title: Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: a study protocol for a randomised trial.
abstract: Functional somatic syndromes (FSS) are common in adolescents, characterised by severe disability and reduced quality of life. Behavioural treatments such as acceptance and commitment therapy (ACT) has shown promising results in children and adolescents with FSS, but has focused on specific syndromes such as functional pain. The current study will compare the efficacy of group-based ACT with that of enhanced usual care (EUC) in adolescents with a range of FSS operationalised by the unifying construct of multiorgan bodily distress syndrome (BDS).
  
  
  
  A total of 120 adolescents aged 15-19 and diagnosed with multiorgan BDS, of at least 12 months duration, will be assessed and randomised to either: (1) EUC: a manualised consultation with a child and adolescent psychiatrist and individualised treatment plan or (2) manualised ACT-based group therapy plus EUC. The ACT programme consists of 9 modules (ie, 27 hours) and 1 follow-up meeting (3 hours). The primary outcome is physical health, assessed by an Short Form Health Survey (SF-36) aggregate score 12 months after randomisation. Secondary outcomes include self-reported symptom severity, symptom interference, depression and anxiety, illness worry, perceived stress and global improvement; as well as objective physical activity and bodily stress response measured by heart rate variability, hair cortisol and inflammatory biomarkers. Process measures are illness perception, illness-related behaviour and psychological flexibility.
  
  
  
  The study is conducted in accordance with Helsinki Declaration II. Approval has been obtained from the Science Ethics Committee of the Central Denmark Region and the Danish Data Protection. The results will be sought to be published according to the CONSORT statement in peer-reviewed journals.
  
  
  
  This is one of the first larger randomised clinical trials evaluating the effect of a group-based intervention for adolescents with a range of severe FSS.
  
  
  
  NCT02346071; Pre-results.
authors.affiliation: Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Karen Hansen
authors.initials: KH
authors.lastname: Kallesøe
authors.affiliation: Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Andreas
authors.initials: A
authors.lastname: Schröder
authors.affiliation: Behavior Medicine Pain Treatment Services, Karolinska, Stockholm, Sweden.
authors.forename: Rikard K
authors.initials: RK
authors.lastname: Wicksell
authors.affiliation: Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Per
authors.initials: P
authors.lastname: Fink
authors.affiliation: Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Eva
authors.initials: E
authors.lastname: Ørnbøl
authors.affiliation: Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus, Denmark Regional Centre for Child and Adolescent Psychiatry, Risskov, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Charlotte Ulrikka
authors.initials: CU
authors.lastname: Rask
mesh_terms: D064869:Acceptance and Commitment Therapy; D000293:Adolescent; D000328:Adult; D001007:Anxiety / Q000628:therapy; D003863:Depression / Q000628:therapy; D015673:Fatigue Syndrome, Chronic / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D005260:Female; D005356:Fibromyalgia / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D005767:Gastrointestinal Diseases / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D006126:Group Processes; D006339:Heart Rate; D006801:Humans; D006854:Hydrocortisone / Q000378:metabolism; D007249:Inflammation / Q000097:blood; D008297:Male; D010146:Pain / Q000503:physiopathology / Q000523:psychology; D059408:Pain Management; D011788:Quality of Life; D012107:Research Design; D013312:Stress, Physiological; D013315:Stress, Psychological / Q000628:therapy; D013577:Syndrome; D055815:Young Adult
chemical_list: D006854:Hydrocortisone
keywords: Adolescents; Functional Somatic Syndromes; Medically Unexplained Symptoms; Psychotherapy; Randomised Controlled Trial; Study protocol