Enhancing Cognitive Reserve of the Offsprings of Bipolar and Schizophrenic Patients

Not Applicable

• Conditions: Bipolar and Related Disorders

• Registration Number: NCT03722082
• Lead Sponsor: Hospital Clinic of Barcelona

Brief 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).

Detailed 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 Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-26
• Primary Completion: 2022-02-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-05
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

Not provided

Exclusion Criteria

• Mental retardation with impaired functioning and presence of neurological disorder or history of traumatic brain injury with loss of consciousness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive reserve	3 months afther the intervention and 12 months after baseline	Changes in cognitive reserve assessed with a specific scale which assesses the most common proposed proxy indicators such as education-occupation' which is assessed taking into account the number of years of obligatory education that subjects completed and parent's educational level; and the lifetime school performance and lifetime participation in leisure, social and physical activities.

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HDRS-21)	After the intervention (3 months) and 1 year after baseline	Scale to assess depression symptoms. Score between 0 to 7 indicates absence of depressive symptoms, hihher scores indicate more severe depression.
Young Mania Rating Scale (YMRS)	After the intervention (3 months) and 1 year after baseline	The YMRS is a rating scale used to evaluate manic symptoms at baseline and over time in individuals with mania. Scores superior to 12 indicate presence of manic episodes. Higher scores indicate more severe mania.
Neuroimage variables	After the intervention (3 months)	Changes in white and grey matter. Measure will be performed with a MRI
Continuous Performance Test	After the intervention (3 months) and 12 months after baseline	Sustained attention test
Stroop Test	After the intervention (3 months) and 12 months after baseline	Executive function test (inhibit interference)
Bipolar Prodrome Symptom Interview and Scale_Prospective (BPSS_FP)	12 months after baseline	It is a specific interview for emerging bipolar disorder symptoms.
Wisconsin Card Sorting Test	After the intervention (3 months) and 12 months after baseline	Executive function test (set-shifting, flexibility)

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Spain