Clinical trial NCT02368353: "Stress in At Risk Mental State: Efficacy of Stress Management Cognitive Behavioral Therapy : a Randomized Controlled Trial"
Official title: Stress in At Risk Mental State: Efficacy of Stress Management Cognitive Behavioral Therapy : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Young Subjects With at Risk Mental States
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The score at month 6 on the "positive" psychotic dimension of the CAARMS (first subscale including delusion, hallucination and disorganized thoughts).
timeFrame: Month 6
Secondary outcomes:
measure: Score on CAARMS
timeFrame: Month 0
measure: Score on CAARMS
timeFrame: Month 6
measure: Score on CAARMS
timeFrame: Month 12
measure: · Rate of conversion (as defined by CAARMS)
timeFrame: Month 6
measure: · Rate of conversion (as defined by CAARMS)
timeFrame: Month 12
measure: Score on BPRS
timeFrame: Month 0
measure: Score on BPRS
timeFrame: Month 6
measure: Score on BPRS
timeFrame: Month 12
measure: Score on MADRS
timeFrame: Month 0
measure: Score on MADRS
timeFrame: Month 6
measure: Score on MADRS
timeFrame: Month 12
measure: Score on YMRS
timeFrame: Month 0
measure: Score on YMRS
timeFrame: Month 6
measure: Score on YMRS
timeFrame: Month 12
measure: Score on SOFAS
timeFrame: Month 0
measure: Score on SOFAS
timeFrame: Month 6
measure: Score on SOFAS
timeFrame: Month 12
measure: Stress marker : saliva cortisol level
timeFrame: Month 0
measure: Stress marker : saliva cortisol level
timeFrame: Month 6
measure: Stress marker : saliva cortisol level
timeFrame: Month 12
measure: Stress marker : telomerase activity
timeFrame: Month 0
measure: Stress marker : telomerase activity
timeFrame: Month 6
measure: Stress marker : telomerase activity
timeFrame: Month 12
measure: Stress marker : epigenetic markers
timeFrame: Month 0
measure: Stress marker : epigenetic markers
timeFrame: Month 6
measure: Stress marker : epigenetic markers
timeFrame: Month 12
measure: Stress marker : genetic variants that modulate stress response
timeFrame: Month 0
measure: Stress marker : genetic variants that modulate stress response
timeFrame: Month 6
measure: Stress marker : genetic variants that modulate stress response
timeFrame: Month 12
measure: Stress marker : hippocampal volume
timeFrame: Month 0
measure: Stress marker : hippocampal volume
timeFrame: Month 12
measure: Performance score on autobiographic memory
timeFrame: Month 0
measure: Performance score on autobiographic memory
timeFrame: Month 12
measure: Performance score on sense of self tasks
timeFrame: Month 0
measure: Performance score on sense of self tasks
timeFrame: Month 12
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Hospitalier Sainte Anne
Study officials:
References: