Mental training for chronic fatigue syndrome (CFS/ME) following EBV infection in adolescents: a randomised controlled trial 1. Introduction

ion from immediate and concrete experience. New feelings and symbolic meaning emerge, and these novelties can especially be explored through music, as a multi-layered phenomenon (Frohne-Hagemann, 2015; Trondalen, 2015 to be published). There is a long tradition of music therapy based on cognitive principles in the USA (Bonde, Trondalen & Wigram, 2014; Standley et al, 2004). However, in Scandinavia music therapy has been based more on either psychodynamic, humanistic-existential or community principles (Bonde, 2014; Trondalen & Ruud, 2008). Combinations of music therapy and CBT, or integrating elements of CBT in music therapy, have recently been tried out in different clinical contexts, especially in psychiatry (Lund, 2012; Moe, 2007). Important elements in such integrated approaches are: a) the implementation of cognitive techniques and methods in the sessions, e.g. ideas from Acceptance & Commitment Therapy, “examining the value system”, the “cognitive diamond”, working with lists of positive and negative events and thoughts, formulation of specific goals and activities; b) the inclusion of homework (the patient works min 15 min/day on music-related tasks, such as writing lyric notes, identifying helpful music, doing music/relaxation exercises). Music therapy together with mindfulness supports an individual process allowing the music to take the patient where she needs to go in the moment. Mindfulness – like music — is experiential, allowing the patient to being aware in a non-attached and non-judgmentally way of things that happens in the moment (Kabat-Zinn, 2003). In music listening the exploration of feelings, memories, thoughts and perspectives that arise in response to the music can be accepted, understood and integrated into a renewed self-understanding (Trondalen & Oveland, 2008; Van Dort, 2015). Treatment and prognosis Although six months disease duration is considered sufficient for a diagnosis of CFS/ME (IOM 2015; Fukuda 1994, Carruthers 2011), most adolescents experience a considerable longer time period from the début of CFS/ME symptoms until a definite diagnosis is made (Knight et al. 2013). This protracted period is related to severe functional disability, and may also have a negative impact on prognosis (Joyce 1997, Werker 2013). These facts favor initiation of treatment at an early stage; however, to the best of our knowledge, no prior study has addressed the importance of early intervention for CFS/ME. 3. Aims This study explores the effect of an individually tailored, multidisciplinary mental training program (in which CBT and music therapy are the main elements) to adolescents suffering from CFS/ME after EBV-infection. The general aims are: a. To explore the clinical effect of the training program, in particular the effect on physical activity (primary endpoint) and symptoms (fatigue, pain, insomnia). b. To explore the effect of the training program on important elements in CFS/ME pathophysiology, such as cardiovascular autonomic control, the HPA-axis, inflammation, cognition, affect consciousness and functional brain networks. Taken together, the study will provide important knowledge on clinical handling (aim a.) as well as disease mechanism (aim b.). Furthermore, it addresses the criticism regarding heterogeneity of precipitating factors and lack of biomarkers in clinical trials, and it explores the importance of early intervention. Finally, the individually tailored, multidisciplinary approach in the treatment group, as well as the routine follow-up in the control group are close to clinical everyday settings, giving the study high external validity.