"Stress in At Risk Mental State: Efficacy of Stress Management Cognitive Behavioral Therapy : a Randomized Controlled Trial"

Centre Hospitalier St Anne120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Young Subjects With at Risk Mental States

Interventions

Eligibility

Sex: ALLMin age: 15 YearsMax age: 25 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The score at month 6 on the "positive" psychotic dimension of the CAARMS (first subscale including delusion, hallucination and disorganized thoughts).

Time frame: Month 6

Secondary Outcomes

Score on CAARMS

Time frame: Month 0

Score on CAARMS

Time frame: Month 6

Score on CAARMS

Time frame: Month 12

· Rate of conversion (as defined by CAARMS)

Time frame: Month 6

· Rate of conversion (as defined by CAARMS)

Time frame: Month 12

Score on BPRS

Time frame: Month 0

Score on BPRS

Time frame: Month 6

Score on BPRS

Time frame: Month 12

Score on MADRS

Time frame: Month 0

Score on MADRS

Time frame: Month 6

Score on MADRS

Time frame: Month 12

Score on YMRS

Time frame: Month 0

Score on YMRS

Time frame: Month 6

Score on YMRS

Time frame: Month 12

Score on SOFAS

Time frame: Month 0

Score on SOFAS

Time frame: Month 6

Score on SOFAS

Time frame: Month 12

Stress marker : saliva cortisol level

Time frame: Month 0

Stress marker : saliva cortisol level

Time frame: Month 6

Stress marker : saliva cortisol level

Time frame: Month 12

Stress marker : telomerase activity

Time frame: Month 0

Stress marker : telomerase activity

Time frame: Month 6

Stress marker : telomerase activity

Time frame: Month 12

Stress marker : epigenetic markers

Time frame: Month 0

Stress marker : epigenetic markers

Time frame: Month 6

Stress marker : epigenetic markers

Time frame: Month 12

Stress marker : genetic variants that modulate stress response

Time frame: Month 0

Stress marker : genetic variants that modulate stress response

Time frame: Month 6

Stress marker : genetic variants that modulate stress response

Time frame: Month 12

Stress marker : hippocampal volume

Time frame: Month 0

Stress marker : hippocampal volume

Time frame: Month 12

Performance score on autobiographic memory

Time frame: Month 0

Performance score on autobiographic memory

Time frame: Month 12

Performance score on sense of self tasks

Time frame: Month 0

Performance score on sense of self tasks

Time frame: Month 12

"Stress in At Risk Mental State: Efficacy of Stress Management Cognitive Behavioral Therapy : a Randomized Controlled Trial"

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts