Clinical Trials Logo

Clinical Trial Summary

The high hereditary component and the contribution of neurodevelopmental processes in bipolar disorder and schizophrenia means implies the children of these patients are considered a high risk population for both diseases and therefore a very adequate sample for the study of vulnerability markers to both disorders. To date there is no previous literature on the psychological approach of children and adolescents of bipolar or schizophrenic patients. The concept of cognitive reserve (CR) was initially developed in the field of dementia, it assumes that people with the same brain damage may have different clinical manifestations depending on their ability to compensate for this damage, so a greater cognitive reserve will entail a greater capacity to compensate the alterations and difficulties due to the pathology. Enhancing CR in high genetic risk population could help the acquisition of skills that help compensate the clinical, cognitive and neuroimaging alterations and ultimately help in the prevention of the development of pathologies for those with higher risk.This study aims to develop and apply a psychological program in order to enhance cognitive reserve (CR) in child, adolescent and young adults offspring of patients diagnosed with schizophrenia or bipolar disorder (SZBP-OFF).


Clinical Trial Description

The project will have two main objectives: to test the effectiveness of the psychological program and to test if the observed improvements are stable over time (nine months of follow-up). A sample of 108 SZBP-OFF and 52 community controls will be included. Both groups will be assessed with clinical scales, neuropsychological, CR and neuroimaging assessments at baseline. Then, the SZBP-OFF group will be randomized to psychological program to enhance CR (N= 54) or to support treatment (N=54). SZBP-OFF subjects will be evaluated with clinical, CR, neuropsychological and neuroimaging tests after the psychological intervention and at nine months follow-up in order to assess if the obtained results are stable over time. The investigators hypothesize that SZBP-OFF will show lower CR scores and higher percentages of psychopathology, cognitive difficulties and brain abnormalities. The investigators also hypothesize that SZBP-OFF who received the psychological intervention will increase their CR and will decrease the severity of the observed difficulties (in clinical, neuropsychological, CR and neuroimaging areas). These results will be stable in the nine month follow-up assessment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03722082
Study type Interventional
Source Hospital Clinic of Barcelona
Contact Carla Torrent, Dr
Phone 932275400
Email ctorrent@clinic.ub.es
Status Recruiting
Phase N/A
Start date October 1, 2018
Completion date June 2022

See also
  Status Clinical Trial Phase
Recruiting NCT06408012 - An Innovative Master Platform for Clinical Trials in Mood Disorders
Completed NCT05601063 - Ascertaining Diagnosis Classification With Elicited Speech
Recruiting NCT06002204 - Studying the Health of Asians to Advance Knowledge, Treatments, and Interventions for Depression
Not yet recruiting NCT05705063 - Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar Illness N/A
Completed NCT03152032 - Employment Outcomes After Vocational Training N/A