Stress in At Risk Mental State: Efficacy of Stress Management Cognitive Behavioral Therapy : a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- The score at month 6 on the "positive" psychotic dimension of the CAARMS (first subscale including delusion, hallucination and disorganized thoughts).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Cognitive behavioral therapy group
weekly group stress-management CBT (SM-CBT) - 1/week 3 months
Intervention: Cognitive behavioral therapy (Other)
Reference group
weekly supportive therapy - 1/week 3 months
Intervention: Supportive therapy (Other)
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
- Performance score on autobiographic memory(Month 12)
- Score on CAARMS(Month 12)
- · Rate of conversion (as defined by CAARMS)(Month 12)
- Score on YMRS(Month 12)
- Stress marker : genetic variants that modulate stress response(Month 12)
- Score on BPRS(Month 12)
- Score on MADRS(Month 12)
- Stress marker : saliva cortisol level(Month 12)
- Stress marker : telomerase activity(Month 12)
- Performance score on sense of self tasks(Month 12)
- Score on SOFAS(Month 12)
- Stress marker : epigenetic markers(Month 12)
- Stress marker : hippocampal volume(Month 12)