Clinical trial NCT05288049: Treating Early Stages With an Intervention Targeting Cognitive Reserve
Official title: Treating Early Stages Of seveRe Mental disOrders With an Intervention Targeting Cognitive Reserve
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychotic Disorder
Keywords: cognitive reserve
psychotic disorder
offsprings
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 180
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: cognitive reserve
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References: