Clinical trial NCT05304104: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Binge-Eating Disorder
Bulimia Nervosa
Veterans Health
Cognitive Behavioral Therapy
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
Collaborators: name: United States Department of Defense
First posted: 2022-03-31
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Change in binge frequency as assessed by Eating Disorder Examination-Interview 17.0th Edition (EDE).
timeFrame: baseline, 3 months (post-treatment), and 6 months
measure: Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)
timeFrame: baseline, 3 months (post-treatment), and 6 months
Secondary outcomes:
measure: A change in depression score as assessed by the Patient Health Questionnaire-9 (PHQ-9).
timeFrame: baseline, 3 months (post-treatment), and 6 months
measure: A change in post-traumatic stress disorder (PTSD) as assessed by the PTSD Checklist-5 (PCL-5) with Criterion A.
timeFrame: baseline, 3 months (post-treatment), and 6 months
measure: 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).
timeFrame: baseline, 3 months (post-treatment), and 6 months
measure: Participant engagement in treatment and treatment satisfaction as assessed by our own Skills Confidence , Materials Engagement, and Treatment Satisfaction surveys.
timeFrame: 3 months (post-treatment)
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Research Department
name: Robin M Masheb, PhD
role: PRINCIPAL_INVESTIGATOR
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