Music Therapy vs. Music Listening for Negative Symptoms in Schizophrenia: Randomized, Controlled, Assessor- and Patient-Blinded Trial.

Objective: To investigate the efficacy of music therapy for negative symptoms in patients with schizophrenia. Methods: Randomized, participant- and assessor-blinded, multicenter, controlled trial including patients diagnosed with schizophrenia according to ICD-10 with predominantly negative symptoms, between 18 and 65 years. Participants were randomized to 25 successive weekly individual sessions (excluding holidays, including cancellation by the participant) of either music therapy conducted by trained music therapists, or music listening together with a social care worker. The primary outcome was reduction in negative symptoms as measured by The Positive and negative Syndrome Scale (PANSS) negative subscale total score, assessed by a blinded rater, utilizing mixed-effects model analysis. Results: In total, 57 participants were randomized; 39 completed the study's initial 15 weeks, and 30 completed follow-up at 25 weeks. On the primary outcome of PANSS negative subscale, no significant difference was observed between groups with a coefficient of -0.24 (95% CI -1.76 to 1.27, P = 0.754) in the intention to treat analysis, and -0.98 (95% CI -5.06 to 3.09, P = 0.625) when only analyzing completers. Both interventions showed significant reduction from baseline to 25 weeks on PANSS negative subscale. On secondary outcomes, no between group differences were observed in The Brief Negative Symptom Scale, WHOQOL-Bref (Quality of Life), The Helping Alliance Questionnaire and The Global Assessment of Functioning in the intention to treat or completers populations utilizing Mixed Effects Models. Conclusion: No difference between groups randomized to music therapy vs. musical listening was observed resulting in no clear recommendation for which intervention to use as the first choice for treatment of patients diagnosed with schizophrenia and predominantly having negative symptoms. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02942459.

Music Therapy as Treatment of Negative Symptoms for Adult Patients Diagnosed with Schizophrenia-Study Protocol for a Randomized, Controlled and Blinded Study.

Background: Three Cochrane reviews show that music therapy has a positive effect on schizophrenia concerning general functioning and positive/negative symptoms. This study aims to replicate these results in the Danish health system, a requirement for recommendation in guidelines from the Danish National Board of Health. Methods: The study is a randomized, controlled multi-site study, with a blinded design, aiming to include 90 participants who are 18⁻65 years in age, diagnosed according to ICD-10 with a schizophrenia diagnosis. The participants are randomized to one of two different music therapy activities for 25 weekly sessions. The study interventions are added to standard care. Outcome measures are rated at baseline, after 15 sessions and post therapy. A qualitative interview is performed as a one month follow up at the end of study. The primary intended outcome is a reduction in negative symptoms. The secondary intended outcome is progression in quality of life, alliance and psychosocial functioning. Results: As this study is still running, the results are not yet available. Conclusion: The study will investigate the direct effects of music therapy on negative symptoms as part of schizophrenia in a blinded, randomized trial. If proven effective, music therapy can be added to the small treatment armamentarium of effective therapies for negative symptoms in patients with schizophrenia.