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

October 18, 2017 updated by: Centre Hospitalier St Anne

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

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2015

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

February 6, 2015

First Submitted That Met QC Criteria

February 16, 2015

First Posted (Estimate)

February 23, 2015

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 18, 2017

Last Verified

October 1, 2017

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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