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Neuroendocrine mechanisms Social isolation and psychobiological stress during the Covid-19 pandemic

Organizational Data

DRKS-ID:
DRKS00021671
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2020-05-06
Last update in DRKS:
2023-08-09
Registration type:
Retrospective

Acronym/abbreviation of the study

SoDi Study

URL of the study

https://www.klinikum.uni-heidelberg.de/zentrum-fuer-psychosoziale-medizin-zpm/institut-fuer-medizinische-psychologie/willkommen/studienteilnahme#c254736

Brief summary in lay language

The current Covid-19 virus pandemic and the rules on contact restriction are causing great uncertainty and anxiety for many people. The virus particularly threatens the elderly and the mentally and physically ill, single people suffer from social isolation and people in precarious work situation, the self-employed and small business owners fear for their financial existence. At the same time, social support is restricted and important social relationships are reduced. At the psychobiological level, social support, as well as stress are mediated by hormones oxytocin and cortisol. These substances can be measured non-invasively via repeated saliva samples in everyday life, while at the same time participants report their current stress and social contacts (= ecological momentary assessment, EMA) via an application on their smartphone. The daily measurement consists of two days with 6 daily samples during the pandemic and two days after the removal of contact restrictions. On request, participants are offered psychotherapeutical counselling services.

Brief summary in scientific language

Research by our own and international working groups shows that social contact, close social relationships, physical touches, but also felt closeness, can buffer stress on a psychological and physical level. The health-protective effect of social inclusion was described in overview papers and meta-analyses as even exceeding health-protective behavior (sports, weight reduction, alcohol reduction). The positive effects of social relationships are currently reduced by the necessary requirements of contact restriction and social distancing for the Covid-19 prevention. At the same time, threat directly by the disease, as well as social and economic consequences, has increased significantly. At the psychobiological level, the effect of social support is mediated through the physical stress systems, including the neuropeptide oxytocin, the steroid hormone cortisol (as an effector hormone of the stress-sensitive hypothalamus-pituitary cortex axis, HHNA) and catecholamines of the sympathetic nervous system (an indirect indicator ia the saliva enzyme alpha amylase). These substances can be measured non-invasively in everyday life via repeated saliva samples, at the same time the study participants report their current stressors and social contacts (= psychobiological ecological momentary assessment, EMA) via an application on their smartphones online in real time. During the current crisis, we would like to assess the effects of a) the subjective threat of the virus on individuals, couples and families and b) the simultaneous restrictions on social contact by collecting saliva samples in participants' daily lives.

Health condition or problem studied

Free text:
Persons in quarantine or social isolation
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Cross-section of the population during the Covid-19 pandemic with heterogenous levels of isolation. The subjects are participate over two days in their everyday life using EMA about their current stress levels and their social contacts, in parallel saliva samples for cortisol and oxytocin analyses are collected. Another 2-day measurement will be carried out after the end of the pandemic.

Endpoints

Primary outcome:
Subjective well-being, psychological and physical symptoms (SCL-K9, CTQ, UCLA Loneliness) perceived stress (PSS-10), anxiety and depressiveness (HADS), social relationships (PFB, SCORE-15, F-SozU, SNI), trust. Once during the current pandemic and one after the pandemic.
Secondary outcome:
Psychobiological characteristics of social Isolation. Cortisol and oxytocin levels over 2 days during the pandemic and over 2 days after the end of the pandemic.

Study Design

Purpose:
Basic research/physiological study
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
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Study type non-interventional:
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Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Heidelberg

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2020-04-03
Planned study completion date:
No Entry
Actual Study Completion Date:
2021-08-30
Target Sample Size:
200
Final Sample Size:
249

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
min. 18 years old, informed consent

Exclusion Criteria

underage

Addresses

Primary Sponsor

Institut für Medizinische Psychologie des Universitätsklinikums Heidelberg
Bergheimer Straße 20
79115 Heidelberg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Institut für Medizinische Psychologie des Universitätsklinikums Heidelberg
Monika Eckstein
Bergheimer Straße 20
79115 Heidelberg
Germany
Telephone:
06221567871
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Institut für Medizinische Psychologie des Universitätsklinikums Heidelberg
Ekaterina Schneider
Bergheimer Str. 20
69115 Heidelberg
Germany
Telephone:
06221567871
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Institut für Medizinische Psychologie des Universitätsklinikums Heidelberg
Monika Eckstein
Bergheimer Straße 20
79115 Heidelberg
Germany
Telephone:
06221567871
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Institut für Medizinische Psychologie am Uniklinikum Heidelberg
69115 Heidelberg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Medizinischen Fakultät Heidelberg
Alte Glockengießerei 11/1
69115 Heidelberg
Germany
Telephone:
+49-6221-338220
Fax:
+49-6221-3382222
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2020-04-01
Ethics committee number:
S-214/2020
Vote of the Ethics Committee:
Approved
Date of the vote:
2020-04-03

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
After final completion of the study and after the publication of all planned results, the data will be available anonymously via HeiData (platform of Heidelberg University).

Study protocol and other study documents

Study protocols:
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Study abstract:
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Other study documents:
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Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry