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Binge-Eating DisorderEASEDNCT05304104

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

A study testing Cognitive Behavioral Therapy (CBT) in people with Binge-Eating Disorder and Bulimia Nervosa, run by VA Connecticut Healthcare System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cognitive Behavioral Therapy (CBT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
1 siteUnited States
Study dates
22 Apr 2022to 12 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Connecticut Healthcare System

    West Haven, Connecticut, 06516

Other trials in United States

About this study

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

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.

Read the 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.
Being tested
Cognitive Behavioral Therapy (CBT)
Medical subject headings
Binge-Eating Disorder, Bulimia Nervosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Therapy (CBT)Behavioural

    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 practicing skills, consolidation of progress and relapse prevention. Treatment will adhere to a manual developed by Dr. Masheb (PI), adapted for Veterans, and written at a seventh-grade reading level.

Study groups in NCT05304104
Study groupRoleWhat they receive
Telehealth Cognitive Behavioral Therapy (teleCBT)ExperimentalAbout one-half of participants will be randomly assigned to Telehealth Cognitive Behavioral Therapy (teleCBT), a virtual Cognitive Behavioral Therapy (CBT) for binge eating disorders delivered via an Office of Information and Technology (OI\&T)-approved video platform, by a master's-level research clinician. TeleCBT will be administered in 8 to 10 hourly individual sessions over a three-month treatment period.
Receives: Behavioral: Cognitive Behavioral Therapy (CBT)
Self-Help Cognitive Behavioral Therapy (shCBT)Active comparatorAbout one-half of participants will be randomly assigned to Self-Help Cognitive Behavioral Therapy (shCBT), a Self-Help CBT for binge eating disorders initiated by a research assistant via telephone and then continued by the participant at home. These materials are the same exact ones provided to participants in TeleCBT (i.e., treatments are matched for materials), and will be mailed to participants. They will be instructed to work independently through one chapter per week for the following 12 weeks (i.e., treatment length is matched to TeleCBT).
Receives: Behavioral: Cognitive Behavioral Therapy (CBT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in binge frequency as assessed by Eating Disorder Examination-Interview 17.0th Edition (EDE).

    The EDE is the structured diagnostic interview that is considered the gold-standard to diagnose, and assess the symptoms of, eating disorders including binge eating, purging behaviors, and eating disorder pathology.

    Measured: baseline, 3 months (post-treatment), and 6 months

  2. Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)

    The EDE-Q is the self-report version of the more intensive EDE interview. Research has documented that the EDE-Q performs well as a measure of change in treatment trials61and has adequate convergence with the interview format62,63. The EDE-Q generates the same frequency data for eating behaviors (binge eating and overeating) in the past 28 days, and the same four subscales reflecting eating disorder pathology.

    Measured: baseline, 3 months (post-treatment), and 6 months

Secondary outcomes (4)

  1. A change in depression score as assessed by the Patient Health Questionnaire-9 (PHQ-9).

    The PHQ-9 a 9-item self-report questionnaire used to assess for the presence and severity of the symptoms of depression.

    Measured: baseline, 3 months (post-treatment), and 6 months

  2. A change in post-traumatic stress disorder (PTSD) as assessed by the PTSD Checklist-5 (PCL-5) with Criterion A.

    The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Criterion A will be assessed using a standard brief assessment.

    Measured: baseline, 3 months (post-treatment), and 6 months

  3. 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).

    Yale QoL evaluates eight aspects of overall quality of life based specifically on the impact of weight or eating on each domain (physical activity, self-care, daily responsibilities, relationships, public distress, physical discomfort, emotional distress, and shame or guilt). The VAS is used to assess perceived health status ranging from 0 to 100.

    Measured: baseline, 3 months (post-treatment), and 6 months

  4. Participant engagement in treatment and treatment satisfaction as assessed by our own Skills Confidence , Materials Engagement, and Treatment Satisfaction surveys.

    The Skills Confidence survey is a 12-item measure used to determine a participant's level of confidence in a number of skills taught during treatment. Participants can answer on a scale ranging from strongly disagree to strongly agree. The Materials Engagement survey is an 11-item measure used to determine a participant's level of engagement in the materials. The Treatment Satisfaction survey is an 11-item measure that is used to determine how helpful a number of skills were to manage a participant's binge eating behaviors on a scale from 0 to 4.

    Measured: 3 months (post-treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start22 Apr 2022
  3. Primary completion13 Mar 2025
  4. Study completion12 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05304104
Sponsor's protocol ID
1645520
Other IDs
CDMRP-PR203460
Acronym
EASED
Status last verified
Nov 2025
First submitted
18 Feb 2022
Last updated
9 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 24201026

  • Daeppen JB, Yersin B, Landry U, Pecoud A, Decrey H. Reliability and validity of the Alcohol Use Disorders Identification Test (AUDIT) imbedded within a general health risk screening questionnaire: results of a survey in 332 primary care patients. Alcohol Clin Exp Res. 2000 May;24(5):659-65.

    PubMed 10832907

  • Economic Research Service, USDA. U.S. Household Food Security Survey Module: Six-Item Short Form. 2012.

  • Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.

    PubMed 7866415

  • Fairburn C, Cooper Z, O'Connor M. Eating disorder examination: Edition 17.0D. 2014.

  • Fairburn, C. G. & cooper, Z. The eating disorder examination. in Fairburn, C. G., Wilson, G. T., & Schleimer, K. (1993). Binge eating: Nature, assessment, and treatment (pp. 317-360). New York: Guilford Press.

  • Fairburn C. Overcoming binge eating. Guilford Press; 1995.

  • Foa EB, Riggs DS, Dancu CV, Rothbaum BO. Reliability and validity of a brief instrument for assessing post-traumatic stress disorder. J Traum Stress. 1993;6(4):459-473. https://doi.org/10.1002/jts.2490060405. doi: https://doi.org/10.1002/jts.2490060405.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy (CBT) in people with Binge-Eating Disorder and Bulimia Nervosa, run by VA Connecticut Healthcare System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05304104, which also lists 57 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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