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

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
VA Connecticut Healthcare System
Study ID
NCT05304104
Status
Recruiting
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Conditions

  • Binge-Eating Disorder
  • Bulimia Nervosa
  • Cognitive Behavioral Therapy
  • Veterans Health

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Apr 22, 2022
Status verified
Nov 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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).

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Connecticut Healthcare SystemWest HavenConnecticut06516
Robin Masheb, PhD
[email protected]
203-932-5711
Robin Masheb, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
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