Schizophrenia DisordersARCoS-2NCT07055204
Cognitive Remediation Method Using Rhythmic, Vocal and Corporal Musical Learning for Schizophrenia
A study testing "Diapason & Metronome" musical learning in people with Schizophrenia Disorders, run by University Hospital, Toulouse at 6 sites in France.
Trial summary
Schizophrenia, affecting 1% of the population, is a persistent disorder characterized by varied symptoms. Antipsychotic medications effectively address positive symptoms (delusions, hallucinations) and relapse but have limited impact on negative symptoms (e.g., blunted affect, anhedonia) and cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia Disorders
- What is being tested?
- "Diapason & Metronome" musical learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 6 sitesFrance
- Study dates
- 21 Oct 2026to 31 Dec 2028
- Phase
- Interventional
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient with a diagnosis of schizophrenia or schizoaffective disorder (DSM-5 TR criteria)
- Clinically stable (no full-time hospitalization related to schizophrenia for 3 months)
- Regular psychiatric follow-up
- Enrolled in at least 1 therapeutic or social out-of-home activity
- No change in the antipsychotic treatment for 3 months (medication and/or dosage)
- Have given free, informed and written consent to participate in the study.
- Patient affiliated or beneficiary of a social security scheme
Who cannot join
- Patient with moderate to severe intellectual disability (clinical criteria)
- Engaged in a Social rythmic or musical activity
- Presenting an addictive comorbidity (excluding tobacco addiction and behavioural addictions)
- Presenting a neurological pathology with cognitive impact
- Involved in a neurocognitive remediation program
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tudi Gozé, MD contact
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
CH de la Côte Basque
Bayonne
Dr Sophie Athéna Chapron, MD, +33 (0)5 61 43 78 63, sachapron@ch-cotebasque.fr
- Recruiting
CH Le Vinatier
Bron
Pr Frédéric Haesebaert, MD PHD, +33 (0)5 61 43 78 63, frederic.haesebaert@ch-le-vinatier.fr
- Not yet recruiting
Assistance Publique Hôpitaux de Marseille
Marseille
Pr Michel Cermolacce, MD PHD, +33 (0)5 61 43 78 63, michel.cermolacce@ap-hm.fr
- Recruiting
Association route nouvelle
Toulouse
Dr Rafaele Combaud, MD, +33 (0)5 61 43 78 63, rafaele.combaud@routenouvelle.fr
- Recruiting
Centre de Santé MGEN
Toulouse
Dr Florent Amadei, MD, +33 (0)5 61 43 78 63, FAMADEI@mgen.fr
- Recruiting
CH Gérard Marchant
Toulouse
Emmanuel Gallet, MD, +33 (0)5 61 43 78 63, emmanuel.gallet@ch-marchant.fr
About this study
Official title: Multicenter Study Evaluating the Efficacy of a Cognitive Remediation Method Using Rhythmic, Vocal and Corporal Musical Learning for Schizophrenia Patients
Schizophrenia, affecting 1% of the population, is a persistent disorder characterized by varied symptoms. Antipsychotic medications effectively address positive symptoms (delusions, hallucinations) and relapse but have limited impact on negative symptoms (e.g., blunted affect, anhedonia) and cognitive impairment. These dimensions significantly influence social functioning and quality of life. Combining non-pharmacological approaches like Cognitive Remediation (CR) and psychosocial rehabilitation alongside antipsychotic drugs is recommended to enhance overall functioning and quality of life. Current CR programs show moderate effectiveness due to patient commitment issues. However, completed programs demonstrate higher efficacy. Real-life applicability of these programs lacks sufficient data. We propose musical learning for cognitive remediation due to its established cognitive benefits in the general population, targeting executive functions, working memory, attention, and inhibition. These functions are specifically impaired in schizophrenia and thus are relevant for remediation. Though unexplored in schizophrenia, music learning seems promising due to its motivational and pleasurable aspects for long-term commitment and its transferability through embodied and situated dimensions. A pilot study (ARCoS-1) on CR by musical learning demonstrated feasibility and preliminary positive results on cognitive and negative symptoms. This project aims to assess this method's effectiveness on a larger scale. Our hypothesis posits that musical learning offers an efficient and well-received medium for CR in patients with schizophrenia.
Read the detailed description
This study will be a national, multicenter, randomized, open label, comparative study evaluating the impact of 6-month collective embodied musical learning program on attentional deficits, in comparison with a control group receiving standard care.
Patients will be randomized in each center in 2 groups: one group will participate in weekly musical learning sessions, the other one will beneficit of standard care.
The study will be conducted in 2 phases:
- Phase 1 (six months of collective rhythmic, vocal and corporal musical training): 6 groups of 10 patients will participate in 6-month collective musical training provided by a professional music teacher. Sessions will start no later than 3 months after the inclusion, at the rate of one session per week for a period of 6 months (24 sessions in all, as part of a pedagogical project). Each session lasts one hour.
- Phase 2: a post-remediation follow-up period of 3 months (after the musical training sessions have stopped) to evaluate the potential lasting effect of group musical training on cognitive disorders and negative symptoms in patients.
