Design proposal for a music therapy intervention to demonstrate its efficacy in severe mental disorders such as schizophrenic disorder a multicentre randomized and controlled clinical trial

Abstract

Background: Schizophrenia is one of the most prevalent and disabling psychiatric diseases. The treatment of schizophrenia relies not only on pharmacological interventions but also on various intervention programmes aimed at addressing the condition from an integrated and community-based perspective. Despite the existence of several psychosocial treatments whose effectiveness is well established, the potential benefits of including music therapy as an additional programme for these patients have not been sufficiently evaluated. Although there is evidence regarding the effects of music therapy on individuals, particularly those with mental health conditions, a standardised programme has yet to be implemented. Such a programme could potentially lead to improvements in patients' symptoms, quality of life, and functioning, as well as a reduction in the amount of pharmacological treatment required and the likelihood of readmissions. Aim: To analyse the effect of intervention with the music therapy programme on the improvement of symptoms in patients diagnosed with schizophrenia. Secondarily, it will also be of interest to determine its effect on quality of life, functioning, skills and social integration, as well as on the reduction of hospital admissions and pharmacological treatment. Methods: A multicentre, randomized, observer-blind, and controlled clinical trial will be performed. 102 patients diagnosed with schizophrenia from the Xarxa de Salut Mental of Girona will be consecutively and non-probabilistic recruited. They will be randomly assigned in 1:1 ratio to the intervention group (music therapy intervention) or control group (conventional care). The outcome variable (positive and negative symptoms) will be evaluated in both groups with the PANSS scale, and we will use the QLS, GAF, HoNOS scales to evaluate quality of life and functionality, and clarify if the music therapy intervention implies an improvement in these variables