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Background  Depression is among the leading causes of disability worldwide. Not all people with depression respond adequately to standard treatments. An innovative therapy that has shown promising results in controlled trials is music therapy. Based on a previous trial that suggested beneficial effects of integrative improvisational music therapy (IIMT) on short and medium-term depression symptoms as well as anxiety and functioning, this trial aims to determine potential mechanisms of and improvements in its effects by examining specific variations of IIMT.    Methods/design  A 2 × 2 factorial randomised controlled trial will be carried out at a single centre in Finland involving 68 adults with a diagnosis of depression (F32 or F33 in International Statistical Classification of Diseases and Related Health Problems 10th revision). All participants will receive 6 weeks of bi-weekly IIMT, where they are invited to improvise music and reflect on those improvisations with a music therapist in a one-to-one setting. Potential enhancements to IIMT will include: home-based listening to recorded improvisations (LH) from IIMT sessions to facilitate integration of therapeutic processing into daily life; and resonance frequency breathing (RFB), a breathing exercise at the beginning of each session to facilitate emotional expression and processing. Participants will be randomised in a 1:1:1:1 ratio into each combination (IIMT alone or with one or both enhancements). The primary outcome is depressive symptoms measured by the Montgomery–Åsberg Depression Rating Scale (MADRS) at 6 weeks. Secondary outcomes are depressive symptoms at 6 months; anxiety, quality of life, and functioning at 6 weeks and 6 months; and adverse events. Secondary underlying mechanisms/process variables are self-rated momentary depression level before every IIMT session; and homework compliance in IIMT + LH. Statistical analyses involve an intention-to-treat approach, using a linear mixed-effects model examining the main effects (LH vs no LH; RFB vs no RFB) and interaction effects (LH × RFB).    Discussion  This trial will contribute to understanding the mechanisms of IIMT and may further enhance the effectiveness of an intervention that was previously shown to be superior to standard care alone for adults with depression.    Trial registration   ISRCTN11618310 . Registered on 26 January 2018.

Enhancing the efficacy of integrative improvisational music therapy in the treatment of depression: study protocol for a randomised controlled trial