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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)

Primary Purpose

Psychotic Episode

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Computer-assisted Music remediation
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychotic Episode focused on measuring Music, Computer Aided Music, Memory, First Psychotic Episode

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • CAEN University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Computer-assisted music remediation groupe

Arm Description

All participants benefit from 10 sessions of computer-assisted music remediation.These 10 sessions are spread over 3 month every Week.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 31, 2022
Last Updated
May 25, 2023
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT05880719
Brief Title
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)
Acronym
MAOPEP
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Episode
Keywords
Music, Computer Aided Music, Memory, First Psychotic Episode

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computer-assisted music remediation groupe
Arm Type
Experimental
Arm Description
All participants benefit from 10 sessions of computer-assisted music remediation.These 10 sessions are spread over 3 month every Week.
Intervention Type
Other
Intervention Name(s)
Computer-assisted Music remediation
Intervention Description
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.
Primary Outcome Measure Information:
Title
A statistical significant change in episodic memory functionning from Baseline 1 to Baseline 2 (Week 14).
Description
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.
Time Frame
Baseline 1 (Week 0) and Baseline 2 (Week 14)
Secondary Outcome Measure Information:
Title
A statistical significant change in working memory functionning from Baseline 1 to Baseline 2.
Description
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.
Time Frame
Baseline 1 (Week 0) and Baseline 2 (Week 14)
Title
A statistical significant change in mental flexibility from Baseline 1 to Baseline 2.
Description
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.
Time Frame
Baseline 1 (Week 0) and Baseline 2 (Week 14)
Title
A statistical significant change in mental flexibility from Baseline 1 to Baseline 2.
Description
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.
Time Frame
Baseline 1 (Week 0) and Baseline 2 (Week 14)
Title
A statistical significant change in inhibition ability from Baseline 1 to Baseline 2.
Description
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.
Time Frame
Baseline 1 (Week 0) and Baseline 2 (Week 14)
Title
A statistical significant change in sustained attention ability from Baseline 1 to Baseline 2.
Description
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.
Time Frame
Baseline 1 (Week 0) and Baseline 2 (Week 14)
Title
A statistical significant change in processing speed from Baseline 1 to Baseline 2.
Description
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.
Time Frame
Baseline 1 (Week 0) and Baseline 2 (Week 14)
Title
A statistical significant change in humor from Baseline 1 to Baseline 2.
Description
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.
Time Frame
Baseline 1 (Week 0) and Baseline 2 (Week 14)
Title
A statistical significant change in self-esteem from Baseline 1 to Baseline 2.
Description
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.
Time Frame
Baseline 1 (Week 0) and Baseline 2 (Week 14)
Title
A symptomatology statistical significant change from Baseline 1 to Baseline 2.
Description
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.
Time Frame
Baseline 1 (Week 0) and Baseline 2 (Week 14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MEKIDICHE-VARGAS Leïla, Diploma in Practical Nursing
Phone
0761883207
Email
vargas-l@chu-caen.fr
Facility Information:
Facility Name
CAEN University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

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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)

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