Psychiatric DisorderSTERACOVIDNCT04760795
Stress, Personality, Attachment and Coping During the Covid Crisis.
An observational study of Psychiatric Disorder and Aging, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Psychiatric Disorder, Aging
- What is being tested?
- PTSD Check List (PCL) scale, Brief COPE scale and GAD-7 (Generalized Anxiety Disorder) scale (during containment)
- How many people
- 117 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Nov 2020to 19 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged of 65 years old et taken in care in the psychiatric ward will be included.
Who may be able to join
- 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).
Who cannot join
- Major neurocognitive disorder
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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.
- Conditions
- Psychiatric Disorder, Aging
- Being tested
- PTSD Check List (PCL) scale, Brief COPE scale, GAD-7 (Generalized Anxiety Disorder) scale (during containment), Analog scale, GAD-7 (Generalized Anxiety Disorder) scale (post containment)
- Keywords
- COVID-19, teleconsultation, Stress, containment, post-traumatic stress
- Medical subject headings
- Mental Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTSD Check List (PCL) scaleOther
PTSD Check List (PCL) scale will be realized to evaluated post-traumatic stress disorder.
Brief COPE scaleOther
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)Other
GAD 7 (Generalized Anxiety Disorder) scale will be realized to evaluated anxiety during containment. It was assessed during the teleconsultations.
Analog scaleOther
Analog scale will be realized to evaluated anxiety during containment. It was assessed during the teleconsultations.
GAD-7 (Generalized Anxiety Disorder) scale (post containment)Other
GAD-7 (Generalized Anxiety Disorder) scale will be realized to evaluated anxiety during post containment.
Big Five Inventory (BFI) scaleOther
Big Five Inventory (BFI) will be realized to evaluated personality.
Relationship Scales Questionnaire (RSQ)Other
Relationship Scales Questionnaire (RSQ) will be realized to evaluated attachment style.
| Study group | Role | What they receive |
|---|---|---|
| coping strategy based on problem | 59 geriatric patients will be included on the group: coping strategy based on problem Receives: 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) | |
| coping strategy based on emotion | 59 geriatric patients will be included on the group: coping strategy based on emotion Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Year: 1
Secondary outcomes (9)
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).
Measured: Year: 1
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.
Measured: Year: 1
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).
Measured: Year: 1
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).
Measured: Year: 1
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).
Measured: Year: 1
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).
Measured: Year: 1
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.
Measured: Year: 1
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".
Measured: Year: 1
presence of traumatic life events
Analysis of presence of traumatic life events
Measured: Year: 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start15 Nov 2020
- Primary completion19 Oct 2022
- Study completion19 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Rouch, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760795
- Sponsor's protocol ID
- IRBN922020
- Acronym
- STERACOVID
- Status last verified
- Jul 2023
- First submitted
- 17 Feb 2021
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pongan E, Rouch I, Herrmann M, Perrot C, Lebrun-Givois C, Spirli L, Briollet C, Martin HS, Laurent B, Bachelet R, El Haouari H, Buisson A, Edjolo A, Dorey JM. Anxiety symptoms during COVID-19 in older adults with psychiatric disorders. Front Psychiatry. 2023 Jan 16;13:1082807. doi: 10.3389/fpsyt.2022.1082807. eCollection 2022.
PubMed 36741567Edjolo A, Dorey JM, Herrmann M, Perrot C, Lebrun-Givois C, Buisson A, El Haouari H, Laurent B, Pongan E, Rouch I. Stress, Personality, Attachment, and Coping Strategies During the COVID-19 Pandemic: The STERACOVID Prospective Cohort Study Protocol. Front Psychiatry. 2022 Jun 27;13:918428. doi: 10.3389/fpsyt.2022.918428. eCollection 2022.
PubMed 35832598
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress, Personality, Attachment and Coping During the Covid Crisis.
- ClinicalTrials.gov ID
- NCT04760795
- Acronym / sponsor ID
- STERACOVID / IRBN922020
- Conditions
- Psychiatric Disorder, Aging
- Keywords
- COVID-19, teleconsultation, Stress, containment, post-traumatic stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coping strategy based on problem | – | 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)59 geriatric patients will be included on the group: coping strategy based on problem |
| coping strategy based on emotion | – | 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)59 geriatric patients will be included on the group: coping strategy based on emotion |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged of 65 years old et taken in care in the psychiatric ward will be included.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Major neurocognitive disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTSD Check List (PCL) scalePTSD Check List (PCL) scale will be realized to evaluated post-traumatic stress disorder. | Other | coping strategy based on emotion, coping strategy based on problem |
| Brief COPE scaleBrief COPE scale dispositional version will be realized to evaluated usual coping strategies. It was assessed during the teleconsultations and post containment. | Other | coping strategy based on emotion, coping strategy based on problem |
| 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 | coping strategy based on emotion, coping strategy based on problem |
| Analog scaleAnalog scale will be realized to evaluated anxiety during containment. It was assessed during the teleconsultations. | Other | coping strategy based on emotion, coping strategy based on problem |
| GAD-7 (Generalized Anxiety Disorder) scale (post containment)GAD-7 (Generalized Anxiety Disorder) scale will be realized to evaluated anxiety during post containment. | Other | coping strategy based on emotion, coping strategy based on problem |
| Big Five Inventory (BFI) scaleBig Five Inventory (BFI) will be realized to evaluated personality. | Other | coping strategy based on emotion, coping strategy based on problem |
| Relationship Scales Questionnaire (RSQ)Relationship Scales Questionnaire (RSQ) will be realized to evaluated attachment style. | Other | coping strategy based on emotion, coping strategy based on problem |
Primary outcome
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).
9 secondary outcomes
Analysis usual coping strategies measured by brief COPE (dispositional version) results
Time frame: Year: 1
Analysis of situation of patients
Time frame: Year: 1
Analysis usual coping strategies during containment measured by brief COPE (dispositional version) results
Time frame: Year: 1
Analysis anxiety during containment measured by GAD-7 (Generalized Anxiety Disorder) results
Time frame: Year: 1
Analysis anxiety related to the containment context measured by analogue scale
Time frame: Year: 1
Analysis anxiety post containment measured by GAD-7 (Generalized Anxiety Disorder) results
Time frame: Year: 1
Analysis of personalities by Big Five Inventory (BFI) scale
Time frame: Year: 1
Analysis attachment measured by Relationship Scales Questionnaire (RSQ) scale results
Time frame: Year: 1
presence of traumatic life events
Time frame: Year: 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Derived from this study: PubMed 36741567Pongan E, Rouch I, Herrmann M, Perrot C, Lebrun-Givois C, Spirli L, Briollet C, Martin HS, Laurent B, Bachelet R, El Haouari H, Buisson A, Edjolo A, Dorey JM. Anxiety symptoms during COVID-19 in older adults with psychiatric disorders. Front Psychiatry. 2023 Jan 16;13:1082807. doi: 10.3389/fpsyt.2022.1082807. eCollection 2022.
- Derived from this study: PubMed 35832598Edjolo A, Dorey JM, Herrmann M, Perrot C, Lebrun-Givois C, Buisson A, El Haouari H, Laurent B, Pongan E, Rouch I. Stress, Personality, Attachment, and Coping Strategies During the COVID-19 Pandemic: The STERACOVID Prospective Cohort Study Protocol. Front Psychiatry. 2022 Jun 27;13:918428. doi: 10.3389/fpsyt.2022.918428. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Rouch, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorder and Aging, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis post traumatic stress disorder measured by PTSD Check List (PCL) results (time frame: Year: 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04760795, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.