Status:

UNKNOWN

Treating Early Stages With an Intervention Targeting Cognitive Reserve

Lead Sponsor:

Hospital Clinic of Barcelona

Conditions:

Psychotic Disorder

Eligibility:

All Genders

12-45 years

Phase:

NA

Brief Summary

This study proposes continuity in the implementation of a psychological approach program to enhance cognitive reserve (CR) in children, adolescent and young adults, off-springs of patients with schizo...

Detailed Description

The study will include a sample of High Genetic Risk-SZBD (HR-SZBD) subjects (N = 60), First Episode Psychotic Patients (FEP) (N = 60) and CC participants (N = 60). All groups will be evaluated with C...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • \- Inclusion criteria for the Off-SZBP will be: Subjects between 12 and 25 years with a parent (mother or father) diagnosed with bipolar disorder or schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria.
  • \- Inclusion criteria for patients with a first affective (mania or depression with or without psychotic symptoms and hypomania) or non-affective episode (first psychotic episode) will be:
  • Patients between 12 and 45 years with a first affective or non-affective episode within the last 5 years.
  • Diagnosis of bipolar disorder, schizophrenia, schizoaffective disorders and other psychoses according to DSM-5 criteria based on a semi-structured clinical interview.
  • Patients in full or partial clinical remission at the moment of assessment, defined as scores ≤ 10 in Young Mania Rating Scale (YMRS) (Young, 1978) and ≤ 14 scores in the Hamilton Depression Rating Scale (Hamilton, 1960).
  • Scores lower or equal to 3 during the previous two months in symptoms P1 (delusions), G9 (unusual thought content), P3 (hallucinations), P2 (conceptual disorganization), G5 (mannerisms and posturing), N1 (blunted affect), N4 (social withdrawal) and N6 (spontaneity and flow of conversation) on the scale for positive and negative schizophrenia syndrome (PANSS).
  • \- Inclusion criteria for Community Control:s (CC) Children, adolescents and young adults between 12 and 45 years old without history of psychotic disorder or bipolar disorder in first degree relatives.
  • Exclusion criteria, common to all participants, will be:
  • Estimated Intelligence quotient \< 70.
  • Any medical condition that could affect neuropsychological performance (such as neurological diseases) or history of head trauma with loss of consciousness.
  • To have participated in any structured psychosocial intervention within the past 6 months.

Exclusion

    Key Trial Info

    Start Date :

    January 1 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    January 1 2023

    Estimated Enrollment :

    180 Patients enrolled

    Trial Details

    Trial ID

    NCT05288049

    Start Date

    January 1 2021

    End Date

    January 1 2023

    Last Update

    March 18 2022

    Active Locations (1)

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    1

    Hospital Clinic

    Barcelona, Spain, 08036