Psychotic EpisodeMAOPEPNCT05880719
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)
A study testing Computer-assisted Music remediation in people with Psychotic Episode, run by University Hospital, Caen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Psychotic Episode
- What is being tested?
- Computer-assisted Music remediation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2023to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
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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
- Being tested
- Computer-assisted Music remediation
- Keywords
- Music, Computer Aided Music, Memory, First Psychotic Episode
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-assisted Music remediationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Computer-assisted Music remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline 1 (Week 0) and Baseline 2 (Week 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start25 May 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic EpisodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880719
- Sponsor's protocol ID
- 21-0179
- Acronym
- MAOPEP
- Status last verified
- Jun 2026
- First submitted
- 31 May 2022
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05880719
- Acronym / sponsor ID
- MAOPEP / 21-0179
- Conditions
- Psychotic Episode
- Keywords
- Music, Computer Aided Music, Memory, First Psychotic Episode
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computer-assisted music remediation groupe | Experimental | Other: Computer-assisted Music remediationAll participants benefit from 10 sessions of computer-assisted music remediation.These 10 sessions are spread over 3 month every Week. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-assisted Music remediationThese 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. | Other | Computer-assisted music remediation groupe |
Primary outcome
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)
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.
9 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-assisted Music remediation in people with Psychotic Episode, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MEKIDICHE-VARGAS Leïla, Diploma in Practical Nursing (0761883207, vargas-l@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.