Identification of Markers of Post-Traumatic Stress Disorder (PTSD) Relapse
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| First Received Date ICMJE | December 8, 2011 | ||||||||||||||||||||||||
| Last Updated Date | February 20, 2013 | ||||||||||||||||||||||||
| Start Date ICMJE | October 2012 | ||||||||||||||||||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Attentional score [ Time Frame: baseline at the first visit (T0), at 6 months, at 9 months ] [ Designated as safety issue: No ] Go-No/Go and visual search tests |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT01545505 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
memory (Grober and Buschke) [ Time Frame: baseline at the first visit (T0), at 6 months, at 9 months ] [ Designated as safety issue: No ] Grober and Buschke memory tests |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||
| Brief Title ICMJE | Identification of Markers of Post-Traumatic Stress Disorder (PTSD) Relapse | ||||||||||||||||||||||||
| Official Title ICMJE | Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families | ||||||||||||||||||||||||
| Brief Summary | Relapse of post-traumatic stress disorder (PTSD) remains challenging. In addition, factors predicting PTSD relapse are still unknown. The aim of this study is to examine whether clinical and neuropsychological changes (e.g., attentional bias toward aversive cues) that characterized PTSD can be observed in people with past PTSD (children and their families) and whether these persistent changes are predictive of PTSD relapse. |
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| Detailed Description | One of the great challenges in Psychotraumatology is the high risk (20-40%) of post-traumatic stress disorder (PTSD) relapse, which markers remain understudied. Identification of these markers is of particular interest for the development of strategies to prevent relapse. Based on clinical and experimental data, it appears that (i) the so-called residual clinical symptoms (such as sleep disturbance, irritability) and (ii) the neuropsychological dysfunctions (cognitive difficulties), persisting after remission, may constitute markers of PTSD relapse. Moreover, all of these potential markers have also been linked with dysfunctions, persisting or reoccurring, in the prefrontal cortex after remission. The main objective of this study is to identify these clinical and neuropsychological markers of PTSD relapse in children and their families. The secondary objective is to demonstrate the link between prefrontal dysfunctions and relapse. This longitudinal study will include 4 experimental groups:
The psychological assessment will include: A structured interview with a psychiatrist An assessment of PTSD symptoms (IES-R, CPTS-RI for children) An assessment of the co-morbidity (STAI C and CDI for children, STAI A-B, BDI for adults). An evaluation of the social life (EAS for children and SAS-SR for adults). The neuropsychological assessment will include: An evaluation of the attentional treatment (Go-No / go and visual search) An evaluation of executive functions (TMT A and B) A brief evaluation of the IQ (items memory of figures, matrix and resemblance) An evaluation of the memory (Grober and Buschke) Tests include an adult and children versions that are validated. All studies will be conducted at the Nice University Hospital, Tours University Hospital and Toulouse University Hospital. |
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| Study Type ICMJE | Interventional | ||||||||||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Post Traumatic Stress Disorder (PTSD) | ||||||||||||||||||||||||
| Intervention ICMJE | Behavioral: Neuropsychological assessment
A clinical evaluation with Impact of Events Scale-Revised, Child Post-Traumatic Stress Reaction Index, State-Trait Anxiety Inventory for Children, Children Depression Inventory and Emotion, activity and sociability. A neuropsychological assessment with a emotional Go-No/Go, a visual search task, the Trail Making Test, 3 items of the WISC III ( and the Grober and Buschke Test. |
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| Publications * | Not Provided | ||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||||||
| Estimated Enrollment ICMJE | 120 | ||||||||||||||||||||||||
| Estimated Completion Date | July 2014 | ||||||||||||||||||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Eligibility Criteria ICMJE | For children Inclusion Criteria:
Exclusion Criteria
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| Gender | Both | ||||||||||||||||||||||||
| Ages | 9 Years to 18 Years | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||
| NCT Number ICMJE | NCT01545505 | ||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | 11-AOI-09 | ||||||||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||||||||
| Responsible Party | Centre Hospitalier Universitaire de Nice | ||||||||||||||||||||||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Nice | ||||||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire de Nice | ||||||||||||||||||||||||
| Verification Date | February 2013 | ||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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