Enhancing Cognitive Reserve of the Offsprings of Bipolar and Schizophrenic Patients

Bipolar and Related Disorders Clinical Trial

Official title:

Study About the Effectiveness of Enhancing Cognitive Reserve in Children, Adolescents and Young Adults at Genetic Risk for Psychosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03722082
• Other study ID #: PI17/01066 and PI/1700741
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: June 2022

Study information

• Verified date: May 2022
• Source: Hospital Clinic of Barcelona
• Contact: Carla Torrent, Dr
• Phone: 932275400
• Email: ctorrent[@]clinic.ub.es
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 173
• Est. completion date: June 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 25 Years

Eligibility

Inclusion Criteria (Off-spring of patients) Inclusion criteria (Offsprings)

• Children, adolescents or young adults of both genders aged from 6 to 25, with the father and / or mother with schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-IV criteria.

• Informed consent signed by their parents or legal guardians by adolescents if they are under 12 years old.

Inclusion criteria (Controls)

• Children, adolescents or young adults of both genders between the ages of 6 and 25 years.

• No history of psychotic disorder or bipolar disorder in first and second degree relatives.

• Consent signed by the parents or legal guardians if they are under 12 years old.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bipolar and Related Disorders

Intervention

Behavioral:
• Enhancing Cognitive Reserve
The intervention is aimed at improving cognitive reserve in offsprings of patients diagnosed with schizophrenia or bipolar disorder. The program is composed of 12 sessions of 60 minutes and will be adapted according the three different age groups (6-12) (13-18) (18-25). Each group will include between 6-to-8 offsprings and conducted by 4 experienced neuropsychologists in both children and adults. The sessions are the following:
• Support intervention
The support group will schedule meetings with the participants in order to talk about their daily life with the possibility to talk about the difficulties they encounter.

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Consorcio Centro de Investigación Biomédica en Red, M.P., Institut d'Investigacions Biomèdiques August Pi i Sunyer, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive reserve	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.	3 months afther the intervention and 12 months after baseline
Secondary	Hamilton Depression Rating Scale (HDRS-21)	Scale to assess depression symptoms. Score between 0 to 7 indicates absence of depressive symptoms, hihher scores indicate more severe depression.	After the intervention (3 months) and 1 year after baseline
Secondary	Young Mania Rating Scale (YMRS)	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.	After the intervention (3 months) and 1 year after baseline
Secondary	Bipolar Prodrome Symptom Interview and Scale_Prospective (BPSS_FP)	It is a specific interview for emerging bipolar disorder symptoms.	12 months after baseline
Secondary	Continuous Performance Test	Sustained attention test	After the intervention (3 months) and 12 months after baseline
Secondary	Wisconsin Card Sorting Test	Executive function test (set-shifting, flexibility)	After the intervention (3 months) and 12 months after baseline
Secondary	Stroop Test	Executive function test (inhibit interference)	After the intervention (3 months) and 12 months after baseline
Secondary	Neuroimage variables	Changes in white and grey matter. Measure will be performed with a MRI	After the intervention (3 months)