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

October 4, 2023 updated by: VA Connecticut Healthcare System

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • Recruiting
        • VA Connecticut Healthcare System
        • Contact:
        • Principal Investigator:
          • Robin Masheb, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telehealth Cognitive Behavioral Therapy (teleCBT)
About 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.
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 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.
Active Comparator: Self-Help Cognitive Behavioral Therapy (shCBT)
About 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).
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
baseline, 3 months (post-treatment), and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months (post-treatment)
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.
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
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.
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
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.
baseline, 3 months (post-treatment), and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Connecticut Healthcare System

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Robin M Masheb, PhD, VA Connecticut Research Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2022

Primary Completion (Estimated)

September 29, 2025

Study Completion (Estimated)

September 29, 2025

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1645520
  • CDMRP-PR203460 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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