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)

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• A statistical significant change in episodic memory functionning from Baseline 1 to Baseline 2 (Week 14). [Time frame: Baseline 1 (Week 0) and Baseline 2 (Week 14)]

Secondary outcome measures (9)

• A statistical significant change in working memory functionning from Baseline 1 to Baseline 2. [Time frame: Baseline 1 (Week 0) and Baseline 2 (Week 14)]
• A statistical significant change in mental flexibility from Baseline 1 to Baseline 2. [Time frame: Baseline 1 (Week 0) and Baseline 2 (Week 14)]
• A statistical significant change in mental flexibility from Baseline 1 to Baseline 2. [Time frame: Baseline 1 (Week 0) and Baseline 2 (Week 14)]
• A statistical significant change in inhibition ability from Baseline 1 to Baseline 2. [Time frame: Baseline 1 (Week 0) and Baseline 2 (Week 14)]
• A statistical significant change in sustained attention ability from Baseline 1 to Baseline 2. [Time frame: Baseline 1 (Week 0) and Baseline 2 (Week 14)]
• A statistical significant change in processing speed from Baseline 1 to Baseline 2. [Time frame: Baseline 1 (Week 0) and Baseline 2 (Week 14)]
• A statistical significant change in humor from Baseline 1 to Baseline 2. [Time frame: Baseline 1 (Week 0) and Baseline 2 (Week 14)]
• A statistical significant change in self-esteem from Baseline 1 to Baseline 2. [Time frame: Baseline 1 (Week 0) and Baseline 2 (Week 14)]
• A symptomatology statistical significant change from Baseline 1 to Baseline 2. [Time frame: Baseline 1 (Week 0) and Baseline 2 (Week 14)]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• CAEN University Hospital — Caen

Identifiers

NCT: NCT05880719 · 21-0179

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