For each patient, the duration of the protocol is 9 months, with assessment visits scheduled at regular 3-month intervals (Inclusion, M3, M6 and M9) for a total of 4 visits. Before the inclusions begin, 6 music teachers will be trained in the musical learning method developed for this project (one teacher in each participating town : Bayonne, Lyon, Marseille, Paris, Toulouse).
- Conditions
- Schizophrenia Disorders
- Being tested
- "Diapason & Metronome" musical learning
- Keywords
- cognitive remediation, music, rythmic, vocal, corporal, musical learning
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Diapason & Metronome" musical learningOther
Participants will make music with the two instruments we all have in common: the voice and the body. The method is three-dimensional built on: rhythm, simple sound and harmony. The music sessions will take place in the same place and on the same day of the week, at a fixed time to establish a regularity that is suitable to this population. The courses will be taught in a cultural location, both to give meaning to the approach on a contextual level and to allow patients to be in the city and not in the hospital. A training of the music teachers will be planned before the beginning of the study. This training combined with regular debriefings during the music sessions, should ensure that the teachers' practices are consistent across the different groups.
| Study group | Role | What they receive |
|---|---|---|
| "Diapason & Metronome" musical learning arm | Experimental | The "Diapason \& Metronome" musical learning method was developed specifically by the authors of the study. Participants will make music with the two instruments we all have in common: the voice and the body. Receives: Other: "Diapason & Metronome" musical learning |
| standard of care arm | No intervention | Patients randomly assigned in the control group will receive standard regular outpatient psychiatric care with at least one therapeutic or social activity (except musical or rhythmic activities). The "standard of care" is defined by regular psychiatric follow-up by a doctor specialised in psychiatry, and the use of antipsychotic medication. Care may be provided by a private psychiatrist, a Centre Médico-Psychologique (CMP) or a psychiatric day hospital. The frequency of treatment can vary from weekly to monthly, depending on the patient's state of stability. In addition, patients must be enrolled in at least one social or therapeutic activity during the week (therapeutic workshop in a day hospital or CATTP (Centre Accueil Thérapeutique à Temps Partiel), workshop in a GEM (Groupe d'Entraide Mutuelle), voluntary activity, club sport, or professional activity). |
What is being measured
The primary outcome is the main question the study is designed to answer.
attention capacity
The primary endpoint will be to compare treated and control groups on the change from baseline to M6 (evaluation at the end of the remediation phase) of the D2-R scale score.
D2-R scale (Brickenkamp, R. et al, 2015) is a paper-and-pencil test that provides a fine-tuned measure of selective and sustained attention.
The test requires the subject to identify and cross out target characters (d with 2 dashes) from a large number of distractor characters. It therefore requires concentrated and sustained visual attention, and mobilises inhibitory control. There are three indicators of the strategy employed and the evolution of concentration:
- CC - concentration capacity or concentration performance
- CCT - work rhythm or processing speed
- E% - processing precision --> the higher the score for each category, the better the attention capacity is
Measured: Baseline = Day 0 ; Month 6
Secondary outcomes (2)
Attentional deficits at 3 months after the start of the remediation (M3) and at 3 months post-remediation (M9)
Change from baseline to M3 and M9 (evaluation at 3 month of the remediation phase) of the D2-R scale score
D2-R scale (Brickenkamp, R. et al, 2015) is a paper-and-pencil test that provides a fine-tuned measure of selective and sustained attention.
The test requires the subject to identify and cross out target characters (d with 2 dashes) from a large number of distractor characters. It therefore requires concentrated and sustained visual attention, and mobilises inhibitory control. There are three indicators of the strategy employed and the evolution of concentration:
- CC - concentration capacity or concentration performance
- CCT - work rhythm or processing speed
- E% - processing precision --> the higher the score for each category, the better the attention capacity is
Measured: Baseline = Day 0 ; Month 6 and Month 9 (evaluation at 3 month of the remediation phase)
Attentional phasic alert at 3 months after the start of remediation (M3), at the end of the remediation phase (M6) and at 3 months post-remediation (M9).
Change in attention abilities evaluated by the results obtained in the phasic alert test of the TAP, from baseline to M3, M6 and M9.
TAP = Test of Attentional Performance is a computer-based battery for assessing attention. The phasic alert test : refers to a state of general arousal that allows for quick and appropriate responses to stimuli. It is an indispensable condition for effective behavior and constitutes, from this point of view, a basis for all attentional performances. Reaction times (RT) are examined under two conditions. The first concerns the evaluation of simple RT: a cross appears in the center of the screen after randomly varying inter-stimulus intervals, and the subject must react as quickly as possible by pressing a response key. In this condition, intrinsic alertness is measured. In the second condition, RTs are measured as responses to the same cross but this time preceded by a (auditory) stimulus.
--> The lowest the RT, the better is the attention ability
Measured: Baseline = Day 0 ; Month 6 and Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start21 Oct 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- national, multicenter, randomized, open label, comparative study
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055204
- Sponsor's protocol ID
- RC31/24/0332
- Acronym
- ARCoS-2
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No