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

Sponsor

VA Connecticut Healthcare System (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT05304104

Collaborator

United States Department of Defense (U.S. Fed)

144

Enrollment

Location

Arms

41.3

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Binge-Eating Disorder Bulimia Nervosa Veterans Health Cognitive Behavioral Therapy	Behavioral: Cognitive Behavioral Therapy (CBT)	N/A

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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 22, 2022

Anticipated Primary Completion Date :

Sep 29, 2025

Anticipated Study Completion Date :

Sep 29, 2025

Arms and Interventions

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.

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)

Outcome Measures

Primary Outcome Measures

Change in binge frequency as assessed by Eating Disorder Examination-Interview 17.0th Edition (EDE). [baseline, 3 months (post-treatment), 6 months, and 12 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.

Secondary Outcome Measures

A change in depression score as assessed by the Patient Health Questionnaire-9 (PHQ-9). [baseline, 3 months (post-treatment), 6 months, and 12 months]
The PHQ-9 a 9-item self-report questionnaire used to assess for the presence and severity of the symptoms of depression.
A change in post-traumatic stress disorder (PTSD) as assessed by the PTSD Checklist-5 (PCL-5) with Criterion A. [baseline, 3 months (post-treatment), 6 months, and 12 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.
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). [baseline, 3 months (post-treatment), 6 months, and 12 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.
Participant engagement in treatment and treatment satisfaction as assessed by our own Skills Confidence , Materials Engagement, and Treatment Satisfaction surveys. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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