Self-administered COgnitive Personalized Training in Early Psychosis (SCOPe)

October 8, 2024 updated by: Centre Hospitalier St Anne

Self-administered COgnitive Personalized Training in Early Psychosis: a Randomized Controlled Trial in Adolescents and Young Adults to Assess Efficacy and Efficiency of an EHealth Application Providing Personalized Cognitive Training

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France
        • Recruiting
        • Groupe Hospitalier Universitaire Paris - Psychiatrie et Neurosciences, (GHU Paris)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
the experimental group will use a mobile application for cognitive training for 3 months.
Device: a mobile application for cognitive training

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.

Other Names:
  • cognitive training
  • HappyNeuron Pro
  • Personalized cognitive training
Active Comparator: comparative control group
Patients in the control group will use video games with no prominent cognitive involvement
Device: video games
Patients in the control group will use video games with no prominent cognitive involvement no prominent cognitive involvement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary assessment criterion
Time Frame: Month 9

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier St Anne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie Odile MO KREBS, PROFESSEUR, GHU PARIS Saint-Anne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D19-P002
  • 2019 A00399 48 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings