Post Traumatic Stress DisorderOLAFNCT04470869
Impact on the OLAF Intervention to Prevent Post Traumatic Disorders During the Confinement.
A study testing Phone call in people with Post Traumatic Stress Disorder, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The investigators thought that the confinement measure took in France could induce an increase in the post traumatic syndrome in the relative of patient hospitalized in ICU during this period indeed the restricted visit and the limited interaction with ICU team are documented risk factors for PTSD in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Phone call
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2020to 12 Oct 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Contact person (defined as the person that bring a support to the patient et with who the patient had close relationship) aged from more than 18 years old of a patient hospitalized during the confinement and the restricted visited during the SARS-CoV2 pandemic. Two contact persons maximum will be included by patient.
- Affiliated to the social security
- Agreed to participated by oral consent
Who cannot join
- Physical visits permitted by the end of the confinement
- Language barrier
- Sensorial handicap (blindness or deafness) compromising the comprehension of the information
- Legal protection of adults
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Psychiatric Intervention OLAF on the Post Traumatic Disorder in the Relatives of Patients Hospitalized in Intensive Care Unit During the SARS-Cov-2 Pandemic Confinement in France.
The investigators thought that the confinement measure took in France could induce an increase in the post traumatic syndrome in the relative of patient hospitalized in ICU during this period indeed the restricted visit and the limited interaction with ICU team are documented risk factors for PTSD in this population. The investigators designed an intervention in order to prevent the effect of the confinement measures on PTSD in relatives named OLAF. In this research the investigators aimed to study the impact on this intervention on PTSD.
Read the detailed description
The hospitalization of a relative in an intensive care unit is an important stress factor for his/ her relatives and previous studies demonstrated that 33% post traumatic disorder (PTSD) following the ICU stay of their loved ones. To response to this issue specific approach have been designed to decrease the stress of the relatives named family centered care. Those approaches are based on the interaction between the ICU team and the relatives and included large time for visiting the patient in the ward. In France the restrictive measures (confinement) took to combat the SARS-CoV-2 pandemic from the 17 march 2020 impacted negatively those family centered care approach by prohibiting the visit in ICU and limiting to interaction between ICU team and relatives to phone calls. The investigators thought that this context could have for consequence an increase in relative anxiety and PTSD. The investigators designed a care intervention named OLAF in order to limit the impact of the confinement on relative psychological state. OLAF intervention permits to the two closest relatives of the patient to be contacted by a psychiatrist and could benefit from a specialized follow up. This intervention is completed by the implementation of virtual visits by video conference that were proposed to the relatives as well as video interview with the ICU team. In this study the investigators aimed to investigated the impact of this intervention to prevent the PTSD in the relatives by comparing the PTSD prevalence in a group of relatives that loved ones were hospitalized after the confinement measure but before the OLAF intervention and a group of relatives that loved ones were hospitalized during the OLAF intervention.
The relative will benefit from psychiatric interview 3 months after their loved ones leave the ICU or died to collect information by phone about the confinement situation they experiment, the satisfaction they had about the patient stay in ICU and their anxiety and depression state. Three-month, six month and twelve months after the discharge of the dead the relative information will be collected by phone about PTSD symptoms, anxiety and depression and complicated grief in case of death of the patient.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Phone call
- Keywords
- intensive care unit, confinement, SARS-CoV-2, post-traumatic stress disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone callOther
The relatives of both groups will be contacted by phone one month after the discharge of the ICU of the death, three month after, six month after and twelve month after. During these interviews the PTSD symptoms, the anxiety and depression symptoms, the complicated grief symptoms (in case of death) and the satisfaction about the ICU stay will be collected.
| Study group | Role | What they receive |
|---|---|---|
| OLAF group | Experimental | The interventional group (OLAF) benefit from a psychiatric follow up, from virtual visiting of the patient and video interview with ICU team. Receives: Other: Phone call |
| Control | Placebo comparator | The control group contains the relatives of patients hospitalized after the confinement measure but before the OLAF intervention. This group benefit from phone contact with the ICU team at the admission in ICU then two contact per week minimum to one contact per day maximum during the stay, excepting the specific phone calls associated with favorable or unfavorable evolution. Receives: Other: Phone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of PTSD observed 6 months after patient's discharge from the intensive care unit
To demonstrate the benefits of a comprehensive family approach (OLAF) on the incidence of PTSD observed in 2 close referents of a patient, 6 months after leaving the intensive care unit, in the context of confinement linked to the SARS pandemic- CoV2.
