NCT05880719 Pilot and Descriptive Study of the Effects of Setting up Computer-assisted Music (CAM) Remediation Groups on the Cognitive Functioning of Young Patients With a First Episode Psychosis (PEP)
| NCT ID | NCT05880719 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Caen |
| Condition | Psychotic Episode |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-05-25 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-05-25 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The use of music in the field of cognitive remediation is growing and much research has focused on the relevance and effectiveness of its use in care. Studies have therefore made it possible to show the relevance of the use of musical material in the remediation of patients with various pathologies with cognitive disorders (head trauma, stroke, Alzheimer's disease). Although cognitive remediation has been widely studied in patients with schizophrenia, few studies suggest the effects of remediation in patients with a first psychotic episode. No study currently demonstrates the relevance of this material in the remediation of young people presenting a first psychotic episode. The Mobile Intensive Care Team of the Adult Psychiatry Service of the CHU de Caen (EMSI) takes care of patients who have presented with a first psychotic episode. Young people entering an emerging psychosis frequently exhibit cognitive impairment. These attacks are variable and can concern memory, attentional and executive functioning. The most frequent disorders concern memory functioning and it is important to deal with them early in order to improve the functional prognosis of the young person. We therefore propose the establishment of cognitive remediation groups through the MAO with patients treated by EMSI. These groups would aim to heal memory, attention and executive functions through exercises and musical practice through the Ableton © software. We therefore propose a study that would assess the effects of these workshops on the cognitive functioning of patients with memory difficulties. Attentional and executive functioning as well as self-esteem and negative symptoms will also be assessed. This remedy will be offered in groups of 4. In this feasibility study, 30 patients will be included depending on the inclusion and monitoring capacities of the center. Ten weekly sessions of one hour per group over a period of 3 months will be applied. To assess the beneficial effects of this group remediation, assessments will be carried out at the start of the study and at the end of the 10 sessions. The aim of this study is to assess the effects of an CAM remediation group on cognitive functioning, mood and self-esteem in patients who presented with a first psychotic episode.
Eligibility Criteria
Inclusion Criteria: * Patient aged 18 to 30 years. * Consult for a first psychotic episode according to the criteria of the DSM-V * Francophone patient * With at least one memory deficit highlighted at the neuropsychological assessment of entry into the EMSI * Benefiting from a follow-up within the EMSI * Affiliated to the social security system * Clinically stabilized patient one month away from psychiatric hospitalization * Patient who has been informed of the study and has given his informed consent. Exclusion Criteria: Inability to give the patient informed information * Not meeting the criteria of the DSM-V of first episode of psychosis * Absence of memory cognitive disorders at the neuropsychological assessment of entry into the EMSI department. * Patient who has already had cognitive remediation in his EMSI management. * Patients under judicial protection measure (guardianship or curatorship).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05880719 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 30 Years, studying Psychotic Episode. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05880719 currently recruiting?
Yes, NCT05880719 is actively recruiting participants. Contact the research team at vargas-l@chu-caen.fr for enrollment information.
Where is the NCT05880719 trial being conducted?
This trial is being conducted at Caen, France.
Who is sponsoring the NCT05880719 clinical trial?
NCT05880719 is sponsored by University Hospital, Caen. The trial plans to enroll 30 participants.