Self-administered COgnitive Personalized Training in Early Psychosis
SCOPe
2 other identifiers
interventional
240
1 country
1
Brief Summary
The overall objective of SCOPe is to improve early intervention in psychosis by providing an innovative eHealth tool that will enable personalized cognitive training, adapted to the individual's cognitive abilities. Cognitive remediation improves quality of life and functional outcome in patients with chronic psychosis. It would even be more efficacious in the early phase of psychosis by tackling the negative impact of psychosis on education achievement and employment. However, cognitive dysfunctions are often overlooked in FEP and cognitive remediation is not always accessible. New technologies can provide us with youth-friendly, non-stigmatizing tools, such as self administered, training applications so that all first-line clinical settings or professionals, and in fine all patients, can have access, wherever they live, to personalized cognitive training focusing on impaired functions. Early psychosis can be associated with inflammation, metabolic deficiency, as well as early structural brain anomalies that reflect brain plasticity abilities and could influence the prognosis and response to cognitive training. Our background hypothesis is that promoting neuroplasticity by cognitive training could attenuate or reverse early cognitive deficits and improve the overall functional outcome in young patients experiencing FEP and that this effect is modulated by individual brain plasticity abilities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 26, 2021
CompletedFirst Submitted
Initial submission to the registry
October 3, 2024
CompletedFirst Posted
Study publicly available on registry
October 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
October 10, 2024
September 1, 2024
5.2 years
October 3, 2024
October 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary assessment criterion
The main outcome will be the global functioning measured by the Personal and Social Performance (PSP) Scale after 3 months of cognitive training . The PSP is a 100-point single-item rating scale. The ratings are done by a clinician, in 5-10 min, and require minimal training, with excellent inter-rater reliability. The scale considers four main areas: 1. socially useful activities; 2. personal and social relationships; 3. self-care; and 4) disturbing and aggressive behaviours during a determined reference period (hereit will be the last month). It was found to be a quick and valid measure, sensitive to change, of patients; personal and social functioning even in early stage of psychosis.
Month 9
Study Arms (2)
Experimental group
EXPERIMENTALthe experimental group will use a mobile application for cognitive training for 3 months.
comparative control group
ACTIVE COMPARATORPatients in the control group will use video games with no prominent cognitive involvement
Interventions
Personalized cognitive training (PCT) HappyNeuronwill be delivered via a tablet or mobile application for 24 hours within 12 weeks, with a weekly supervision-call to reinforce their motivation. HappyNeuron Pro is a digital therapy tool designed for clinicians to provide engaging cognitive therapy via a web-based platform. It is compatible with PC, Mac, iPad, and Android devices and is available in multiple languages. The tool features exercises from established cognitive remediation programs. Functionality: The program offers 22 cognitive exercises targeting seven key functions outlined in the MATRICS framework: Processing Speed, Selective Attention, Reasoning and Working Memory, Verbal Memory, Visual Memory, and Auditory Memory. Exercises are customizable to meet individual patient needs, facilitating personalized cognitive training. User Experience: Each session comprises brief, self-administered exercises, with the order and difficulty adjusted by clinicians.
Patients in the control group will use video games with no prominent cognitive involvement no prominent cognitive involvement
Eligibility Criteria
You may qualify if:
- Adolescent and young adults, both genders, aged 16 to 35,
- Seeking help in one of the recruiting centers,
- Newly diagnosed as experiencing an Episode of Psychosis (reaching criteria as described in the Comprehensive Assessment of at Risk Mental States (CAARMS) within the year
- Written informed consent signed (and from one legal guardian for minors).
You may not qualify if:
- Severe and unstabilized medical conditions,
- Insufficient level in reading and/or French language,
- Absence of medical insurance,
- Participation in another intervention trial,
- Enforced hospitalization (ASPDT, ASPPI, ASPRE),
- Intellectuel Deficiency (IQ\<70), and / or sensorimotor deficits incompatible with the cognitive training,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groupe Hospitalier Universitaire Paris - Psychiatrie et Neurosciences, (GHU Paris)
Paris, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie Odile MO KREBS, PROFESSEUR
GHU PARIS Saint-Anne
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2024
First Posted
October 10, 2024
Study Start
October 26, 2021
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2027
Last Updated
October 10, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share