Clinical trial NCT03722082: Enhancing Cognitive Reserve of the Offsprings of Bipolar and Schizophrenic Patients
Official title: Study About the Effectiveness of Enhancing Cognitive Reserve in Children, Adolescents and Young Adults at Genetic Risk for Psychosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar and Related Disorders
Keywords: bipolar disorder
schizophrenia
offsprings
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Institut d'Investigacions Biomèdiques August Pi i Sunyer
name: Consorcio Centro de Investigación Biomédica en Red (CIBER)
name: Instituto de Salud Carlos III
First posted: 2018-10-26
Enrollment: 173
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cognitive reserve
timeFrame: 3 months afther the intervention and 12 months after baseline
Secondary outcomes:
measure: Hamilton Depression Rating Scale (HDRS-21)
timeFrame: After the intervention (3 months) and 1 year after baseline
measure: Young Mania Rating Scale (YMRS)
timeFrame: After the intervention (3 months) and 1 year after baseline
measure: Bipolar Prodrome Symptom Interview and Scale_Prospective (BPSS_FP)
timeFrame: 12 months after baseline
measure: Continuous Performance Test
timeFrame: After the intervention (3 months) and 12 months after baseline
measure: Wisconsin Card Sorting Test
timeFrame: After the intervention (3 months) and 12 months after baseline
measure: Stroop Test
timeFrame: After the intervention (3 months) and 12 months after baseline
measure: Neuroimage variables
timeFrame: After the intervention (3 months)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References:
citation: de la Serna E, Montejo L, Sole B, Castro-Fornieles J, Camprodon-Boadas P, Sugranyes G, Rosa-Justicia M, Martinez-Aran A, Vieta E, Vicent-Gil M, Serra-Blasco M, Cardoner N, Torrent C. Effectiveness of enhancing cognitive reserve in children, adolescents and young adults at genetic risk for psychosis: Study protocol for a randomized controlled trial. Span J Psychiatry Ment Health. 2023 Jul-Sep;16(3):184-191. doi: 10.1016/j.rpsm.2021.02.003. Epub 2021 Feb 22.