Treatment Fidelity in a Music Therapy Multi-site Cluster Randomized Controlled Trial for People Living With Dementia: The Middel Project Intervention Fidelity Protocol


Journal of Music Therapy




High-quality clinical trials testing music therapy interventions have become more prevalent over the past decade. However, recent reviews of published music therapy trials reveal that reporting of strategies used to ensure treatment fidelity is lacking. Treatment fidelity refers to methodological strategies, put in place prior to clinical trial implementation, to strengthen the reliability and validity of intervention delivery and, therefore, safeguard research quality. This paper outlines strategies developed and implemented during the pilot phase of a randomized controlled trial involving the testing of music interventions for people living with dementia and presenting with symptoms of depression. We discuss the five recognized components of fidelity (study design, training intervention providers, treatment integrity, treatment differentiation, and treatment receipt) and describe our methods for training music intervention providers and testing interventionist competence prior to trial commencement, approaches to intervention delivery supervision, and methods for assessing intervention protocol adherence.

Music and Health Institute Terms

Dementia; Depression; Mental Health; Music Listening; Music Medicine; Neurodegenerative Disorders; Psychological Outcomes; Recorded Music Listening

Indexed Terms

Clinical Trial Protocols as Topic; Dementia; Depression; Quality of Life; Reproducibility of Results; Research Design; dementia; depression; fidelity; protocols

Study Type

Quantitative Methods; Randomized Controlled Trial

PubMed ID


Document Type