This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
Most studies reporting treatment outcomes for eating disorders at higher levels of care focus on anorexia nervosa and bulimia nervosa. No studies have been published with a singular focus on examining treatment outcomes for adults receiving residential programming specifically designed for the treatment of binge eating spectrum disorders (BESD), including binge eating disorder and bulimia nervosa.
The purpose of this paper is to outline the protocol of a prospective study examining treatment outcomes at discharge and 3-month, 6-month, and 12-month postdischarge follow-up, for a sample of consecutive admissions to a residential program specifically for patients with BESD.
One hundred consecutive admissions to a binge eating treatment program were enrolled in the prospective single-arm trial between January 2019 and February 2020. Data were collected at admission, discharge, and 3, 6, and 12 months postdischarge, with admission, discharge, and 12-month follow-up as the major timepoints of interest. Results across the major timepoints will be analyzed with mixed effects general linear models.
The primary aim is to assess the impact of the program on eating disordered behaviors at discharge and 12-month follow-up, which are hypothesized to improve as a result of treatment. Secondary hypotheses include improvements on comorbid symptoms, including trauma, depression, and obsessive-compulsive symptoms, as well as improvements on medical indicators of health, including cholesterol and triglycerides, at discharge and 12-month follow-up.
This study may aid in the development of treatment guidelines for patients with BESD at higher levels of care and lend support to having specialty treatment programs for patients with BESD.
DERR1-10.2196/32270
Binge eating disorder (BED) is defined as recurrent episodes of binge eating in the absence of compensatory behaviors, accompanied by marked distress regarding the binge eating [
Residential treatment provides 24/7 care focused on psychological/behavioral interventions (as opposed to medical stabilization, which is the focus of inpatient treatment). A systematic review of 19 residential eating disorder treatment programs reported that only 14% of the reviewed studies included patients with BED [
One of the few studies reporting results separately for BED was from a residential treatment program for obesity, examining patients with and without BED at 6-month and 5-year follow-up [
Outcomes for patients with BN are reported more frequently than outcomes for patients with BED, although BN outcomes are often not reported separately from other eating disorder diagnoses, with results reported for the overall sample instead. Residential programs that have reported results separately for patients with BN often find stability in BMI over time and improvements in eating disorder psychopathology and depression [
Although there are no widely agreed upon essential elements of residential treatment for BED, in their review of residential programs across eating disorder diagnoses, Peckmezian and Paxton [
Most residential programs are generally designed for patients across the eating disorders spectrum. No studies have been published with a singular focus on examining treatment outcomes for adults receiving residential programming specifically designed for the treatment of BESD. The purpose of this paper is to describe the detailed protocol of a study prospectively examining treatment outcomes for a sample of consecutive admissions to a residential program specifically for patients with BESD (BED or BN). Patients with AN – binge/purge subtype (AN-BP) were not included in the binge eating disorder treatment program described in this paper, given the need for a different treatment focus for this patient population, including weight restoration.
It is hypothesized that meaningful improvements (defined here as pre- to posttreatment change with at least a medium Cohen
It is also hypothesized that meaningful improvements will be demonstrated on a measure of experiential avoidance of weight-related feelings, thoughts, and actions, although no a priori hypotheses are made as to which subscales may improve the most. Depression, dysfunctional attitudes, and quality of life are also expected to meaningfully improve. Small improvements (defined here as pre- to posttreatment change with at least a small Cohen
This study is a prospective pragmatic single-arm trial with consecutive admissions. As with all pragmatic trials, the primary goal of this study was to observe unbiased patient outcomes in a real-world setting. Given the acuity of patients, and the lack of an evidence-based treatment as usual for patients with BESD at this level of care, it was neither feasible nor ethical to execute a randomized or nonrandomized design with a treatment as usual or nontreatment comparison condition. To minimize bias from retrospective reports and convenience samples, this study was devised prospectively to examine outcomes in 100 consecutive admissions who agreed to participate.
One hundred consecutive admissions to the Binge Eating Treatment & Recovery (BETR) residential program in a large Midwestern city in the United States who consented to participate were enrolled in this study. The BETR program is part of Eating Recovery Center’s (ERC) network of eating disorder treatment programs. ERC is a multisite, national program offering higher levels of care to patients with eating disorders. Treatment is provided by multidisciplinary teams of a physician, licensed psychotherapist, psychiatrist, and registered dietitian, with a focus on evidence-based group therapies. Participants were approached to participate in the study within the first 3 days of their admission date.
