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

Study Overview
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Brief Summary
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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.

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

Conditions
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Young Subjects With at Risk Mental States

Intervention / Treatment
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* Other: Cognitive behavioral therapy
* Other: Supportive therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive behavioral therapy group<br>weekly group stress-management CBT (SM-CBT) - 1/week 3 months | Other: Cognitive behavioral therapy<br> <br> |
| Active Comparator: Reference group<br>weekly supportive therapy - 1/week 3 months | Other: Supportive therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on CAARMS |  | Month 0 | 
| Score on CAARMS |  | Month 6 | 
| Score on CAARMS |  | Month 12 | 
| · Rate of conversion (as defined by CAARMS) |  | Month 6 | 
| · Rate of conversion (as defined by CAARMS) |  | Month 12 | 
| Score on BPRS |  | Month 0 | 
| Score on BPRS |  | Month 6 | 
| Score on BPRS |  | Month 12 | 
| Score on MADRS |  | Month 0 | 
| Score on MADRS |  | Month 6 | 
| Score on MADRS |  | Month 12 | 
| Score on YMRS |  | Month 0 | 
| Score on YMRS |  | Month 6 | 
| Score on YMRS |  | Month 12 | 
| Score on SOFAS |  | Month 0 | 
| Score on SOFAS |  | Month 6 | 
| Score on SOFAS |  | Month 12 | 
| Stress marker : saliva cortisol level |  | Month 0 | 
| Stress marker : saliva cortisol level |  | Month 6 | 
| Stress marker : saliva cortisol level |  | Month 12 | 
| Stress marker : telomerase activity |  | Month 0 | 
| Stress marker : telomerase activity |  | Month 6 | 
| Stress marker : telomerase activity |  | Month 12 | 
| Stress marker : epigenetic markers |  | Month 0 | 
| Stress marker : epigenetic markers |  | Month 6 | 
| Stress marker : epigenetic markers |  | Month 12 | 
| Stress marker : genetic variants that modulate stress response |  | Month 0 | 
| Stress marker : genetic variants that modulate stress response |  | Month 6 | 
| Stress marker : genetic variants that modulate stress response |  | Month 12 | 
| Stress marker : hippocampal volume |  | Month 0 | 
| Stress marker : hippocampal volume |  | Month 12 | 
| Performance score on autobiographic memory |  | Month 0 | 
| Performance score on autobiographic memory |  | Month 12 | 
| Performance score on sense of self tasks |  | Month 0 | 
| Performance score on sense of self tasks |  | Month 12 |