Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT05304104
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2022-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Building an Equitable and Accessible System of Eating Disorder Care for VA, DoD, and Underrepresented Americans
Sponsor:
VA Connecticut Healthcare System
Organization:
Study Overview
Official Title:
Building an Equitable and Accessible System of Eating Disorder Care for VA, DoD, and Underrepresented Americans With Eating Disorders (EASED Study)
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EASED
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.
* 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CDMRP-PR203460 | OTHER_GRANT | Department of Defense | View |