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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.

ABSTRACT: 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.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.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.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 .

SUBMITTER: Mathisen TF

PROVIDER: S-EPMC5427572 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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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.

Mathisen Therese Fostervold TF Rosenvinge Jan H JH Pettersen Gunn G Friborg Oddgeir O Vrabel KariAnne K Bratland-Sanda Solfrid S Svendsen Mette M Stensrud Trine T Bakland Maria M Wynn Rolf R Sundgot-Borgen Jorunn J

BMC psychiatry 20170512 1

<h4>Background</h4>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). Th ...[more]

PMID: 28494809

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Project description:PurposeChaotic eating and purging behavior pose a risk to the metabolic health of women with bulimia nervosa (BN) and binge-eating disorder (BED). This study reports on one-year changes in blood markers of metabolic health and thyroid hormones in women with BN or BED attending two different treatments.MethodsThese are secondary analyses from a randomized controlled trial of 16-week group treatment of either physical exercise and dietary therapy (PED-t) or cognitive behavior therapy (CBT). Blood samples collected at pre-treatment, week eight, post-treatment, and at 6- and 12-month follow-ups were analyzed for glucose, lipids (triglycerides (TG), total cholesterol (TC), LDL cholesterol (LDL-c), HDL cholesterol (HDL-c), apolipoprotein A (ApoA) and apolipoprotein B (ApoB) lipoproteins), and thyroid hormones (thyroxine (T4), thyroid stimulating hormone (TSH), and thyroperoxidase antibodies).ResultThe average levels of blood glucose, lipids and thyroid hormones were within the recommended range, but clinical levels of TC and LDL-c were detected in 32.5% and 39.1%, respectively. More women with BED compared with BN had low HDL-c, and a larger increase over time in TC and TSH. No significant differences occurred between PED-t and CBT at any measurement. Exploratory moderator analyses indicated a more unfavorable metabolic response at follow-up among treatment non-responders.ConclusionThe proportion of women with impaired lipid profiles and unfavorable lipid changes, suggests active monitoring with necessary management of the metabolic health of women with BN or BED, as recommended by metabolic health guidelines.Level of evidenceLevel I: Evidence obtained from a randomized, experimental trial.Trial registration numberThis trial was prospectively registered in the Norwegian Regional Committee for Medical and Health Research Ethics on December 16, 2013, with the identifier number 2013/1871, and in Clinical Trials on February 17, 2014, with the identifier number NCT02079935.

Project description:BackgroundCurrent guidelines recommend cognitive behavior therapy (CBT) as the treatment of choice for binge eating disorder (BED). Although CBT is quite effective, a substantial number of patients do not reach abstinence from binge eating. To tackle this problem, various theoretical conceptualizations and treatment models have been proposed. Dialectical behavior therapy (DBT), focusing on emotion regulation, is one such model. Preliminary evidence comparing DBT adapted for BED (DBT-BED) to CBT is promising but the available data do not favor one treatment over the other. The aim of this study is to evaluate outcome of DBT-BED, compared to a more intensive eating disorders-focused form of cognitive behavior therapy (CBT+), in individuals with BED who are overweight and engage in emotional eating.MethodsSeventy-four obese patients with BED who reported above average levels of emotional eating were quasi-randomly allocated to one of two manualized 20-session group treatments: DBT-BED (n = 41) or CBT+ (n = 33). Intention-to-treat outcome was examined at post-treatment and at 6-month follow-up using general or generalized linear models with multiple imputation.ResultsOverall, greater improvements were observed in CBT+. Differences in number of objective binge eating episodes at end of treatment, and eating disorder psychopathology (EDE-Q Global score) and self-esteem (EDI-3 Low Self-Esteem) at follow-up reached statistical significance with medium effect sizes (Cohen's d between .46 and .59). Of the patients in the DBT group, 69.9% reached clinically significant change at end of the treatment vs 65.0% at follow-up. Although higher, this was not significantly different from the patients in the CBT+ group (52.9% vs 45.8%).ConclusionsThe results of this study show that CBT+ produces better outcomes than the less intensive DBT-BED on several measures. Yet, regardless of the dose-difference, the data suggest that DBT-BED and CBT+ lead to comparable levels of clinically meaningful change in global eating disorder psychopathology. Future recommendations include the need for dose-matched comparisons in a sufficiently powered randomized controlled trial, and the need to determine mediators and moderators of treatment outcome.Trial registrationNederlands Trial Register: NL3982 (NTR4154). Date of registration: 2013 August 28, retrospectively registered.

Project description:BackgroundEating disorders affect 13% of females and contribute to functional impairment and mortality, but few studies have identified risk factors that prospectively correlate with future onset of anorexia nervosa (AN), bulimia nervosa (BN), binge eating disorder (BED), and purging disorder (PD). Identifying risk factors specific to each eating disorder is critical for advancing etiologic knowledge and designing effective prevention programs.ObjectivesThis study examined whether weight suppression (the difference between a person's highest past weight at their adult height and their current weight) correlates with future onset of AN, BN, BED, and PD.MethodsData from 1165 young women with body image concerns (mean ± SD age: 21.9 ± 6.4 y) who completed annual diagnostic interviews over a 3-y follow-up period were examined. Logistic regression models evaluated the relation of baseline weight suppression to onset risk of each eating disorder controlling for age, dietary restraint, and intervention condition.ResultsElevated weight suppression predicted future onset of AN (OR: 1.36; 95% CI: 1.03, 1.80), BN (OR: 1.34; 95% CI: 1.11, 1.62), PD (OR: 1.46; 95% CI: 1.23, 1.74), and any eating disorder (OR: 1.32; 95% CI: 1.12, 1.56), but not BED (OR: 1.10; 95% CI: 0.89, 1.37). Highest past weight correlated with future onset of BN and PD but not onset of AN, BED, or any eating disorder, and baseline current weight was inversely related to future AN onset only, implying that women with the largest difference between their highest past weight and current weight are at greatest risk of eating disorders.ConclusionsThe results provide novel evidence that weight suppression correlates with future onset of eating disorders characterized by dietary restriction or compensatory weight control behaviors and suggest weight-suppressed women constitute an important risk group to target with selective prevention programs.These trials were registered at clinicaltrials.gov as NCT01126918 and NCT01949649.

Dataset Information

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.

Publications

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.

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