personality disorder according to ICD-10; or
  • Diagnosis of depressive disorder according to ICD-10; or
  • Diagnosis of schizophrenia or schizoaffective disorder according to ICD-10; or
  • Without a current psychiatric disorder.

Exclusion Criteria:

  • Low Intelligence as confirmed by failure to complete regular compulsory education.
  • Pregnancy or over two weeks delay in the menstrual cycle.
  • Previous participation in a psychological trial involving psychosocial stress assessment.
  • Current neurological disorder.
  • Current cardiovascular disorder.
  • Current respiratory disorder.
  • Current substance use or withdrawal.
  • Any change in medication in the previous week.

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): NCT04100213


Contacts
Layout table for location contacts
Contact: Stephan T. Egger, MD +41523049340 stephan.egger@puk.zh.ch

Locations
Layout table for location information
Switzerland
Psychiatrische Universitätsklinik Zürich
Zürich, Switzerland, 8032
Contact: Stephan T Egger, MD    +4152304940    stephan.egger@puk.zh.ch   
Contact: Godehard Weniger, MD    +41523049341    godehard.weniger@puk.zh.ch   
Sponsors and Collaborators
Psychiatric University Hospital, Zurich
Layout table for additonal information
Responsible Party: Stephan T. Egger, Senior Psychiatrists, Psychiatric University Hospital, Zurich
ClinicalTrials.gov Identifier: NCT04100213    
Other Study ID Numbers: mHealth TSST-G
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephan T. Egger, Psychiatric University Hospital, Zurich:
Stress, Stress Reaction, Trier Social Stress Test, Digital Phenotyping
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Stress
Mental Disorders
Problem Behavior
Stress, Psychological
Behavioral Symptoms
Fractures, Bone
Wounds and Injuries