Impact on the OLAF Intervention to Prevent Post Traumatic Disorders During the Confinement.

NCT04470869 | Completed

• 1 other identifier: RC31/20/0190
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Post Traumatic Stress Disorder

Keywords

intensive care unit; confinement; SARS-CoV-2; post-traumatic stress disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Month 6

Secondary Outcomes (9)

• incidence of PTSD observed 6 months after patient's death in the intensive care unit

  Month 6

• PTSD incidence at month 3

  Month 3

• PTSD incidence at month 12

  Month 12

• Symptoms incidence at month 3

  Month 3

• Symptoms incidence at month 6

  Month 6

Study Arms (2)

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.

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.

Other: Phone call

Interventions

Phone call OTHER

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.

Control; OLAF group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, Occitanie, 31000, France

Location

Related Publications (1)

• 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.

  PMID: 37357092 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Juliette SALLES, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 14, 2020
• Study Start: June 12, 2020
• Primary Completion: October 12, 2021
• Study Completion: October 12, 2021
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

FR (1)