Stress, Personality, Attachment and Coping During the Covid Crisis.

Aging Clinical Trial

— STERACOVID  

Official title:

Stress, Personality, Attachment and Coping During the Covid Crisis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04760795
• Other study ID #: IRBN922020
• Status: Completed
• Start date: November 15, 2020
• Est. completion date: October 19, 2022

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: October 19, 2022
• Est. primary completion date: October 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

Other:
• PTSD Check List (PCL) scale
PTSD Check List (PCL) scale will be realized to evaluated post-traumatic stress disorder.
• 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.
• 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.
• Analog scale
Analog scale will be realized to evaluated anxiety during containment. It was assessed during the teleconsultations.
• GAD-7 (Generalized Anxiety Disorder) scale (post containment)
GAD-7 (Generalized Anxiety Disorder) scale will be realized to evaluated anxiety during post containment.
• Big Five Inventory (BFI) scale
Big Five Inventory (BFI) will be realized to evaluated personality.
• Relationship Scales Questionnaire (RSQ)
Relationship Scales Questionnaire (RSQ) will be realized to evaluated attachment style.

Locations

Country	Name	City	State
France	CH Le Vinatier	Bron
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis post traumatic stress disorder measured by PTSD Check List (PCL) results	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	Analysis usual coping strategies measured by brief COPE (dispositional version) results	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
Secondary	Analysis of situation of patients	It is composite of analysis of socio-demographic data, conditions of confinement, diagnostic elements. It was collected in the medical record.	Year: 1
Secondary	Analysis usual coping strategies during containment measured by brief COPE (dispositional version) results	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
Secondary	Analysis anxiety during containment measured by GAD-7 (Generalized Anxiety Disorder) results	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
Secondary	Analysis anxiety related to the containment context measured by analogue scale	Analogue scale contains minimum score 0 (absence of stress) and maximum score at 10 (stress maximal).	Year: 1
Secondary	Analysis anxiety post containment measured by GAD-7 (Generalized Anxiety Disorder) results	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
Secondary	Analysis of personalities by Big Five Inventory (BFI) scale	Big Five Inventory (BFI) scale to assess the personalities and contains 45 items with 5 dimensions: openness, awareness, extroversion, agreeableness and neurosis.	Year: 1
Secondary	Analysis attachment measured by Relationship Scales Questionnaire (RSQ) scale results	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
Secondary	presence of traumatic life events	Analysis of presence of traumatic life events	Year: 1