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

Last updated: October 18, 2017
Sponsor: Centre Hospitalier St Anne
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02368353
D14-P008
  • Ages 15-25
  • All Genders

Study 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

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

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 equivalentChlorpromazine if at least a sequence lasted more than 12 weeks

  • Treatment by antipsychotics measures > 100 mg eq. CPZactuel (superior dose in morethan 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

Study Design

Total Participants: 120
Study Start date:
February 13, 2015
Estimated Completion Date:
August 31, 2020

Connect with a study center

  • Centre Hospitalier Sainte Anne

    Paris, 75014
    France

    Active - Recruiting

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