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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
coping strategy based on problem
59 geriatric patients will be included on the group: coping strategy based on problem
Other: PTSD Check List (PCL) scale
PTSD Check List (PCL) scale will be realized to evaluated post-traumatic stress disorder.
Other: Brief COPE scale
Brief COPE scale dispositional version will be realized to evaluated usual coping strategies. It was assessed during the teleconsultations and post containment.
Other: GAD-7 (Generalized Anxiety Disorder) scale (during containment)
GAD 7 (Generalized Anxiety Disorder) scale will be realized to evaluated anxiety during containment. It was assessed during the teleconsultations.
Other: Analog scale
Analog scale will be realized to evaluated anxiety during containment. It was assessed during the teleconsultations.
Other: GAD-7 (Generalized Anxiety Disorder) scale (post containment)
GAD-7 (Generalized Anxiety Disorder) scale will be realized to evaluated anxiety during post containment.
Other: Big Five Inventory (BFI) scale
Big Five Inventory (BFI) will be realized to evaluated personality.
Other: Relationship Scales Questionnaire (RSQ)
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
Other: PTSD Check List (PCL) scale
PTSD Check List (PCL) scale will be realized to evaluated post-traumatic stress disorder.
Other: Brief COPE scale
Brief COPE scale dispositional version will be realized to evaluated usual coping strategies. It was assessed during the teleconsultations and post containment.
Other: GAD-7 (Generalized Anxiety Disorder) scale (during containment)
GAD 7 (Generalized Anxiety Disorder) scale will be realized to evaluated anxiety during containment. It was assessed during the teleconsultations.
Other: Analog scale
Analog scale will be realized to evaluated anxiety during containment. It was assessed during the teleconsultations.
Other: GAD-7 (Generalized Anxiety Disorder) scale (post containment)
GAD-7 (Generalized Anxiety Disorder) scale will be realized to evaluated anxiety during post containment.
Other: Big Five Inventory (BFI) scale
Big Five Inventory (BFI) will be realized to evaluated personality.
Other: Relationship Scales Questionnaire (RSQ)
Relationship Scales Questionnaire (RSQ) will be realized to evaluated attachment style.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 19, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 19, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Aging

Clinical Trials on PTSD Check List (PCL) scale

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings