Multicenter Study Evaluating the Efficacy of a Cognitive Remediation Method Using Rhythmic, Vocal and Corporal Musical Learning for Schizophrenia Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- attention capacity
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
standard of care arm
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).
"Diapason & Metronome" musical learning arm
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.
干预措施: "Diapason & Metronome" musical learning (Other)
结局指标
主要结局
attention capacity
时间窗: Baseline = Day 0 ; Month 6
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
次要结局
- Attentional deficits at 3 months after the start of the remediation (M3) and at 3 months post-remediation (M9)(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).(Baseline = Day 0 ; Month 6 and Month 9)