Building an Equitable and Accessible System of Eating Disorder Care for VA, DoD, and Underrepresented Americans

Official title

Building an Equitable and Accessible System of Eating Disorder Care for VA, DoD, and Underrepresented Americans With Eating Disorders (EASED Study)

Overview

When untreated, eating disorders present with tremendous burdens to affected active duty Service members and Veterans and their families, and are very costly to the DoD and VA healthcare system. A comparative effectiveness study with state-of-the-art virtual treatment for BN and BED specifically adapted for testing with the Veteran population and other underrepresented eating disorder populations will lead to major improvements in clinical outcomes. The treatment will be integrated with VA's newest telehealth technology to profoundly enhance access to care anywhere, at any time. This trial of therapist-led and self-help CBT treatments, combined with our expert panel methods to inform VA Clinical Practice Guidelines for Eating Disorders and plans for dissemination, will accelerate the pace for the transition of results both for large-scale deployment in the VA system and for real-world impact among diverse and underrepresented eating disorder populations.

Detailed description

The overall objective is to test and improve access to evidence-based eating disorder treatment for active duty Service members and Veterans. The two-part project will include a comparative effectiveness trial of virtual treatments followed by qualitative methods for implementation. The randomized controlled trial will specifically test the effectiveness of Telehealth Cognitive Behavioral Therapy (TeleCBT) compared to Self-Help Cognitive Behavioral Therapy (shCBT) for binge eating disorders.

* Aim 1 (Superiority): To assess the effectiveness of TeleMental Health CBT (TeleCBT) compared to Self-Help CBT (shCBT) for decreasing binge frequency (primary) and improving eating behavior and mental health outcomes.

1. It is hypothesized that Veterans in TeleCBT will have greater reductions in binge frequency, and greater percentage of participants who are binge remitted, than Veterans in shCBT. 2. It is further hypothesized that TeleCBT will have better outcomes on purging behavior (among those with BN), eating pathology, symptoms of depression and trauma, and quality of life than shCBT. * Aim 2 (Process): To assess demographic (age and gender) and clinical (clinical severity and comorbidity) characteristics as potential predictors, moderators and correlates of treatment outcome. * Aim 3 (Implementation): To inform VA Clinical Practice Guidelines for Eating Disorders by convening a panel of experts and utilizing qualitative consensus building methods (Delphi Method) to develop evidence-based recommendations regarding dissemination and implementation of treatment for Veterans.

Interventions

• Behavioral Cognitive Behavioral Therapy (CBT)
  The treatment has three stages. Stage 1 consists of presentation of the CBT model; introduction and discussion of the structure, goals, interventions, and expected outcome of treatment; education regarding binge eating and dieting; and the introduction of self-monitoring techniques for identifying problematic eating practices and triggers. Stage 2 consists of maintaining the normalized eating and self-monitoring procedures but becomes increasingly cognitively oriented. Stage 3 focuses on practic

Primary outcome measures

• Change in binge frequency as assessed by Eating Disorder Examination-Interview 17.0th Edition (EDE). [Time frame: baseline, 3 months (post-treatment), and 6 months]
• Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q) [Time frame: baseline, 3 months (post-treatment), and 6 months]

Secondary outcome measures (4)

• A change in depression score as assessed by the Patient Health Questionnaire-9 (PHQ-9). [Time frame: baseline, 3 months (post-treatment), and 6 months]
• A change in post-traumatic stress disorder (PTSD) as assessed by the PTSD Checklist-5 (PCL-5) with Criterion A. [Time frame: baseline, 3 months (post-treatment), and 6 months]
• Self-assessment of overall wellness as assessed by the Yale Eating and Weight Quality of Life Scale (Yale QoL) and the Visual Analog Scale (VAS) within the European Quality of Life Screener (Euro QoL). [Time frame: baseline, 3 months (post-treatment), and 6 months]
• Participant engagement in treatment and treatment satisfaction as assessed by our own Skills Confidence , Materials Engagement, and Treatment Satisfaction surveys. [Time frame: 3 months (post-treatment)]

Eligibility criteria

Inclusion criteria

• Aged 18 and older
• Presence of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Bulimia Nervosa (BN) or Binge Eating Disorder (BED)
• Veteran Health Administration (VHA) user

Exclusion criteria

• Active psychosis or high acute risk for suicide
• Medical or psychiatric illness, or cognitive deficits, that interfere with providing consent, completing assessments, or engaging in treatment for eating disorders
• Pregnancy or lactation
• Patients with suspected Anorexia or Atypical Anorexia will be excluded and referred to other VA care services

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• VA Connecticut Healthcare System — West Haven

Publications

• Agras WS, Fitzsimmons-Craft EE, Wilfley DE. Evolution of cognitive-behavioral therapy for eating disorders. Behav Res Ther. 2017 Jan;88:26-36. doi: 10.1016/j.brat.2016.09.004. PMID 28110674
• Allison KC, Lundgren JD, O'Reardon JP, Martino NS, Sarwer DB, Wadden TA, Crosby RD, Engel SG, Stunkard AJ. The Night Eating Questionnaire (NEQ): psychometric properties of a measure of severity of the Night Eating Syndrome. Eat Behav. 2008 Jan;9(1):62-72. doi: 10.1016/j.eatbeh.2007.03.007. Epub 2007 Mar 28. PMID 18167324
• American Psychiatric Association. Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing; 2013.
• Arcelus J, Mitchell AJ, Wales J, Nielsen S. Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies. Arch Gen Psychiatry. 2011 Jul;68(7):724-31. doi: 10.1001/archgenpsychiatry.2011.74. PMID 21727255
• Bartlett BA, Mitchell KS. Eating disorders in military and veteran men and women: A systematic review. Int J Eat Disord. 2015 Dec;48(8):1057-69. doi: 10.1002/eat.22454. Epub 2015 Aug 27. PMID 26310193
• Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4. PMID 11438246
• Bellows BK, DuVall SL, Kamauu AW, Supina D, Babcock T, LaFleur J. Healthcare costs and resource utilization of patients with binge-eating disorder and eating disorder not otherwise specified in the Department of Veterans Affairs. Int J Eat Disord. 2015 Dec;48(8):1082-91. doi: 10.1002/eat.22427. Epub 2015 May 8. PMID 25959636
• Bellows BK, LaFleur J, Kamauu AW, Ginter T, Forbush TB, Agbor S, Supina D, Hodgkins P, DuVall SL. Automated identification of patients with a diagnosis of binge eating disorder from narrative electronic health records. J Am Med Inform Assoc. 2014 Feb;21(e1):e163-8. doi: 10.1136/amiajnl-2013-001859. Epub 2013 Nov 7. PMID 24201026

Identifiers

NCT: NCT05304104 · 1645520 · CDMRP-PR203460

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