Real-Time Assessment of Stress and Stress Response

Stress, Psychological Clinical Trial

Official title:

Real-Time Assessment of Stress and Stress Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04100213
• Other study ID #: mHealth TSST-G
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Psychiatric University Hospital, Zurich
• Contact: Stephan T. Egger, MD
• Phone: +41523049340
• Email: stephan.egger[@]puk.zh.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Stress
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder
• Stress Reaction
• Stress, Physiological
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Psychiatrische Universitätsklinik Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Psychiatric University Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortisol	Saliva Cortisol Concentration	Change from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the intervention
Primary	Subjective Stress	Stress Questionnaire	Change from 40 and 20 min. before the intervention. 0, 10, 20 30, 40, 60 and 80 min. after the intervention
Secondary	Psychopathological Assessement	Symptom Questionnaire	1 day
Secondary	Psychiatric Diagnosis	Structured psychiatric Interview	1 day