High-Frequency vs. Low-Frequency Music Therapy in Psychiatric Inpatients: A Randomized Controlled Trial

Introduction Music therapy is an evidence-based clinical intervention with demonstrated efficacy in reducing anxiety and depression and in neuromodulation that promotes well-being. Sessions are usually delivered weekly. Psychiatric hospital stays are progressively shorter, requiring interventions to be delivered in brief intensive schemes. Our objective was to evaluate the effectiveness of a high-frequency intervention music therapy (5 sessions/week) compared to a low-frequency (1 session/week) control group.

This is a randomized controlled clinical trial in patients with mental disorders under in-hospital psychiatric treatment. A computer-based random generator created a random allocation sequence to guarantee equal group assignment probability. The primary outcome was symptoms in the Depression/Anxiety/Stress Scale of 21 items (DAS-21). Secondary outcomes were the impact of music therapy sessions on adult patients measured with the CISMA questionnaire (CISMA by Spanish acronyms), and global life satisfaction with the single item for measuring overall life satisfaction (SWLS). To mitigate risks associated with the interventions, at least one healthcare professional will attend each session, alongside a certified music therapist. The Shapiro-Wilk test was used to test the distribution of variables. We used the Mann-Whitney U test to prove differences between groups and the Wilcoxon signed-rank test differences within groups. Spearman’s test was performed to determine the correlation between continuous variables. Statistical analysis was performed with Jamovi (version 2.6, 2024).

Patients in the intervention group had a significant stress level reduction compared to the control group (p=0.033). Both groups experienced significant improvements in anxiety, depression, and global life satisfaction. In addition, positive expectations towards music therapy were associated with greater symptom reduction (r=-0.33, p=0.004).

To the best of our knowledge, this study is the first randomized controlled trial comparing high-frequency and low-frequency music therapy for psychiatric inpatients. Although both groups demonstrated significant improvement in all the outcomes measured, only the high-frequency group demonstrated greater benefit for stress symptoms. Changes in physiological stress have been reported previously, concordant with our psychological findings. Music therapy had a probable suggestive effect on symptom reduction. These findings highlight the potential of music therapy for stress management in psychiatric hospitals but emphasize the need for further research to standardize session intensity and treatment duration. Trial Registration: ISRCTN registry: ISRCTN87861817 (https://www.isrctn.com/ISRCTN87861817) Competing Interest Statement The authors have declared no competing interest. Clinical Trial ISRCTN87861817 Funding Statement The author(s) received no specific funding for this work. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: On July 26, 2024, as recorded in Act 209, "The Ethics Committee in Research of C.E.I. CAMPO ABIERTO LTDA" reviewed and approved Research protocol, Informed consent document,and all instruments. C.E.I Campo Abierto LTDA. Tel: +57 310 697 4943 email: eticaeninvestigacion{at}hotmail.com I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability All data files are available from the OSF Storage database (Ferro, E. 2024, October 15). High-Frequency vs Low-Frequency Music Therapy in Psychiatric Inpatients: A Randomized Controlled Trial. https://doi.org/10.17605/OSF.IO/384FB