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

Centre Hospitalier St Anne

Status: Unknown

Conditions: Young Subjects With at Risk Mental States

Treatments: Other: Supportive therapy; Other: Cognitive behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02368353

D14-P008

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 15 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Cognitive behavioral therapy group

Experimental group

Description:

weekly group stress-management CBT (SM-CBT) - 1/week 3 months

Treatment:

Other: Cognitive behavioral therapy

Reference group

Active Comparator group

Description:

weekly supportive therapy - 1/week 3 months

Treatment:

Other: Supportive therapy