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Behavioral Intervention

Cognitive Behavioral Therapy for Eating Disorders (EASED Trial)

N/A

Recruiting

Led By Robin M Masheb, PhD

Research Sponsored by VA Connecticut Healthcare System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Bulimia Nervosa (BN) or Binge Eating Disorder (BED)

Be older than 18 years old

Must not have

Patients with suspected Anorexia or Atypical Anorexia will be excluded and referred to other VA care services

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new, state of the art treatment for eating disorders that can be done virtually, making it more accessible to those who need it. The goal is to improve clinical outcomes and make a real-world impact among diverse and underrepresented eating disorder populations.

Who is the study for?

This trial is for adults over 18 who are part of the Veteran Health Administration and have been diagnosed with Bulimia Nervosa or Binge Eating Disorder. It's not for those with Anorexia, pregnant or nursing individuals, or anyone with medical/psychiatric conditions that could hinder participation.

What is being tested?

The study tests Cognitive Behavioral Therapy (CBT) delivered virtually to treat eating disorders in veterans and underrepresented groups. The goal is to integrate this treatment into VA telehealth services and improve clinical outcomes.

What are the potential side effects?

Since CBT is a non-medical therapy involving talking and behavior change strategies, it typically doesn't cause physical side effects. However, some may experience emotional discomfort discussing sensitive topics during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Bulimia Nervosa or Binge Eating Disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have anorexia or atypical anorexia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months (post-treatment), and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months (post-treatment), and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months (post-treatment), and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)

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

Secondary study objectives

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

A change in post-traumatic stress disorder (PTSD) as assessed by the PTSD Checklist-5 (PCL-5) with Criterion A.

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

+1 more

Side effects data

From 2018 Phase 4 trial • 95 Patients • NCT01041274

18%

Weight increase

10%

Tachycardia

Psychiatric Hospitalization

Hypertension

Loss of libido

Appetite increase

Concentration impaired

Memory impaired

Rash

Restlessness

Amenorrhea

Cellulitis

Appetite decrease

Hot flashes

Apathy

Akathisia

Anorgasmia

Drug-related hospitalization

Drug abuse

Blurred vision

Drooling

Dizziness upon standing

Sleep disturbed

Medical Hospitalization

Fatigue

Hiccup

Hit by a motorcycle

Hurt when riding a bike

Mental activity decreased

Muscle twitch

Sleeplessness

Pneumonia

Nightmares

Teeth grating

Incarceration

Sensory hallucinations

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Citalopram

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Telehealth Cognitive Behavioral Therapy (teleCBT)Experimental Treatment1 Intervention

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.

Group II: Self-Help Cognitive Behavioral Therapy (shCBT)Active Control1 Intervention

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavioral Therapy (CBT)

2008

Completed Phase 4

~3620

0 / 2Eligibility criteria met