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Treating Early Stages With an Intervention Targeting Cognitive Reserve (TESORO)

Primary Purpose

Psychotic Disorder

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

About this trial

This is an interventional prevention trial for Psychotic Disorder focused on measuring cognitive reserve, psychotic disorder, offsprings

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. - Inclusion criteria for the Off-SZBP will be: Subjects between 12 and 25 years with a parent (mother or father) diagnosed with bipolar disorder or schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria.

  2. - Inclusion criteria for patients with a first affective (mania or depression with or without psychotic symptoms and hypomania) or non-affective episode (first psychotic episode) will be:

    1. Patients between 12 and 45 years with a first affective or non-affective episode within the last 5 years.
    2. Diagnosis of bipolar disorder, schizophrenia, schizoaffective disorders and other psychoses according to DSM-5 criteria based on a semi-structured clinical interview.
    3. Patients in full or partial clinical remission at the moment of assessment, defined as scores ≤ 10 in Young Mania Rating Scale (YMRS) (Young, 1978) and ≤ 14 scores in the Hamilton Depression Rating Scale (Hamilton, 1960).
    4. Scores lower or equal to 3 during the previous two months in symptoms P1 (delusions), G9 (unusual thought content), P3 (hallucinations), P2 (conceptual disorganization), G5 (mannerisms and posturing), N1 (blunted affect), N4 (social withdrawal) and N6 (spontaneity and flow of conversation) on the scale for positive and negative schizophrenia syndrome (PANSS).

  3. - Inclusion criteria for Community Control:s (CC) Children, adolescents and young adults between 12 and 45 years old without history of psychotic disorder or bipolar disorder in first degree relatives.

    • Exclusion criteria, common to all participants, will be:

      1. Estimated Intelligence quotient < 70.
      2. Any medical condition that could affect neuropsychological performance (such as neurological diseases) or history of head trauma with loss of consciousness.
      3. To have participated in any structured psychosocial intervention within the past 6 months.

Sites / Locations

  • Hospital ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention aiming to enhance cognitive reserve (CR)

Support therapy

Arm Description

The psychological intervention to enhance cognitive reserve (CR) will be conducted in a group format (6-8 individuals). Each session will last approximately 60 minutes. The full psychological intervention will have 12 sessions (1 per week) and will last three months. Moreover, to remind the participants of the contents of the intervention, a follow-up session will be held every two months between the last session of the psychological intervention and the 12-month assessment. Most of the tasks of the psychological intervention will use pen and paper with audiovisual support. However, some sessions will use mobile apps and virtual reality. Virtual reality will be implemented for each patient in the sessions focusing on mindfulness training. The contents of the sessions are adapted to the different ages of the attendees. Groups with adolescents and those with young adults will be run separately.

The support control group will have weekly meetings with assistants to talk about the difficulties they had during the week, without receiving a specific intervention. After the 12-month assessment, subjects in the support group will be offered the intervention although this will be out of the scope of this study.

Outcomes

Primary Outcome Measures

cognitive reserve
the enhancing of cognitive reserve by means of the Cognitive Reserve Assessment Scale (CRASH scale). The CRASh scale is an interviewer-administered instrument which consists of 23 items to assess three domains related with the cognitive reserve: education, occupation and leisure and intellectual activities. This last domain will have evaluated taking into account the different life stages (childhood/adolescence, adulthood and current situation). The scale provides a total score and different scores for each specific domain. The maximum total score is 60 points. Each domain scores is calculated by adding all items of the domain. The higher scores, the higher CR level.

Secondary Outcome Measures

Full Information

First Posted
December 8, 2021
Last Updated
March 15, 2022
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT05288049
Brief Title
Treating Early Stages With an Intervention Targeting Cognitive Reserve
Acronym
TESORO
Official Title
Treating Early Stages Of seveRe Mental disOrders With an Intervention Targeting Cognitive Reserve
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study proposes continuity in the implementation of a psychological approach program to enhance cognitive reserve (CR) in children, adolescent and young adults, off-springs of patients with schizophrenia or bipolar disorder (Off-SZBP), and first affective and non-affective episodes with three main objectives: to characterize the cognitive reserve in the early stages of the disease, to validate the adaptation of the intervention to first affective and non-affective disorders to assess the effectiveness of the intervention in a longer term.
Detailed Description
The study will include a sample of High Genetic Risk-SZBD (HR-SZBD) subjects (N = 60), First Episode Psychotic Patients (FEP) (N = 60) and CC participants (N = 60). All groups will be evaluated with CR scales as well as clinical, neuropsychological, and neuroimaging tests at baseline. The FEP and HR-SZBD groups will then be randomly allocated to a psychological intervention to enhance CR (N = 30 FEP and 30 HR-SZBD) or a support group (N = 30 FEP and 30 HR-SZBD). Once the psychological intervention (3 months) is completed, the FEP and HR-SZBD groups will be re-assessed with the same clinical, neuropsychological, and neuroimaging tests as well as CR scales that were used at baseline. Between the third and twelfth month, follow-up sessions will be conducted to remind the participants of the contents of the intervention. Finally, clinical, CR, neuropsychological and neuroimaging assessments will be completed in the FEP, HR-SZBD and CC groups at 12 months to verify whether the effects of the intervention remain stable over time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorder
Keywords
cognitive reserve, psychotic disorder, offsprings