Measured: Month 6
Secondary outcomes (9)
incidence of PTSD observed 6 months after patient's death in the intensive care unit
The incidence of PTSD 6 months after patient's death in the intensive care unit
Measured: Month 6
PTSD incidence at month 3
The incidence of PTSD 3 months after the death or discharge from the intensive care unit
Measured: Month 3
PTSD incidence at month 12
The incidence of PTSD 12 months after the death or discharge from the intensive care unit
Measured: Month 12
Symptoms incidence at month 3
The incidence of symptoms of anxiety and / or depression 3 months after death or discharge from the intensive care unit
Measured: Month 3
Symptoms incidence at month 6
The incidence of symptoms of anxiety and / or depression 6 months after death or discharge from the intensive care unit
Measured: Month 6
Symptoms incidence at month 12
The incidence of symptoms of anxiety and / or depression 12 months after death or discharge from the intensive care unit
Measured: Month 12
incidence of persistent complicated grief at month 3
The incidence of persistent complicated grief 3 months after death in intensive care
Measured: Month 3
incidence of persistent complicated grief at month 6
The incidence of persistent complicated grief 6 months after death in intensive care
Measured: Month 6
incidence of persistent complicated grief at month 12
The incidence of persistent complicated grief 12 months after death in intensive care
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start12 Jun 2020
- Primary completion12 Oct 2021
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- In this study we aimed to investigated the impact of this intervention to prevent the PTSD in the relatives by comparing the PTSD prevalence in a group of relatives that loved ones were hospitalized after the confinement measure but before the OLAF intervention and a group of relatives that loved ones were hospitalized during the OLAF intervention.
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliette SALLES, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470869
- Sponsor's protocol ID
- RC31/20/0190
- Acronym
- OLAF
- Status last verified
- May 2022
- First submitted
- 3 Jul 2020
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Raymond V, Aitout C, Ducos G, Coullomb A, Ferre F, Vardon-Bounes F, Riu-Poulenc B, Seguin T, Boukhatem L, Geeraerts T, Minville V, Fourcade O, Birmes P, Arbus C, Silva S, Salles J. Effectiveness of psychiatric support for PTSD among a cohort of relatives of patients hospitalized in an intensive care unit during the French COVID-19 lockdown-The OLAF (Operation Liaison et Aide aux Familles): A quasi-randomized clinical trial. Gen Hosp Psychiatry. 2023 Sep-Oct;84:266-267. doi: 10.1016/j.genhosppsych.2023.06.009. Epub 2023 Jun 21. No abstract available.
PubMed 37357092
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Psychiatric Intervention OLAF on the Post Traumatic Disorder in the Relatives of Patients Hospitalized in Intensive Care Unit During the SARS-Cov-2 Pandemic Confinement in France.
- ClinicalTrials.gov ID
- NCT04470869
- Acronym / sponsor ID
- OLAF / RC31/20/0190
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- intensive care unit, confinement, SARS-CoV-2, post-traumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 14 Jul 2020 (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.
The investigators thought that the confinement measure took in France could induce an increase in the post traumatic syndrome in the relative of patient hospitalized in ICU during this period indeed the restricted visit and the limited interaction with ICU team are documented risk factors for PTSD in this population. The investigators designed an intervention in order to prevent the effect of the confinement measures on PTSD in relatives named OLAF. In this research the investigators aimed to study the impact on this intervention on PTSD.
Detailed description
The hospitalization of a relative in an intensive care unit is an important stress factor for his/ her relatives and previous studies demonstrated that 33% post traumatic disorder (PTSD) following the ICU stay of their loved ones. To response to this issue specific approach have been designed to decrease the stress of the relatives named family centered care. Those approaches are based on the interaction between the ICU team and the relatives and included large time for visiting the patient in the ward. In France the restrictive measures (confinement) took to combat the SARS-CoV-2 pandemic from the 17 march 2020 impacted negatively those family centered care approach by prohibiting the visit in ICU and limiting to interaction between ICU team and relatives to phone calls. The investigators thought that this context could have for consequence an increase in relative anxiety and PTSD. The investigators designed a care intervention named OLAF in order to limit the impact of the confinement on relative psychological state. OLAF intervention permits to the two closest relatives of the patient to be contacted by a psychiatrist and could benefit from a specialized follow up. This intervention is completed by the implementation of virtual visits by video conference that were proposed to the relatives as well as video interview with the ICU team. In this study the investigators aimed to investigated the impact of this intervention to prevent the PTSD in the relatives by comparing the PTSD prevalence in a group of relatives that loved ones were hospitalized after the confinement measure but before the OLAF intervention and a group of relatives that loved ones were hospitalized during the OLAF intervention.
