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

Hospital Clinic of Barcelona

Status: Unknown

Conditions: Psychotic Disorder

Treatments: Behavioral: Support therapy; Behavioral: Enhancing cognitive reserve

Study type: Interventional

Funder types: Other

Identifiers

NCT05288049

HCLinic

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 12 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Intervention aiming to enhance cognitive reserve (CR)

Experimental group

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.

Treatment:

Behavioral: Enhancing cognitive reserve

Support therapy

Active Comparator group

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.

Treatment:

Behavioral: Support therapy