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

NCT05304104 | Recruiting

• 2 other identifiers: 1645520CDMRP-PR203460
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Change in binge frequency as assessed by Eating Disorder Examination-Interview 17.0th Edition (EDE).

  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)

  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 Outcomes (4)

• A change in depression score as assessed by the Patient Health Questionnaire-9 (PHQ-9).

  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.

  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).

  baseline, 3 months (post-treatment), and 6 months

• Participant engagement in treatment and treatment satisfaction as assessed by our own Skills Confidence , Materials Engagement, and Treatment Satisfaction surveys.

  3 months (post-treatment)

Study Arms (2)

Telehealth Cognitive Behavioral Therapy (teleCBT)

EXPERIMENTAL

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)

Self-Help Cognitive Behavioral Therapy (shCBT)

ACTIVE COMPARATOR

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)

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.

Self-Help Cognitive Behavioral Therapy (shCBT); Telehealth Cognitive Behavioral Therapy (teleCBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Connecticut Healthcare System: lead
• United States Department of Defense: collaborator

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

RECRUITING

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  BACKGROUND

MeSH Terms

Conditions

Binge-Eating Disorder; Bulimia Nervosa

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Robin M Masheb, PhD

  VA Connecticut Research Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin M Masheb, PhD

CONTACT

203-932-5711; Robin.Masheb@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 31, 2022
• Study Start: April 22, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)