The relative will benefit from psychiatric interview 3 months after their loved ones leave the ICU or died to collect information by phone about the confinement situation they experiment, the satisfaction they had about the patient stay in ICU and their anxiety and depression state. Three-month, six month and twelve months after the discharge of the dead the relative information will be collected by phone about PTSD symptoms, anxiety and depression and complicated grief in case of death of the patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study we aimed to investigated the impact of this intervention to prevent the PTSD in the relatives by comparing the PTSD prevalence in a group of relatives that loved ones were hospitalized after the confinement measure but before the OLAF intervention and a group of relatives that loved ones were hospitalized during the OLAF intervention.
| Arm | Type | Receives |
|---|---|---|
| OLAF group | Experimental | Other: Phone callThe interventional group (OLAF) benefit from a psychiatric follow up, from virtual visiting of the patient and video interview with ICU team. |
| Control | Placebo comparator | Other: Phone callThe control group contains the relatives of patients hospitalized after the confinement measure but before the OLAF intervention. This group benefit from phone contact with the ICU team at the admission in ICU then two contact per week minimum to one contact per day maximum during the stay, excepting the specific phone calls associated with favorable or unfavorable evolution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Contact person (defined as the person that bring a support to the patient et with who the patient had close relationship) aged from more than 18 years old of a patient hospitalized during the confinement and the restricted visited during the SARS-CoV2 pandemic. Two contact persons maximum will be included by patient.
- Affiliated to the social security
- Agreed to participated by oral consent
Key exclusion criteria (5 listed)
- Physical visits permitted by the end of the confinement
- Language barrier
- Sensorial handicap (blindness or deafness) compromising the comprehension of the information
- Legal protection of adults
- Refusal of participation
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 |
|---|---|---|
| Phone callThe relatives of both groups will be contacted by phone one month after the discharge of the ICU of the death, three month after, six month after and twelve month after. During these interviews the PTSD symptoms, the anxiety and depression symptoms, the complicated grief symptoms (in case of death) and the satisfaction about the ICU stay will be collected. | Other | Control, OLAF group |
Primary outcome
incidence of PTSD observed 6 months after patient's discharge from the intensive care unit
Time frame: Month 6
To demonstrate the benefits of a comprehensive family approach (OLAF) on the incidence of PTSD observed in 2 close referents of a patient, 6 months after leaving the intensive care unit, in the context of confinement linked to the SARS pandemic- CoV2.
9 secondary outcomes
incidence of PTSD observed 6 months after patient's death in the intensive care unit
Time frame: Month 6
PTSD incidence at month 3
Time frame: Month 3
PTSD incidence at month 12
Time frame: Month 12
Symptoms incidence at month 3
Time frame: Month 3
Symptoms incidence at month 6
Time frame: Month 6
Symptoms incidence at month 12
Time frame: Month 12
incidence of persistent complicated grief at month 3
Time frame: Month 3
incidence of persistent complicated grief at month 6
Time frame: Month 6
incidence of persistent complicated grief at month 12
Time frame: Month 12
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 1 Jun 2022.
- Derived from this study: PubMed 37357092Raymond V, Aitout C, Ducos G, Coullomb A, Ferre F, Vardon-Bounes F, Riu-Poulenc B, Seguin T, Boukhatem L, Geeraerts T, Minville V, Fourcade O, Birmes P, Arbus C, Silva S, Salles J. Effectiveness of psychiatric support for PTSD among a cohort of relatives of patients hospitalized in an intensive care unit during the French COVID-19 lockdown-The OLAF (Operation Liaison et Aide aux Familles): A quasi-randomized clinical trial. Gen Hosp Psychiatry. 2023 Sep-Oct;84:266-267. doi: 10.1016/j.genhosppsych.2023.06.009. Epub 2023 Jun 21. No abstract available.
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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.
Juliette SALLES, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone call in people with Post Traumatic Stress Disorder, run by University Hospital, Toulouse at 1 site 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 5 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 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
incidence of PTSD observed 6 months after patient's discharge from the intensive care unit (time frame: Month 6). 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 NCT04470869, which also lists 1 linked publication.
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 1 Jun 2022.