Predictability of the Clinical Global Impression Scale (CGI) in Post Immediate in Psychotraumatic Impact

NCT05358067 | Recruiting

• 1 other identifier: 2021-02
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 5

Brief Summary

The objective of this study is to evaluate correlation between Clinical Global Impression Scale (CGI) score immediately in patients who have experienced psychotrauma and occurrence of posttraumatic stress disorder at distance from traumatic event. This could allow, in future, implementation of a systematic telephone reminder of psychotraumatized patients when they have a high score on the CGI scale, and thus detect onset of a stress disorder as early as possible, post-traumatic and orientation of these patients on specialized care.

Conditions

Post-traumatic Stress Disorder

Keywords

Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Psychometric properties of the CGI as a predictor of occurrence of post-traumatic stress disorder

  Clinical Global Impression Scale (CGI) severity item provided with a seven-point scale of severity of patient's clinical condition (1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.)

  inclusion

Secondary Outcomes (9)

• Correlation between CGI score and Peritraumatic Distress Inventory scale score (PDI)

  Inclusion

• Correlation coefficient between CGI score and PCL 5 score at 1 month.

  1 month

• Correlation coefficient between CGI score and PCL 5 score at 6 months.

  6 months

• Presence/absence of a major depressive episode at 1 month in connection with traumatic event

  1 month

• Presence/absence of a major depressive episode at 6 months in connection with traumatic event

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who has experienced a traumatic event in the last 48 hours All patients meeting the inclusion criteria will be identified by the staff of the CUMP (medico-psychological emergency unit) either during an intervention (in the emergency department or outside) or during a psychiatric consultation at the emergencies

You may qualify if:

• Patient who has experienced a traumatic event in the last 48 hours;
• Patient speaking French;

You may not qualify if:

• Patient participating in another clinical trial on the treatment of his psychotraumatic experience.
• Person deprived of liberty (prisoners, defendants);
• Persons under legal protection (protected adults: under guardianship, curatorship, etc.);
• Opposition of the patient to participate in the research.

Sponsors & Collaborators

• Centre Hospitalier Arras: lead
• F2RSM Psy (Hauts-de-France Regional Federation for Research in Psychiatry and Mental Health): collaborator

Study Sites (5)

Arras General Hospital

Arras, 62000, France

RECRUITING

Arras General Hospital

Arras, 62000, France

RECRUITING

Douai General Hospital

Douai, 59507, France

RECRUITING

Lens General Hospital

Lens, 62300, France

NOT YET RECRUITING

Lille University Hospital

Lille, 59000, France

RECRUITING

Related Publications (5)

• Vaiva G, Jehel L, Cottencin O, Ducrocq F, Duchet C, Omnes C, Genest P, Rouillon F, Roelandt JL. [Prevalence of trauma-related disorders in the French WHO study: Sante mentale en population generale (SMPG)]. Encephale. 2008 Dec;34(6):577-83. doi: 10.1016/j.encep.2007.11.006. Epub 2008 Apr 2. French.

  PMID: 19081454 BACKGROUND

• Kilpatrick DG. The DSM-5 got PTSD right: comment on Friedman (2013). J Trauma Stress. 2013 Oct;26(5):563-6. doi: 10.1002/jts.21844.

  PMID: 24151004 BACKGROUND

• Pietrzak RH, Goldstein RB, Southwick SM, Grant BF. Prevalence and Axis I comorbidity of full and partial posttraumatic stress disorder in the United States: results from Wave 2 of the National Epidemiologic Survey on Alcohol and Related Conditions. J Anxiety Disord. 2011 Apr;25(3):456-65. doi: 10.1016/j.janxdis.2010.11.010. Epub 2010 Nov 26.

  PMID: 21168991 BACKGROUND

• Vance MC, Kovachy B, Dong M, Bui E. Peritraumatic distress: A review and synthesis of 15 years of research. J Clin Psychol. 2018 Sep;74(9):1457-1484. doi: 10.1002/jclp.22612. Epub 2018 Mar 15.

  PMID: 29543336 BACKGROUND

• Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.

  PMID: 20526405 BACKGROUND

Related Links

• La CUMP au-delà de l'évènement : rappel téléphonique des rapatriés du Liban, 2006
• Quand traiter le psychotraumatisme ?

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kathleen JACQUEZ, MSC

CONTACT

03 21 21 15 99; kathleen.jacquez@gh-artoisternois.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: May 3, 2022
• Study Start: October 24, 2022
• Primary Completion (Estimated): November 24, 2026
• Study Completion (Estimated): April 24, 2027
• Last Updated: July 8, 2024

Record last verified: 2024-02

Locations

FR (5)