"Stress in At Risk Mental State: Efficacy of Stress Management Cognitive Behavioral Therapy : a Randomized Controlled Trial"
NCT ID: NCT02368353
Last Updated: 2017-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2015-02-13
2020-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cognitive behavioral therapy group
weekly group stress-management CBT (SM-CBT) - 1/week 3 months
Cognitive behavioral therapy
Reference group
weekly supportive therapy - 1/week 3 months
Supportive therapy
Interventions
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Cognitive behavioral therapy
Supportive therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Years
25 Years
ALL
No
Sponsors
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Centre Hospitalier St Anne
OTHER
Responsible Party
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Locations
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Centre Hospitalier Sainte Anne
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Marie-Odile KREBS, MD, PhD
Role: primary
Marie GODARD
Role: backup
Other Identifiers
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D14-P008
Identifier Type: -
Identifier Source: org_study_id