Inclusion criteria for patients admitting to the BETR treatment program are the following: (1) age ≥18 years, (2) have binge eating as a predominant symptom associated with their primary or secondary diagnosis at admission, and (3) voluntary consent for treatment from the patient. Patients were recommended for residential level of care (as opposed to partial hospitalization programming) if they had prominent mood and anxiety symptoms (ie, nonsuicidal self-injury, suicidality, sleep disturbance) associated with their eating disorder and/or if they lacked support for recovery in their home environments. Other inclusion criteria included severity of eating disorder symptoms, abnormalities in initial labs, or poorly controlled medical conditions that were exacerbated by eating disorder symptoms (ie, diabetes mellitus), sleep-related disturbances, or nocturnal-related eating. Exclusion criteria that prevented patients from admitting to the BETR treatment program are the following: (1) primary substance use or psychotic disorder, (2) active psychosis, (3) immobility (patients could not be bedbound, and needed to be able to perform activities of daily living independently or with some nursing assistance), (4) high risk for refeeding syndrome or need for refeeding secondary to restriction, due to the lack of capacity for tube feeds/lack of focus on refeeding on the unit, and (5) need for inpatient medical stabilization. Additionally, and without regard to this study, patients are always asked (but never required) to complete a battery of self-report measures at admission and discharge. An additional inclusion criterion for this study was consent to participate in this study in addition to treatment, including providing self-report data and lab draws while in treatment and during follow-up posttreatment. Exclusion criteria for the study were (1) unwillingness to provide informed consent, and (2) the presence of any intellectual disability, cognitive deficit, or physical incapacitation that may have prevented participants from understanding or completing the informed consent process or completing assessment measures.
In addition to the standard admission and discharge questionnaires, and standard treatment described below, the 100 consecutive admissions for this study were asked to follow additional data collection procedures and were reimbursed accordingly. In addition to admission and discharge questionnaires, patients were asked to complete 6-month and 12-month follow-up self-report questionnaires. Patients were also asked to visit a laboratory facility at 3-month and 6-month follow-up to obtain a blood draw for a lipid panel (total cholesterol, HDL, LDL, triglycerides) and HbA1c. Participants received a US $25 Amazon gift card after completion of each of their admission and discharge assessments, and a US $100 Amazon gift card after the 6-month and 12-month follow-up intervals, for a possible total of US $250 in gift cards for completing all assessments.
This study was approved by Salus Institutional Review Board in January 2019 (approval number: ERC-001) and procedures followed were in accordance with the ethical standards of the institutional review board on human experimentation and the Helsinki Declaration of 1975.
The BETR program is designed to specifically serve the needs of patients struggling with BESD. A case report suggested that having patients with BESD participate in treatment programs designed primarily for restrictive eating disorders may be problematic due to differing foci of weight restoration versus normalizing eating patterns, as well as patients’ comparisons to other patients, which can be detrimental to recovery [
Patients receive personalized treatment from a multidisciplinary team for biweekly individual therapy, biweekly psychiatry visits, weekly family therapy, and weekly dietary sessions. Additionally, patients meet with a primary care physician, certified exercise physiologist, case manager, behavioral health counselors, and nurses upon admission and as needed. The registered dietitian and physician jointly decide on meal plans based on patients’ treatment goals and medical conditions. Patients participate in 3 supported meals and 2-3 supported snacks daily. Treatment is focused on regulating eating and treating body image disturbance. The exercise philosophy is on increasing joyful and intuitive movement, increasing mobility when needed, decreasing body shame, and decreasing overexercise or compulsive exercise when present.
In addition to interrupting eating disordered behavior, treatment also focuses on managing comorbid conditions, such as mood and anxiety disorders, and regulating sleep. Patients participate in daily group therapy based on a range of treatment modalities, including enhanced CBT (CBT-E) [
The Eating Pathology Symptoms Inventory (EPSI) [
The Binge Eating Scale (BES) [
The Night Eating Questionnaire (NEQ) [
The Acceptance and Action Questionnaire for Weight-Related Difficulties – Revised (AAQW-R) [
The Eating Disorders Quality of Life (EDQOL) instrument [
The Beck Depression Inventory-II (BDI-II) [
The Obsessive-Compulsive Inventory – Revised (OCI-R) [
The State-Trait Anxiety Inventory (STAI) [
The Rosenberg Self-Esteem Scale (RSE) [
The Dysfunctional Attitudes Scale – Short Form (DAS-SF 1) [
The PTSD Checklist for DSM-5 (PCL-5) [
The Adverse Childhood Experiences Survey (ACES) [
At 3 and 6 months postdischarge, patients obtained a blood draw for a lipid panel (total cholesterol, HDL, LDL, triglycerides) and HbA1c. Patients were weighed weekly or twice weekly depending on insurance requirements and symptom presentation (ie, active purging was monitored more frequently with weights and labs). All weight collection was blind. “Blind weighing” involves not sharing weight data with the patient to minimize potential distress that may occur from the patient seeing his or her weight [
Timeline of collection for labs and questionnaires.
