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NCT Number: NCT05304104

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

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.

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Key information

Conditions

Binge-Eating Disorder Bulimia Nervosa Cognitive Behavioral Therapy Feeding and Eating Disorders Mental Disorders Veterans Health

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location status: Recruiting

Location contact

Robin Masheb, PhD

CONTACT

[email protected]

203-932-5711 ext. 3954

Robin Masheb, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

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.

Primary outcomes

  1. 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 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.

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

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

    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.

Secondary outcomes

  1. 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

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

  2. 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

    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.

  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).

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

    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.

  4. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Robin M Masheb, PhD

CONTACT

[email protected]

203-932-5711 ext. 3954

Sponsors and collaborators

Lead sponsor

VA Connecticut Healthcare System

Fed

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Acronym: EASED

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2022
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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