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

Abstract

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.

Music Therapy for Depression Enhanced With Listening Homework and Slow Paced Breathing: A Randomised Controlled Trial

“…We conducted a 2 × 2 factorial randomised controlled trial in which all clients received IIMT ( Erkkilä et al, 2019 ). The trial was registered (ISRCTN11618310) before recruitment.…”

“…Following a previous IIMT intervention, we assumed that no more than 10% of clients would leave the study early. We aimed to recruit 68 participants and allocate them into 4 conditions in a factorial design ( n = 34 in each condition; n = 17 in each group) ( Erkkilä et al, 2019 ). For each condition, the selected sample size provided statistical power of 0.80 for detecting a medium standardised effect size of Cohen’s d = 0.60 in a mixed-model analysis (see Twisk, 2013 , p. 281, equation 13.3), with a 2-tailed significance level of p < 0.05 and intra-participant correlation of ρ = 0.6.…”

“…Besides treatment effect post-intervention and follow-up, we obtained an overall treatment effect over time B as an estimate of the raw mean difference between presence and absence of each factor; B was calculated as the sum of the regression coefficients between each condition and time points ( Erkkilä et al, 2019 ). To estimate effect sizes for a given outcome, its overall treatment effect over time was divided by the standard deviation of the measure across all clients at baseline.…”

Music therapeutic emotional processing (MEP): Expression, awareness, and pain predict therapeutic outcome

“…The trial (Erkkilä et al, 2019) was designed to test the efficacy of two additional components that could be easily integrated to the general IIMT model: a breathing exercise at the beginning of each therapy session (resonance frequency breathing) and a homework task (listening to music therapy improvisations recorded in the sessions). Following a 2 × 2 factorial design, clients were randomly allocated to one of the four conditions via random integer generator.…”

Effect of Group Impromptu Music Therapy on Emotional Regulation and Depressive Symptoms of College Students: A Randomized Controlled Study

“…Adults with normal cognitive and abstract thinking abilities can associate the psychological content based on life experience with music expression in improvisation. And they can interpret or process these experiences according to the current situation ( Erkkila et al, 2019 ). Based on extensive practical research, many music therapists believe that music therapy has potential positive significance for emotional regulation ( Marik and Stegemann, 2016 ).…”