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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01200628
Other study ID # 2006_0632
Secondary ID DGS 2006-0053PHR
Status Completed
Phase N/A
First received March 18, 2010
Last updated June 16, 2015
Start date June 2007
Est. completion date June 2015

Study information

Verified date June 2015
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority France: Direction Générale de la Santé
Study type Observational

Clinical Trial Summary

Posttraumatic stress disorder (PTSD) is a serious and often chronic response to overwhelmingly stressful events as Road Traffic Accident. Moreover PTSD is associated with increased rates of medical morbidity, poor health-related quality of life, and functional impairment. PTSD is prevalent in primary care settings after road traffic accident, where approximately 25% of patients meet diagnostic criteria for the disorder. Despite the development of a number of efficacious behavioral and pharmacological treatments, only a minority of patients with PTSD receive mental health services. PTSD is frequently underrecognized and untreated in Emergency Department and Surgical Unit.

Then, early diagnosis and prevention of PTSD might help to identify patients with PTSD high risk and lead them to benefit of personalized cares. Nevertheless it is not possible (neither useful) to provide psychological cares for each road traffic accident victim.

This is the reason why we think that nurses can help to screen patients who need treatment for PTSD Hypothesis : Recognition of specific clinical or biological signs occurring during road traffic accident victim hospitalization in surgical unit could allow beginning specific treatment using consultation liaison psychiatry.

Early treatment could allow decreasing incidence of psychotraumatic disorders, increasing surgical functional efficacy and improve convalescence programs. The use of a specific questionnaire could help to screen this disorder.

We have created the DEPITAC scale : a short screening questionnaire with 10 items.

This study will be evaluated DEPITAC's 10-item screen for posttraumatic stress disorder (PTSD) for use in surgical or emergency department.


Description:

We include 300 road traffic accident victims hospitalized in surgical department (less than 2 weeks). Patients are hospitalized in 5 different hospitals (3 in Lille, 1 in Douai, 1 in Paris). Patients will be evaluated by a short screening questionnaire (DEPITAC's 10 item screen). Patients will be evaluated by phone with a experimented psychologist (Minimal International Neuropsychiatric Interview DSM IV, PTSD Check List symptoms) at 6 weeks, 6 months and 1 year after the accident.

Purposes :

- To evaluate DEPITAC's 10-item screen for posttraumatic stress disorder (PTSD) for use in surgical or emergency department.

- To measure prognosis value of DEPITAC's 10 item screen on acute PTSD (PTSD Check List symptoms (PCLs) 6th week) and late PTSD (PTSD Check List symptoms (PCLs) 6 months and 1 year) or other psychiatric disorder (anxiety, depression or addictive disorder) (Minimal International Neuropsychiatric Interview MINI DSM IV at 6 months and 1 year).

- To compare DEPITAC to Peritraumatic Distress Inventory (PDI) given a the same time.

- To calculate DEPITAC's total score and correlate to the onset of a PTSD at 6 week, 6 months and 1 year.


Recruitment information / eligibility

Status Completed
Enrollment 274
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Road traffic accident victims hospitalized in surgical department less than 2 weeks

- Can be called by phone

Exclusion Criteria:

- Patient with a coma for more than 15 minutes

- Patient with a crania traumatism and with loss of consciousness over 15 minutes

- Homeless

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Behavioral:
DEPITAC
heteroevaluation scale by a nurse during hospitalization

Locations

Country Name City State
France General Hospital, Douai Douai
France University Hospital, Grenoble Grenoble
France Catholic University Hospital of Lille Saint Philibert Lille
France Catholic University Hospital of Lille Saint Vincent Lille
France University Hospital, Lille Lille North
France Georges Pompidou European Hospital, Paris Paris

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary DEPITAC's 10 item screen score total score of DEPITAC scale six months No
Secondary Peritraumatic Distress Inventory (PDI) results six months / one year No
Secondary MINI DSM IV results Minimal International Neuropsychiatric Interview DSM IV six months / one year No
Secondary PTSD Check List symptoms results six months / one year No
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