Identification of Markers of Post-Traumatic Stress Disorder (PTSD) Relapse

Centre Hospitalier Universitaire de Nice

Status: Unknown

Conditions: Post Traumatic Stress Disorder (PTSD)

Treatments: Behavioral: Neuropsychological assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT01545505

11-AOI-09

Details and patient eligibility

About

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.

Full 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:

• 30 children with PTSD
• 30 children with past PTSD (children in remission)
• 30 parents of children with PTSD
• 30 parents of children with past PTSD The first visit is planned during the symptomatic phase (T0). The second visit (T1) is planned at the end of the symptomatic phase (or 6 months later T0). The last visit is planned 3-months after T1.

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 9 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For children

Inclusion Criteria:

• Children (9/18 years)
• Patients who have lived a traumatic event (physical assault and road accident) and who have a PTSD.
• French speaker.
• Participants must sign the informed consent and they must be affiliated to the social insurance.

Exclusion Criteria

• Children who have a neurological pathology.
• Children who have brain damage or brain-injured
• Subject having participated in a biomedical research in three months preceding the inclusion

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

In remission phase of PTSD

Other group

Description:

Patients having suffered from PTSD in the past and in remission od PTSD and their parents

Treatment:

Behavioral: Neuropsychological assessment

Activ PTSD

Other group

Description:

patients suffering from PTSD (Post-traumatic Stress Disorder) and their parents

Treatment:

Behavioral: Neuropsychological assessment