- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02368353
"Stress in At Risk Mental State: Efficacy of Stress Management Cognitive Behavioral Therapy : a Randomized Controlled Trial" (START)
Stress in At Risk Mental State: Efficacy of Stress Management Cognitive Behavioral Therapy : a Randomized Controlled Trial
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marie GODARD
- Phone Number: 0033145657728
- Email: m.godard@ch-sainte-anne.fr
Study Contact Backup
- Name: Marie-Odile KREBS KREBS, MD, PhD
- Phone Number: 0033145658646
- Email: mo.krebs@ch-sainte-anne.fr
Study Locations
-
-
-
Paris, France, 75014
- Recruiting
- Centre hospitalier Sainte Anne
-
Contact:
- Marie GODARD
- Phone Number: 0033145657728
- Email: m.godard@ch-sainte-anne.fr
-
Contact:
- Marie-Odile KREBS, MD, PhD
- Phone Number: 00331 45 65 86 46
- Email: mo.krebs@ch-sainte-anne.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive behavioral therapy group
weekly group stress-management CBT (SM-CBT) - 1/week 3 months
|
|
Active Comparator: Reference group
weekly supportive therapy - 1/week 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Month 6
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Score on CAARMS
Time Frame: Month 0
|
Month 0
|
Score on CAARMS
Time Frame: Month 6
|
Month 6
|
Score on CAARMS
Time Frame: Month 12
|
Month 12
|
· Rate of conversion (as defined by CAARMS)
Time Frame: Month 6
|
Month 6
|
· Rate of conversion (as defined by CAARMS)
Time Frame: Month 12
|
Month 12
|
Score on BPRS
Time Frame: Month 0
|
Month 0
|
Score on BPRS
Time Frame: Month 6
|
Month 6
|
Score on BPRS
Time Frame: Month 12
|
Month 12
|
Score on MADRS
Time Frame: Month 0
|
Month 0
|
Score on MADRS
Time Frame: Month 6
|
Month 6
|
Score on MADRS
Time Frame: Month 12
|
Month 12
|
Score on YMRS
Time Frame: Month 0
|
Month 0
|
Score on YMRS
Time Frame: Month 6
|
Month 6
|
Score on YMRS
Time Frame: Month 12
|
Month 12
|
Score on SOFAS
Time Frame: Month 0
|
Month 0
|
Score on SOFAS
Time Frame: Month 6
|
Month 6
|
Score on SOFAS
Time Frame: Month 12
|
Month 12
|
Stress marker : saliva cortisol level
Time Frame: Month 0
|
Month 0
|
Stress marker : saliva cortisol level
Time Frame: Month 6
|
Month 6
|
Stress marker : saliva cortisol level
Time Frame: Month 12
|
Month 12
|
Stress marker : telomerase activity
Time Frame: Month 0
|
Month 0
|
Stress marker : telomerase activity
Time Frame: Month 6
|
Month 6
|
Stress marker : telomerase activity
Time Frame: Month 12
|
Month 12
|
Stress marker : epigenetic markers
Time Frame: Month 0
|
Month 0
|
Stress marker : epigenetic markers
Time Frame: Month 6
|
Month 6
|
Stress marker : epigenetic markers
Time Frame: Month 12
|
Month 12
|
Stress marker : genetic variants that modulate stress response
Time Frame: Month 0
|
Month 0
|
Stress marker : genetic variants that modulate stress response
Time Frame: Month 6
|
Month 6
|
Stress marker : genetic variants that modulate stress response
Time Frame: Month 12
|
Month 12
|
Stress marker : hippocampal volume
Time Frame: Month 0
|
Month 0
|
Stress marker : hippocampal volume
Time Frame: Month 12
|
Month 12
|
Performance score on autobiographic memory
Time Frame: Month 0
|
Month 0
|
Performance score on autobiographic memory
Time Frame: Month 12
|
Month 12
|
Performance score on sense of self tasks
Time Frame: Month 0
|
Month 0
|
Performance score on sense of self tasks
Time Frame: Month 12
|
Month 12
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- D14-P008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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