Young Subjects With at Risk Mental States
Conditions
Brief summary
The first psychotic episodes are preceded by a pauci-symptomatic phase from 2 to 4 years during which the psychotic symptoms are present at a subliminal level in severity or in frequency. The clinical criteria mental status with risk (AR) identifies patients among whom 10 in 40 % will make a psychotic transition in the year. Our hypothesis is that interventions to reduce reactivity to stress are effective in reducing the intensity of psychotic symptoms in subjects with prodromal psychotic symptoms. Our project is to evaluate a therapy for stress management in at risk patients, compared to a conventional monitoring, and implement a longitudinal follow-up concerning the reduction of psychotic symptoms in conjunction with other markers of stress. Nonstigmatizing, these interventions offer an alternative to antipsychotics all the more interesting since they should also reduce the risk of depression and suicide.
Interventions
OTHERCognitive behavioral therapy
OTHERSupportive therapy
Sponsors
Centre Hospitalier St Anne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Aged 15 to 25 years * Help-seekers in one of the specialized clinics for adolescents or young adults 9 * Meets CAARMS criteria for 'at risk mental state' (ARMS)
Exclusion criteria
* situations of emergency. * prengnancy, breast-feeding * Forced hospitalization or individuals under legal guardianship. * schizophrenia (DSMIV-TR criteria) * Low IQ (\<70) , * Mother tongue and primary educational language other than French * Blindness, deafness, muteness, sensorimotor or language deficits * any severe medical condition, * Daily cannabis use in the last week * Current depression (\>20 MADRS scale) * Substance dependence or abuse (except nicotine) for more than 5 years. * Treatments by benzodiazépine (\> 10 mg amount diazépam) or stop of less than 5 days * Previous treatment by antipsychotics in a superior dose in more than 100 mg equivalent Chlorpromazine if at least a sequence lasted more than 12 weeks * Treatment by antipsychotics measures \> 100 mg eq. CPZactuel (superior dose in more than 100 mg equivalent Chlorpromazine) so introduced for less than three weeks * Antidepressant treatmentsbegun for less three weeks * Treatment by corticoids (except local treatment) * Exclusion period of another study; * The usual contraindications for MRI * Absence of social insurance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The score at month 6 on the positive psychotic dimension of the CAARMS (first subscale including delusion, hallucination and disorganized thoughts). | Month 6 |
Secondary
| Measure | Time frame |
|---|---|
| · Rate of conversion (as defined by CAARMS) | Month 6 |
| Score on BPRS | Month 0 |
| Score on MADRS | Month 0 |
| Score on YMRS | Month 0 |
| Score on SOFAS | Month 0 |
| Stress marker : saliva cortisol level | Month 0 |
| Score on CAARMS | Month 0 |
| Stress marker : epigenetic markers | Month 0 |
| Stress marker : genetic variants that modulate stress response | Month 0 |
| Stress marker : hippocampal volume | Month 0 |
| Performance score on autobiographic memory | Month 0 |
| Performance score on sense of self tasks | Month 0 |
| Stress marker : telomerase activity | Month 0 |
Countries
France
Contacts
Primary ContactMarie-Odile KREBS KREBS, MD, PhD
Backup ContactMarie GODARD
Outcome results
None listed