|
Baseline | Discharge | 3-month follow-up | 6-month follow-up | 12-month follow-up | |
|
|
|
|
|
|
|
|
Total cholesterol | x |
|
x | x |
|
|
High density lipoprotein | x |
|
x | x |
|
|
Low density lipoprotein | x |
|
x | x |
|
|
Triglycerides | x |
|
x | x |
|
|
Glycated hemoglobin | x |
|
x | x |
|
|
|
|
|
|
|
|
|
Eating Pathology Symptoms Inventory | x | x |
|
x | x |
|
State-Trait Anxiety Inventory | x | x |
|
x | x |
|
Acceptance and Action Questionnaire for Weight-Related Difficulties – Revised | x | x |
|
x | x |
|
Beck Depression Inventory-II | x | x |
|
x | x |
|
Binge Eating Scale | x | x |
|
x | x |
|
Dysfunctional Attitudes Scale – Short Form | x | x |
|
x | x |
|
Eating Disorders Quality of Life | x | x |
|
x | x |
|
Night Eating Questionnaire | x | x |
|
x | x |
|
Obsessive-Compulsive Inventory – Revised | x | x |
|
x | x |
|
PTSD Checklist for DSM-5 | x | x |
|
x | x |
|
Rosenberg Self-Esteem Scale | x | x |
|
x | x |
All data at admission, discharge, and 3, 6, and 12 months postdischarge will be aggregated for the full sample and examined for patterns of missingness, outliers (>3 standard deviations from mean), and normality of distributions. Our a priori assumptions are that data will be missing at random, and all data will be normally distributed with the appropriately minimal proportion of outlier data points. Mixed models will be used to examine fixed and random effects of linear within-person change in BDI-II, EDQOL, OCI-R, STAI, RSE, DAS-SF, PCL-5, BES, and NEQ across our major timepoints of interest (admission, discharge, and 12-month follow-up). Mixed models will be run both unadjusted, as well as adjusted for person-level variables of BMI at admission, demographic variables of age, race/ethnicity, and gender, and diagnosis. Lastly, to examine the potential for different trajectories within-treatment and posttreatment, nested model comparisons will be conducted comparing the linear mixed models described above with mixed models including a quadratic time variable. Based on an expected effect size of at least
All data at each of these timepoints will also be subset by patients above and below the threshold for history of trauma (defined as an ACES score ≥4) and above and below the most commonly established threshold for clinically significant levels of PTSD symptoms via the PCL-5 (PCL-5 ≥33) [
Recruitment of participants began in January 2019 and ended in February 2020. Data collection was completed in May 2021. Data analysis is expected to begin in April 2022, and results are expected to be published in fall 2022. The study was internally funded by ERC.
The treatment program described in this study is unique in that it is developed specifically for, and solely treats, patients with BESD at the residential level of care. It is expected that this program, tailored to the needs of patients with BESD, will result in improvement in eating disorder psychopathology, comorbid mood and anxiety symptoms, quality of life, and improvement in physiological measures of health as a result of changes in eating disordered behaviors.
Several practical challenges in evaluating real-world treatment make it important to develop a protocol and explicitly state a priori intentions and expectations. First, the lack of a control group makes it difficult to assess a program’s effectiveness. Nevertheless, our a priori hypotheses on the
This study may aid in the development of treatment guidelines for patients with BESD at higher levels of care and lend support to having specialty treatment programs for patients with BESD. Further, it may aid in improving insurance coverage for BESD, which tends to be less favorable than that for patients with AN or BN who are in treatment at ERC. Future studies should further examine components of treatment programs to determine which elements are most critical to recovery.
Acceptance and Action Questionnaire for Weight-Related Difficulties – Revised
adverse childhood experience
Adverse Childhood Experiences Survey
acceptance and commitment therapy
anorexia nervosa
anorexia nervosa – binge/purge subtype
Beck Depression Inventory-II
binge eating disorder
Binge Eating Scale
binge eating spectrum disorders
Binge Eating Treatment & Recovery
bulimia nervosa
cognitive-behavioral therapy
enhanced cognitive-behavioral therapy
Dysfunctional Attitudes Scale – Short Form
dialectical behavior therapy
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
Eating Disorders Quality of Life
Eating Pathology Symptoms Inventory
Eating Recovery Center
glycated hemoglobin
high density lipoprotein
low density lipoprotein
Night Eating Questionnaire
Obsessive-Compulsive Inventory – Revised
PTSD Checklist for DSM-5
posttraumatic stress disorder
Rosenberg Self-Esteem Scale
State-Trait Anxiety Inventory
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. DVB was supported by Career Development Award 19–035 (IK2HX003085-01A2) from the United States Department of Veterans Affairs Health Services Research and Development (HSR&D) Service.
RDR receives consulting fees from the Training Institute for Child and Adolescent Eating Disorders LLC and receives royalties from Routledge. DLG receives royalties from Guilford Press and Routledge, is Co-Director of the Training Institute for Child and Adolescent Eating Disorders LLC, and is a member of Equip Health Clinical Advisory Board. DVB consults for Eating Recovery Center. All other authors declare no conflicts of interest.