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) (MAOPEP)

Pilot and Descriptive Study of the Effects of the Implementation of Computer Assisted Music Remediation Groups on the Cognitive Functioning of Young Patients Presenting a First Episode Psychosis

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.

Study Overview

• Status: Recruiting
• Conditions: Psychotic Episode
• Intervention / Treatment: Other: Computer-assisted Music remediation

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MEKIDICHE-VARGAS Leïla, Diploma in Practical Nursing; Phone Number: 0761883207; Email: vargas-l@chu-caen.fr

Study Locations

• France
  • Caen, France, 14033
    • Recruiting
    • CAEN University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computer-assisted music remediation groupe; All participants benefit from 10 sessions of computer-assisted music remediation.These 10 sessions are spread over 3 month every Week.	Other: Computer-assisted Music remediation; These sessions of computer-assisted music remediation last 1h and are each divide in 4 parts : 15 minutes of music improvisation; 20 minutes of harmony and rythm exercices; 20 minutes of Lesson about the software and musical interfaces; 5 minutes of debrief.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A statistical significant change in episodic memory functionning from Baseline 1 to Baseline 2 (Week 14).	An assessment of the episodic verbal memory will be performed at Baseline 1 (Week 0) and at Baseline 2 (Week 14) with the WMS-IV (Weschler Memory Scale 4th edition). This scale provides an episodic memory measure varying from 60 to 140 (mean = 100 ; standard deviation = 15). This measure is called Delayed Memory Index.	Baseline 1 (Week 0) and Baseline 2 (Week 14)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A statistical significant change in working memory functionning from Baseline 1 to Baseline 2.	An assessment of the episodic verbal memory will be performed at Baseline 1 and at Baseline 2 with the WMS-IV (Wechsler Memory Scale 4th edition). This scale provides a working memory measure varying from 60 to 140 (mean = 100; standard deviation = 15). This measure is called Immediate Memory Index.	Baseline 1 (Week 0) and Baseline 2 (Week 14)
A statistical significant change in mental flexibility from Baseline 1 to Baseline 2.	An assessment of the mental flexibility will be performed at Baseline 1 and at Baseline 2 with de Modified Card Sorting Test. This test provides a mental flexibility measure using the errors numbers at the task.	Baseline 1 (Week 0) and Baseline 2 (Week 14)
A statistical significant change in mental flexibility from Baseline 1 to Baseline 2.	An assessment of the mental flexibility will be performed at Baseline 1 and at Baseline 2 with the verbal fluency test. This test provides a mental flexibility measure using the number of words given through 2 minutes.	Baseline 1 (Week 0) and Baseline 2 (Week 14)
A statistical significant change in inhibition ability from Baseline 1 to Baseline 2.	An assessement of the inhibition ability will be performed at Baseline 1 and Baseline 2 with the Stroop test. This test provides an inhibition measure using the errors numbers at this task.	Baseline 1 (Week 0) and Baseline 2 (Week 14)
A statistical significant change in sustained attention ability from Baseline 1 to Baseline 2.	An assessment of the sustained attention will be performed at Baseline 1 and Baseline 2 with the PASAT (Paced Auditory Serial Addition Test ). This test provides an sustained attention measure using an overall score.	Baseline 1 (Week 0) and Baseline 2 (Week 14)
A statistical significant change in processing speed from Baseline 1 to Baseline 2.	An assessment of the processing speed will be performed at Baseline 1 and Baseline 2 with the symbols subtest of the WAIS-IV (Wechsler Adult Intelligence Scale 4th edition). This test provides a processing speed measure using an overall score.	Baseline 1 (Week 0) and Baseline 2 (Week 14)
A statistical significant change in humor from Baseline 1 to Baseline 2.	An assessment of the humor will be performed at Baseline 1 and Baseline 2 with the Calgary scale. This scale provides an humor overall score varying from 0 to 27. Above the treshold score of 6 there is a major depressive episode.	Baseline 1 (Week 0) and Baseline 2 (Week 14)
A statistical significant change in self-esteem from Baseline 1 to Baseline 2.	An assessment of the self-esteem will be performed at Baseline 1 and Baseline 2 with the SERS (Self-Esteem Rating Scale). This scale gives a self-esteem measure using two overall score from -70 to -10 and from 10 to 70 according to the scales.	Baseline 1 (Week 0) and Baseline 2 (Week 14)
A symptomatology statistical significant change from Baseline 1 to Baseline 2.	An assessment of the symptomatology will be performed at Baseline 1 and Baseline 2 with the PANSS (Positive And Negative Syndrom Scale). This scale provides an overall score varying from 40 to 280. A higher score means importants symptômes.	Baseline 1 (Week 0) and Baseline 2 (Week 14)

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Memory; Music; Computer Aided Music; First Psychotic Episode
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 21-0179

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No