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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

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 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
6%
Psychiatric Hospitalization
6%
Hypertension
6%
Loss of libido
4%
Concentration impaired
4%
Appetite increase
4%
Memory impaired
4%
Rash
4%
Restlessness
4%
Amenorrhea
2%
Cellulitis
2%
Dizziness upon standing
2%
Drug abuse
2%
Hot flashes
2%
Blurred vision
2%
Drooling
2%
Drug-related hospitalization
2%
Akathisia
2%
Anorgasmia
2%
Apathy
2%
Appetite decrease
2%
Sleep disturbed
2%
Medical Hospitalization
2%
Fatigue
2%
Hiccup
2%
Hit by a motorcycle
2%
Hurt when riding a bike
2%
Mental activity decreased
2%
Muscle twitch
2%
Sleeplessness
2%
Pneumonia
2%
Nightmares
2%
Teeth grating
2%
Incarceration
2%
Sensory hallucinations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Citalopram

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

Find a Location

Who is running the clinical trial?

VA Connecticut Healthcare SystemLead Sponsor
84 Previous Clinical Trials
8,386 Total Patients Enrolled
United States Department of DefenseFED
891 Previous Clinical Trials
332,334 Total Patients Enrolled
1 Trials studying Bulimia
129 Patients Enrolled for Bulimia
Robin M Masheb, PhDPrincipal InvestigatorVA Connecticut Research Department
1 Previous Clinical Trials
109 Total Patients Enrolled
1 Trials studying Bulimia
109 Patients Enrolled for Bulimia

Media Library

Cognitive Behavioral Therapy (CBT) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05304104 — N/A
Bulimia Research Study Groups: Telehealth Cognitive Behavioral Therapy (teleCBT), Self-Help Cognitive Behavioral Therapy (shCBT)
Bulimia Clinical Trial 2023: Cognitive Behavioral Therapy (CBT) Highlights & Side Effects. Trial Name: NCT05304104 — N/A
Cognitive Behavioral Therapy (CBT) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05304104 — N/A
~42 spots leftby Sep 2025
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