Treating Early Stages With an Intervention Targeting Cognitive Reserve

NCT05288049 | Unknown DMC

• 1 other identifier: HCLinic
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorder

Keywords

cognitive reserve; psychotic disorder; offsprings

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (2)

Intervention aiming to enhance cognitive reserve (CR)

EXPERIMENTAL

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.

Behavioral: Enhancing cognitive reserve

Support therapy

ACTIVE COMPARATOR

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.

Behavioral: Support therapy

Interventions

Enhancing cognitive reserve BEHAVIORAL

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 aiming to enhance cognitive reserve (CR)

Support therapy BEHAVIORAL

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.

Support therapy

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Carla Torrent, PhD

CONTACT

+34932275400; ctorrent@clinic.cat

Elena de la Serna, PhD

CONTACT

+34932275400

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: March 18, 2022
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: March 18, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)