Post Traumatic Stress Disorder (PTSD) Clinical Trial
Official title:
Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families
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.
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.
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00554177 -
A Clinical Trial for Post Traumatic Stress Disorder
|
Phase 1 | |
Completed |
NCT02966873 -
Clinical Trial for Alcohol Use Disorder and Post Traumatic Stress Disorder (PTSD)
|
Phase 2 | |
Completed |
NCT04827056 -
Effect of Sublingual Formulation of Dexmedetomidine HCl (BXCL501) - Alcohol Interaction Study
|
Phase 1 | |
Completed |
NCT04073862 -
The Norwegian Stepped-Care TF-CBT Study
|
N/A | |
Recruiting |
NCT05254379 -
Transcranial Direct Current Stimulation Treatment for Warriors Experiencing Chronic Pain
|
N/A | |
Terminated |
NCT02077972 -
Whole Body Hyperthermia & Combat-Related Posttraumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT04086654 -
Psychometric Properties of the International Trauma Interview (ITI) for ICD-11 PTSD and CPTSD
|
N/A | |
Completed |
NCT02723097 -
A Pilot Test of the Relaxation Response Resiliency Program (3RP) in Spanish Speaking World Trade Center Survivors With Post Traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT01629537 -
A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder
|
Phase 2 | |
Withdrawn |
NCT00641511 -
Pharmacogenetic Clinical Trial of Nepicastat for Post Traumatic Stress Disorder (PTSD)
|
Phase 2 | |
Recruiting |
NCT04558437 -
COVID-Impact "Psychological IMPACT of Covid-19 on AP-HP Staff"
|
||
Not yet recruiting |
NCT06162741 -
Type I Hybrid Effectiveness-Implementation Trial of Primary Care Brief Mindfulness Training for Veterans
|
N/A | |
Completed |
NCT02764983 -
Occupational Therapy Driving Intervention for Returning Combat Veterans.
|
N/A | |
Completed |
NCT02765672 -
Effectiveness of a Driving Intervention on Safe Community Mobility for Returning Combat Veterans
|
N/A | |
Not yet recruiting |
NCT06335407 -
Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study
|
Phase 1 |