Physical and mental health outcomes of an integrated cognitive behavioural and weight management therapy for people with an eating disorder characterized by binge eating and a high body mass index : a randomized controlled trial

Background: Bulimia nervosa (BN) and binge eating disorder (BED) are eating disorders (EDs) characterized by recurrent binge eating. They are associated with medical complications, impaired adaptive function and often a high BMI, for which a multidisciplinary treatment approach may be needed. This study explored the efficacy of a novel intervention integrating Cognitive Behavioural Therapy- Enhanced (CBT-E) and weight management for people with recurrent binge eating episodes and high BMI with respect to physical, psychopathological and quality of life outcomes. Methods: Ninety-eight adults diagnosed with BN, BED, or Other Specified/Unspecified Feeding or Eating Disorder (OSFED/UFED) and BMI ≥ 27 to <40 kg/m2 were randomized to a multidisciplinary approach, the Healthy APproach to weIght management and Food in Eating Disorders (HAPIFED) or to CBT-E. Metabolic parameters, health-related quality of life, general psychological and ED symptoms and ED diagnostic status outcomes are reported. Data were analyzed with mixed effects models adopting multiple imputed datasets where data were missing. Results: Both HAPIFED and CBT-E showed statistical significance for the time effect, with reduction in stress (p < 0.001), improvement in mental health-related quality of life (p = 0.032), reduction in binge eating severity (p < 0.001), and also in global ED symptoms scores (p < 0.001), with the significant changes found at end of treatment and sustained at 12-month follow-up. However, no statistical significance was found for differences between the interventions in any of the outcomes measured. Despite a high BMI, most participants (> 75%) had blood test results for glucose, insulin, triglycerides and cholesterol within the normal range, and 52% were within the normal range for the physical component of quality of life at baseline with no change during the trial period. Conclusion: Integrating weight and ED management resulted in comparable outcomes to ED therapy alone. Although adding weight management to an ED intervention had no adverse effects on psychological outcomes, it also had no beneficial effect on metabolic outcomes. Therefore, more intense weight management strategies may be required where indicated to improve metabolic outcomes. Safety will need to be concurrently investigated. Trial registration: US National Institutes of Health clinical trial registration number NCT02464345, date of registration 08/06/2015. Changes to the present paper from the published protocol paper (Trials 18:578, 2015) and as reported in the Trial registration (clinicaltrials.gov) are reported in Supplementary File 1

Baseline predictors of adherence in a randomised controlled trial of a new group psychological intervention for people with recurrent binge eating episodes associated to overweight or obesity

Purpose: Understanding the high rate of treatment adherence in trials of people with eating disorders is important as it can compromise the quality of the trials. In clinical practice, it may also contribute to illness chronicity, relapse, and costs. Thus, we investigated factors associated with adherence to a new treatment HAPIFED, which integrates cognitive behavioural therapy having extended sessions with body weight loss therapy compared to cognitive behavioural therapy with extended sessions alone, for individuals with Bulimia Nervosa or Binge Eating Disorder or other eating disorders comorbid with overweight or obesity. Methods: In total, 98 participants having bulimia nervosa, binge eating disorder and other specified and unspecified eating disorders were recruited with 50 randomised to HAPIFED and 48 to the control intervention CBT-E, all administered in groups of up to 10 participants. An investigator external to the site conducted the random allocation, which was concealed from the statistician involved in the analysis, and known only to the therapists until the finalization of the 12-month follow-up after the end of active treatment. Three scenarios in the timeline treatment of a total of 30 sessions were assessed: 33% or 60% or 75% of presence. Mixed-effects logistic regression analysis was performed to find the correlates of adherence after adjusting for clustering by number of group participants. To account for heterogeneity by types of eating disorders in the sample, the latter variable was considered as a control factor in the models. A subgroup analysis was performed for those with binge eating disorder as this was the largest (N = 66) eating disorder group. Results: None of the six variables—frequency of binge eating episodes, purging, eating disorder symptom severity, weight, illness duration and mental health-related quality of life—significantly predicted adherence at 33%, but longer illness duration predicted higher treatment adherence at both 60% and 75% presence of the interventions. Also for 75% presence, higher body weight predicted lower treatment adherence. For the subgroup analysis, those having higher illness duration had significantly higher odds of treatment adherence for 60% and 75% of the sessions. Conclusions: Higher adherence due to late treatment completion was associated with longer binge eating illness length and a lower body weight. More research is needed to recognize factors that may interfere with engagement in treatments aiming to avoid early dropout

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

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. Method/Design: 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/m2, 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. Discussion: 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. Trial registration: US National Institutes of Health clinical trial registration number NCT02464345 , date of registration 1 June 2015