NCT05288049

Treating Early Stages With an Intervention Targeting Cognitive Reserve

Treating Early Stages Of seveRe Mental disOrders With an Intervention Targeting Cognitive Reserve

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 12 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Psychotic Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Enhancing cognitive reserve	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.
BEHAVIORAL	Support therapy	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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2022-03-18
• Last updated: 2022-03-18

Locations

1 site across 1 country: Spain