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.