Enhancing Cognitive Reserve of the Offsprings of Bipolar and Schizophrenic Patients

NCT ID: NCT03722082

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2022-06-30

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.

Conditions

Bipolar and Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Enhancing cognitive reserve intervention

This intervention focuses in the improvement of academic skills, the increase of leisure activities and the improvement of neurocognitive functions with the ultimate goal of improving daily functioning. This intervention is based on ecological tasks that will be carried out in two areas, both in the hospital and at home. Most of the techniques are based on: pencil and paper tasks, with audiovisual and virtual reality support, telephone applications and group activities. The groups will be made with parents and children, adolescents and young adults separately being the content of the sessions the same but adapted to the age of the attendees.

Group Type: EXPERIMENTAL

Enhancing Cognitive Reserve

Intervention Type: BEHAVIORAL

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:

Supportive Intervention

The participants will not receive any structured intervention focused to enhance cognitive reserve. The therapists will adopt a client-centred focus, meaning that whatever problems the patient presents will be dealt with by providing emotional support and general advise.

Group Type: PLACEBO_COMPARATOR

Support intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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:

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut d'Investigacions Biomèdiques August Pi i Sunyer

OTHER

Sponsor Role: collaborator

Consorcio Centro de Investigación Biomédica en Red (CIBER)

OTHER_GOV

Sponsor Role: collaborator

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Carla Torrent

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Clinic

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Carla Torrent, Dr

Role: CONTACT

ctorrent@clinic.ub.es

932275400 ext. 4189

Facility Contacts

Elena de la Serna, Dr

Role: primary

eserna@clinic.ub.es

932275400 ext. 4212

References

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.

Reference Type: DERIVED

PMID: 33631372 (View on PubMed)

Other Identifiers

PI17/01066 and PI/1700741

Identifier Type: -

Identifier Source: org_study_id