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)

NCT05880719 | Unknown DMC

• 1 other identifier: 21-0179
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Episode

Keywords

Music; Computer Aided Music; Memory; First Psychotic Episode

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• A statistical significant change in working memory functionning from Baseline 1 to Baseline 2.

  Baseline 1 (Week 0) and Baseline 2 (Week 14)

• A statistical significant change in mental flexibility from Baseline 1 to Baseline 2.

  Baseline 1 (Week 0) and Baseline 2 (Week 14)

• A statistical significant change in mental flexibility from Baseline 1 to Baseline 2.

  Baseline 1 (Week 0) and Baseline 2 (Week 14)

• A statistical significant change in inhibition ability from Baseline 1 to Baseline 2.

  Baseline 1 (Week 0) and Baseline 2 (Week 14)

• A statistical significant change in sustained attention ability from Baseline 1 to Baseline 2.

  Baseline 1 (Week 0) and Baseline 2 (Week 14)

Study Arms (1)

Computer-assisted music remediation groupe

EXPERIMENTAL

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

Interventions

Computer-assisted Music remediation OTHER

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.

Computer-assisted music remediation groupe

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CAEN University Hospital

Caen, 14033, France

RECRUITING

Central Study Contacts

MEKIDICHE-VARGAS Leïla, Diploma in Practical Nursing

CONTACT

0761883207; vargas-l@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: May 30, 2023
• Study Start: May 25, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 30, 2023

Record last verified: 2023-05

Locations

FR (1)