The PED-t trial protocol: The effect of physical exercise –and dietary therapy compared with cognitive behavior therapy in treatment of bulimia nervosa and binge eating disorder. Study protocol of a randomized controlled trial.

Abstract

Background: Sufferers from bulimia nervosa (BN) and binge eating disorder (BED) underestimate the severity risk of their illness and, therefore, postpone seeking professional help for years. Moreover, less than one in five actually seek professional help and only 50% respond to current treatments, such as cognitive behavioral therapy (CBT). The impetus for the present trial is to explore a novel combination treatment approach adapted from physical exercise- and dietary therapy (PED-t). The therapeutic underpinnings of these separate treatment components are well-known, but their combination to treat BN and BED have never been previously tested. The purpose of this paper is to provide the rationale for this new treatment approach and to outline the specific methods and procedures. Methods: The PED-t trial uses a prospective randomized controlled design. It allocates women between 18 and 40 years (BMI range 17.5–35.0) to groups consisting of 5–8 members who receive either CBT or PED-t for 16 weeks. Excess participants are allocated to a waiting list control group condition. All participants are assessed at baseline, post-treatment, 6, 12 and 24 months’ post-follow-up, respectively, and monitored for changes in biological, psychological and therapy process variables. The primary outcome relates to the ED symptom severity, while secondary outcomes relates to treatment effects on physical health, treatment satisfaction, therapeutic alliance, and cost-effectiveness. We aim to disseminate the results in high-impact journals, preferable open access, and at international conferences. Discussion: We expect that the new treatment will perform equal to CBT in terms of behavioral and psychological symptoms, but better in terms of reducing somatic symptoms and complications. We also expect that the new treatment will improve physical fitness and thereby, quality of life. Hence, the new treatment will add to the portfolio of evidence-based therapies and thereby provide a good treatment alternative for females with BN and BED. Trial registration: Prospectively registered in REC the 16th of December 2013 with the identifier number 2013/1871, and in Clinical Trials the 17th of February 2014 with the identifier number NCT02079935. Keywords: Eating disorders, RCT, Physical exercise, Dietary therapy, CBT, Treatment outcome, Physical fitness, Bone mineral density, Resistance exercise