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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months (post-treatment), and 6 months
Awards & highlights
EASED Trial 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.Check my eligibility
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.See study design
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.
EASED Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Bulimia Nervosa or Binge Eating Disorder.
EASED Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreSide effects data
From 2018 Phase 4 trial • 95 Patients • NCT0104127418%
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%
Sleep disturbed
2%
Anorgasmia
2%
Blurred vision
2%
Dizziness upon standing
2%
Drug abuse
2%
Akathisia
2%
Drooling
2%
Appetite decrease
2%
Drug-related hospitalization
2%
Apathy
2%
Cellulitis
2%
Hot flashes
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
EASED 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
81 Previous Clinical Trials
6,566 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,050 Total Patients Enrolled
1 Trials studying Bulimia
129 Patients Enrolled for Bulimia
Robin M Masheb, PhDPrincipal InvestigatorVA Connecticut Research Department
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I do not have anorexia or atypical anorexia.I have been diagnosed with Bulimia Nervosa or Binge Eating Disorder.You have a mental health condition that makes you at risk for severe emotional distress or self-harm.
Research Study Groups:
This trial has the following groups:- Group 1: Telehealth Cognitive Behavioral Therapy (teleCBT)
- Group 2: Self-Help Cognitive Behavioral Therapy (shCBT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the ceiling of participants in this research endeavor?
"Affirmative. The information posted on clinicaltrials.gov indicates that the trial is currently accepting volunteers; it was first listed on April 22nd 2022 and recently updated on August 10th 2022, with a goal of recruiting 144 patients from one particular site."
Answered by AI
Are there any openings for participation in this investigation?
"Yes, the information on clinicaltrials.gov affirms that this trial is actively recruiting patients. The study was announced on April 22nd 2022 and has since been revised for accuracy; it seeks to enroll 144 individuals from one medical centre."
Answered by AI
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