NCT02368353

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

February 13, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

5 years

First QC Date

February 6, 2015

Last Update Submit

October 18, 2017

Conditions

Young Subjects With at Risk Mental States

Outcome Measures

Primary Outcomes (1)

  • The score at month 6 on the "positive" psychotic dimension of the CAARMS (first subscale including delusion, hallucination and disorganized thoughts).

    Month 6

Secondary Outcomes (35)

  • Score on CAARMS

    Month 0

  • Score on CAARMS

    Month 6

  • Score on CAARMS

    Month 12

  • · Rate of conversion (as defined by CAARMS)

    Month 6

  • · Rate of conversion (as defined by CAARMS)

    Month 12

  • +30 more secondary outcomes

Study Arms (2)

Cognitive behavioral therapy group

EXPERIMENTAL

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

Other: Cognitive behavioral therapy

Reference group

ACTIVE COMPARATOR

weekly supportive therapy - 1/week 3 months

Other: Supportive therapy

Interventions

Cognitive behavioral therapyOTHER
Cognitive behavioral therapy group
Supportive therapyOTHER
Reference group

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sainte Anne

Paris, 75014, France

RECRUITING

MeSH Terms

Interventions

Cognitive Behavioral TherapyPalliative Care

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Marie-Odile KREBS KREBS, MD, PhD

CONTACT

0033145658646mo.krebs@ch-sainte-anne.fr

Marie GODARD

CONTACT

0033145657728m.godard@ch-sainte-anne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2015

First Posted

February 23, 2015

Study Start

February 13, 2015

Primary Completion

February 1, 2020

Study Completion

August 1, 2020

Last Updated

October 20, 2017

Record last verified: 2017-10

Locations

FR(1)