title: Comparing cognitive behavioural therapy for eating disorders integrated with behavioural weight loss therapy to cognitive behavioural therapy-enhanced alone in overweight or obese people with bulimia nervosa or binge eating disorder: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Around 40 % of individuals with eating disorders of recurrent binge eating, namely bulimia nervosa and binge eating disorder, are obese. In contrast to binge eating disorder, currently there is no evidence base for weight management or weight loss psychological therapies in the treatment of bulimia nervosa despite their efficacy in binge eating disorder. Thus, a manualised therapy called HAPIFED (Healthy APproach to weIght management and Food in Eating Disorders) has been developed. HAPIFED integrates the leading evidence-based psychological therapies, cognitive behavioural therapy-enhanced (CBT-E) and behavioural weight loss treatment (BWLT) for binge eating disorder and obesity respectively. The aim of the present study is to detail the protocol for a randomised controlled trial (RCT) of HAPIFED versus CBT-E for people with bulimia nervosa and binge eating disorder who are overweight/obese.
  
  
  METHODS
  A single-blind superiority RCT is proposed. One hundred Brazilian participants aged ≥ 18 years, with a diagnosis of bulimia nervosa or binge eating disorder, BMI > 27 to < 40 kg/m(2), will be recruited from both community and clinics and individually randomised to a therapy arm. Five groups of ten participants will receive the experimental intervention (HAPIFED) and the other five groups of ten the control intervention (CBT-E). Both therapies are manualised, and in this RCT will comprise 1 individual session and 29 office-based group sessions over 6 months. Assessment points will be at baseline, end of therapy, and 6 and 12 months after end of therapy. The primary outcome of this intervention will be reduced weight. Secondary outcomes will be improved metabolic indicators of weight management, reduction in eating disorder symptoms including improved control over eating, improved adaptive function, physical and mental health-related quality of life, and reduced levels of depression and anxiety.
  
  
  CONCLUSIONS
  This study will be the first to investigate a psychological therapy that aims to assist weight management in people with co-morbid overweight or obesity bulimia nervosa as well as with binge eating disorder. It will have the potential to improve health outcomes for the rapidly increasing number of adults with co-morbid obesity and binge eating disorder or bulimia nervosa.
  
  
  BACKGROUND
  US National Institutes of Health clinical trial registration number NCT02464345 , date of registration 1 June 2015.
authors.affiliation: Eating Disorders Programme (PROATA), Department of Psychiatry, Federal University of São Paulo (UNIFESP), São Paulo, Brazil. marlypalavras@gmail.com.|CAPES Foundation, Ministry of Education, São Paulo, Brazil. marlypalavras@gmail.com.|School of Medicine, Western Sydney University, Sydney, NSW, Australia. marlypalavras@gmail.com.
authors.forename: Marly Amorim
authors.initials: MA
authors.lastname: Palavras
authors.affiliation: CAPES Foundation, Ministry of Education, São Paulo, Brazil. P.Hay@westernsydney.edu.au.|Centre for Health Research, School of Medicine, Western Sydney University, Sydney, NSW, Australia. P.Hay@westernsydney.edu.au.
authors.forename: Phillipa
authors.initials: P
authors.lastname: Hay
authors.affiliation: School of Psychology, Faculty of Science, The University of Sydney, Camperdown, NSW, Australia. stephen.touyz@sydney.edu.au.
authors.forename: Stephen
authors.initials: S
authors.lastname: Touyz
authors.affiliation: The Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders, Sydney, NSW, Australia. amanda.salis@sydney.edu.au.|Medical School, and School of Psychology, The Faculty of Science, The University of Sydney, Camperdown, NSW, Australia. amanda.salis@sydney.edu.au.
authors.forename: Amanda
authors.initials: A
authors.lastname: Sainsbury
authors.affiliation: CAPES Foundation, Ministry of Education, São Paulo, Brazil. felipe.quintodaluz@sydney.edu.au.|The Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders, Sydney, NSW, Australia. felipe.quintodaluz@sydney.edu.au.|Medical School, and School of Psychology, The Faculty of Science, The University of Sydney, Camperdown, NSW, Australia. felipe.quintodaluz@sydney.edu.au.
authors.forename: Felipe
authors.initials: F
authors.lastname: da Luz
authors.affiliation: The Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders, Sydney, NSW, Australia. jessica.swinbourne@sydney.edu.au.|Medical School, and School of Psychology, The Faculty of Science, The University of Sydney, Camperdown, NSW, Australia. jessica.swinbourne@sydney.edu.au.
authors.forename: Jessica
authors.initials: J
authors.lastname: Swinbourne
authors.affiliation: Eating Disorders Programme (PROATA), Department of Psychiatry, Federal University of São Paulo (UNIFESP), São Paulo, Brazil. naramendes@post.harvard.edu.|CAPES Foundation, Ministry of Education, São Paulo, Brazil. naramendes@post.harvard.edu.
authors.forename: Nara Mendes
authors.initials: NM
authors.lastname: Estella
authors.affiliation: Eating Disorders Programme (PROATA), Department of Psychiatry, Federal University of São Paulo (UNIFESP), São Paulo, Brazil. angelica.claudino@uol.com.br.
authors.forename: Angélica
authors.initials: A
authors.lastname: Claudino
mesh_terms: D001521:Behavior Therapy / Q000379:methods*; D056912:Binge-Eating Disorder / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D015992:Body Mass Index; D001938:Brazil; D052018:Bulimia Nervosa / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D015897:Comorbidity; D004435:Eating; D005247:Feeding Behavior; D005260:Female; D006801:Humans; D008297:Male; D009765:Obesity / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D050177:Overweight / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012107:Research Design; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D015431:Weight Loss