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
An experimental randomized controlled clinical study is proposed, which will be rater-blinded and stratified by age, gender and socioeconomic status to assess the efficacy of a new intervention designed to increase CR in FEP and HR-SZBD subjects.
Masking
Investigator
Masking Description
The experimental group will receive 12 weekly sessions (1 per week) of the intervention, which will be conducted by two psychologists blinded to the assessments.
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention aiming to enhance cognitive reserve (CR)
Arm Type
Experimental
Arm Description
The psychological intervention to enhance cognitive reserve (CR) will be conducted in a group format (6-8 individuals). Each session will last approximately 60 minutes. The full psychological intervention will have 12 sessions (1 per week) and will last three months. Moreover, to remind the participants of the contents of the intervention, a follow-up session will be held every two months between the last session of the psychological intervention and the 12-month assessment. Most of the tasks of the psychological intervention will use pen and paper with audiovisual support. However, some sessions will use mobile apps and virtual reality. Virtual reality will be implemented for each patient in the sessions focusing on mindfulness training. The contents of the sessions are adapted to the different ages of the attendees. Groups with adolescents and those with young adults will be run separately.
Arm Title
Support therapy
Arm Type
Active Comparator
Arm Description
The support control group will have weekly meetings with assistants to talk about the difficulties they had during the week, without receiving a specific intervention. After the 12-month assessment, subjects in the support group will be offered the intervention although this will be out of the scope of this study.
Intervention Type
Behavioral
Intervention Name(s)
Enhancing cognitive reserve
Intervention Description
The CR enhancement protocol consists of 12 weekly sessions in a group format with audiovisual and technological devices support. All sessions are held separately for parents and children, adolescents and young adults. All material is adapted to different ranges of age. This same protocol will be adapted for patients with a first affective or non-affective episode. Two sessions are about to promote healthy lifestyle by implementing healthy habits, two more sessions about training and practice mindfulness with virtual reality devices, two sessions about improving leisure-time activities, focused on promoting of intellectual and/or cultural activities as leisure time as well as physical exercise, the rest of sessions are about to promote vocational and educational activities, metacognition, social skills, problem-solving techniques and how to detect and act on warning signs, a brief psychoeducative session about the main early warning signs of general psychopathology.
Intervention Type
Behavioral
Intervention Name(s)
Support therapy
Intervention Description
The support control group will have weekly meetings with assistants to talk about the difficulties they had during the week, without receiving a specific intervention.
Primary Outcome Measure Information:
Title
cognitive reserve
Description
the enhancing of cognitive reserve by means of the Cognitive Reserve Assessment Scale (CRASH scale). The CRASh scale is an interviewer-administered instrument which consists of 23 items to assess three domains related with the cognitive reserve: education, occupation and leisure and intellectual activities. This last domain will have evaluated taking into account the different life stages (childhood/adolescence, adulthood and current situation). The scale provides a total score and different scores for each specific domain. The maximum total score is 60 points. Each domain scores is calculated by adding all items of the domain. The higher scores, the higher CR level.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Inclusion criteria for the Off-SZBP will be: Subjects between 12 and 25 years with a parent (mother or father) diagnosed with bipolar disorder or schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria. - Inclusion criteria for patients with a first affective (mania or depression with or without psychotic symptoms and hypomania) or non-affective episode (first psychotic episode) will be: Patients between 12 and 45 years with a first affective or non-affective episode within the last 5 years. Diagnosis of bipolar disorder, schizophrenia, schizoaffective disorders and other psychoses according to DSM-5 criteria based on a semi-structured clinical interview. Patients in full or partial clinical remission at the moment of assessment, defined as scores ≤ 10 in Young Mania Rating Scale (YMRS) (Young, 1978) and ≤ 14 scores in the Hamilton Depression Rating Scale (Hamilton, 1960). Scores lower or equal to 3 during the previous two months in symptoms P1 (delusions), G9 (unusual thought content), P3 (hallucinations), P2 (conceptual disorganization), G5 (mannerisms and posturing), N1 (blunted affect), N4 (social withdrawal) and N6 (spontaneity and flow of conversation) on the scale for positive and negative schizophrenia syndrome (PANSS). - Inclusion criteria for Community Control:s (CC) Children, adolescents and young adults between 12 and 45 years old without history of psychotic disorder or bipolar disorder in first degree relatives. Exclusion criteria, common to all participants, will be: Estimated Intelligence quotient < 70. Any medical condition that could affect neuropsychological performance (such as neurological diseases) or history of head trauma with loss of consciousness. To have participated in any structured psychosocial intervention within the past 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carla Torrent, PhD
Phone
+34932275400
Ext
4189
Email
ctorrent@clinic.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Elena de la Serna, PhD
Phone
+34932275400
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Torrent, PhD
Email
ctorrent@clinic.cat
First Name & Middle Initial & Last Name & Degree
Elena de la Serna, PhD
First Name & Middle Initial & Last Name & Degree
Eduard Vieta, MD
First Name & Middle Initial & Last Name & Degree
Josefina Castro-Fornieles, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Treating Early Stages With an Intervention Targeting Cognitive Reserve

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