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Real-Time Assessment of Stress and Stress Response

Primary Purpose

Psychiatric Disorder, Stress Reaction, Stress, Psychological

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Trier Social Stress Test
Sponsored by
Psychiatric University Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Psychiatric Disorder focused on measuring Stress, Stress Reaction, Trier Social Stress Test, Digital Phenotyping

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Psychiatrische Universitätsklinik ZürichRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TSST

Arm Description

Outcomes

Primary Outcome Measures

Cortisol
Saliva Cortisol Concentration
Subjective Stress
Stress Questionnaire

Secondary Outcome Measures

Psychopathological Assessement
Symptom Questionnaire
Psychiatric Diagnosis
Structured psychiatric Interview

Full Information

First Posted
September 18, 2019
Last Updated
June 25, 2023
Sponsor
Psychiatric University Hospital, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT04100213
Brief Title
Real-Time Assessment of Stress and Stress Response
Official Title
Real-Time Assessment of Stress and Stress Response
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Psychiatric University Hospital, Zurich

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disorder, Stress Reaction, Stress, Psychological, Stress, Physiological
Keywords
Stress, Stress Reaction, Trier Social Stress Test, Digital Phenotyping

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TSST
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Trier Social Stress Test
Other Intervention Name(s)
TSST
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cortisol
Description
Saliva Cortisol Concentration
Time Frame
Change from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the intervention
Title
Subjective Stress
Description
Stress Questionnaire
Time Frame
Change from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the intervention
Secondary Outcome Measure Information:
Title
Psychopathological Assessement
Description
Symptom Questionnaire
Time Frame
1 day
Title
Psychiatric Diagnosis
Description
Structured psychiatric Interview
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephan T. Egger, MD
Phone
+41523049340
Email
stephan.egger@puk.zh.ch
Facility Information:
Facility Name
Psychiatrische Universitätsklinik Zürich
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan T Egger, MD
Phone
+4152304940
Email
stephan.egger@puk.zh.ch
First Name & Middle Initial & Last Name & Degree
Godehard Weniger, MD
Phone
+41523049341
Email
godehard.weniger@puk.zh.ch

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34713030
Citation
Egger ST, Knorr M, Bobes J, Bernstein A, Seifritz E, Vetter S. Real-Time Assessment of Stress and Stress Response Using Digital Phenotyping: A Study Protocol. Front Digit Health. 2020 Oct 15;2:544418. doi: 10.3389/fdgth.2020.544418. eCollection 2020.
Results Reference
derived

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Real-Time Assessment of Stress and Stress Response

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