- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04760795
Stress, Personality, Attachment and Coping During the Covid Crisis. (STERACOVID)
July 27, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne
Because of containment due to Covid-19, the French High Authority for Health (HAS) recommended reinforced monitoring of patients taken in care in the psychiatric ward, with special attention for people over the age of 65.
To meet this recommendation, the geriatrics department of the hospital of Charity of Saint-Etienne hospital and the Vinatier hospital in Lyon organized follow-up of these patients by telephone throughout the containment period, thus allowing continuity of care.
This pandemic situation and these measures are unprecedented; it is difficult to anticipate the psychological impact on patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Other: PTSD Check List (PCL) scale
- Other: Brief COPE scale
- Other: GAD-7 (Generalized Anxiety Disorder) scale (during containment)
- Other: Analog scale
- Other: GAD-7 (Generalized Anxiety Disorder) scale (post containment)
- Other: Big Five Inventory (BFI) scale
- Other: Relationship Scales Questionnaire (RSQ)
Detailed Description
The main objective of this study is to evaluate if the type of coping strategies usually employed has an effect on the outbreak of a post-traumatic stress after containment.
In addition, a second part of the study will propose to assess the factors influencing the experience of containment such as personality, attachment style or coping strategies.
Study Type
Observational
Enrollment (Actual)
117
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bron, France
- CH Le Vinatier
-
Saint-Étienne, France
- CHU Saint-Etienne
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients aged of 65 years old et taken in care in the psychiatric ward will be included.
Description
Inclusion Criteria:
- Patients followed by teleconsultation during containment due to COVID 19
- Patient affiliated or entitled to a social security scheme
- Patient who received informed information about the study and who co-signed, with the investigator, a consent to participate in the study (for the part excluding routine care).
Exclusion Criteria:
- Major neurocognitive disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
coping strategy based on problem
59 geriatric patients will be included on the group: coping strategy based on problem
|
PTSD Check List (PCL) scale will be realized to evaluated post-traumatic stress disorder.
Brief COPE scale dispositional version will be realized to evaluated usual coping strategies.
It was assessed during the teleconsultations and post containment.
GAD 7 (Generalized Anxiety Disorder) scale will be realized to evaluated anxiety during containment.
It was assessed during the teleconsultations.
Analog scale will be realized to evaluated anxiety during containment.
It was assessed during the teleconsultations.
GAD-7 (Generalized Anxiety Disorder) scale will be realized to evaluated anxiety during post containment.
Big Five Inventory (BFI) will be realized to evaluated personality.
Relationship Scales Questionnaire (RSQ) will be realized to evaluated attachment style.
|
|
coping strategy based on emotion
59 geriatric patients will be included on the group: coping strategy based on emotion
|
PTSD Check List (PCL) scale will be realized to evaluated post-traumatic stress disorder.
Brief COPE scale dispositional version will be realized to evaluated usual coping strategies.
It was assessed during the teleconsultations and post containment.
GAD 7 (Generalized Anxiety Disorder) scale will be realized to evaluated anxiety during containment.
It was assessed during the teleconsultations.
Analog scale will be realized to evaluated anxiety during containment.
It was assessed during the teleconsultations.
GAD-7 (Generalized Anxiety Disorder) scale will be realized to evaluated anxiety during post containment.
Big Five Inventory (BFI) will be realized to evaluated personality.
Relationship Scales Questionnaire (RSQ) will be realized to evaluated attachment style.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analysis post traumatic stress disorder measured by PTSD Check List (PCL) results
Time Frame: Year: 1
|
The PTSD Check List (PCL) is a self-questionnaire to assess the post traumatic stress disorder and contains 17 items with minimum score 17 (no post traumatic stress disorder) and maximum score at 85 (post traumatic stress disorder important).
|
Year: 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analysis usual coping strategies measured by brief COPE (dispositional version) results
Time Frame: Year: 1
|
Brief COPE (dispositional version) is a questionnaire to assess the usual coping strategies and contains 28 items with minimum score 28 (not at all) and maximum score at 112 (a lot).
|
Year: 1
|
|
Analysis of situation of patients
Time Frame: Year: 1
|
It is composite of analysis of socio-demographic data, conditions of confinement, diagnostic elements.
It was collected in the medical record.
|
Year: 1
|
|
Analysis usual coping strategies during containment measured by brief COPE (dispositional version) results
Time Frame: Year: 1
|
Brief COPE (dispositional version) is a questionnaire to assess the usual coping strategies during containment and contains 28 items with minimum score 28 (not at all) and maximum score at 112 (a lot).
|
Year: 1
|
|
Analysis anxiety during containment measured by GAD-7 (Generalized Anxiety Disorder) results
Time Frame: Year: 1
|
GAD-7 (Generalized Anxiety Disorder) is a questionnaire to assess the anxiety during containment and contains 7 items with minimum score 0 (not anxiety) and maximum score at 21 (anxiety).
|
Year: 1
|
|
Analysis anxiety related to the containment context measured by analogue scale
Time Frame: Year: 1
|
Analogue scale contains minimum score 0 (absence of stress) and maximum score at 10 (stress maximal).
|
Year: 1
|
|
Analysis anxiety post containment measured by GAD-7 (Generalized Anxiety Disorder) results
Time Frame: Year: 1
|
GAD-7 (Generalized Anxiety Disorder) is a questionnaire to assess the anxiety post containment and contains 7 items with minimum score 0 (not anxiety) and maximum score at 21 (anxiety).
|
Year: 1
|
|
Analysis of personalities by Big Five Inventory (BFI) scale
Time Frame: Year: 1
|
Big Five Inventory (BFI) scale to assess the personalities and contains 45 items with 5 dimensions: openness, awareness, extroversion, agreeableness and neurosis.
|
Year: 1
|
|
Analysis attachment measured by Relationship Scales Questionnaire (RSQ) scale results
Time Frame: Year: 1
|
Relationship Scales Questionnaire (RSQ) scale is a questionnaire to assess attachment style and contains 30 items to identify 2 latent dimensions: the "model of oneself" and the "model of the others".
|
Year: 1
|
|
presence of traumatic life events
Time Frame: Year: 1
|
Analysis of presence of traumatic life events
|
Year: 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Isabelle Rouch, MD, CHU Saint-Etienne
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2020
Primary Completion (Actual)
October 19, 2022
Study Completion (Actual)
October 19, 2022
Study Registration Dates
First Submitted
February 17, 2021
First Submitted That Met QC Criteria
February 17, 2021
First Posted (Actual)
February 18, 2021
Study Record Updates
Last Update Posted (Actual)
July 28, 2023
Last Update Submitted That Met QC Criteria
July 27, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRBN922020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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