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Enhancing Cognitive Reserve of the Offsprings of Bipolar and Schizophrenic Patients

Primary Purpose

Bipolar and Related Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Enhancing Cognitive Reserve
Support intervention
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bipolar and Related Disorders focused on measuring bipolar disorder, schizophrenia, offsprings

Eligibility Criteria

6 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Enhancing cognitive reserve intervention

Supportive Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Bipolar Prodrome Symptom Interview and Scale_Prospective (BPSS_FP)
It is a specific interview for emerging bipolar disorder symptoms.
Continuous Performance Test
Sustained attention test
Wisconsin Card Sorting Test
Executive function test (set-shifting, flexibility)
Stroop Test
Executive function test (inhibit interference)
Neuroimage variables
Changes in white and grey matter. Measure will be performed with a MRI

Full Information

First Posted
October 11, 2018
Last Updated
May 4, 2022
Sponsor
Hospital Clinic of Barcelona
Collaborators
Institut d'Investigacions Biomèdiques August Pi i Sunyer, Consorcio Centro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT03722082
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Institut d'Investigacions Biomèdiques August Pi i Sunyer, Consorcio Centro de Investigación Biomédica en Red (CIBER), Instituto de Salud Carlos III

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar and Related Disorders
Keywords
bipolar disorder, schizophrenia, offsprings

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Primary outcome
Allocation
Randomized
Enrollment
173 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carla Torrent, Dr
Phone
932275400
Ext
4189
Email
ctorrent@clinic.ub.es
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena de la Serna, Dr
Phone
932275400
Ext
4212
Email
eserna@clinic.ub.es
First Name & Middle Initial & Last Name & Degree
Elena De la Serna, Dr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33631372
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. Rev Psiquiatr Salud Ment (Engl Ed). 2021 Feb 22:S1888-9891(21)00029-X. doi: 10.1016/j.rpsm.2021.02.003. Online ahead of print. English, Spanish.
Results Reference
derived

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Enhancing Cognitive Reserve of the Offsprings of Bipolar and Schizophrenic Patients

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