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Behavioral Intervention
Cognitive Behavioral Therapy for ARFID
N/A
Recruiting
Led By Helen Burton Murray, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study completion, an average of 3 years
Awards & highlights
Study Summary
This trial tested a therapy to help adults with digestive issues and difficulty eating, due to ARFID, to gain weight.
Who is the study for?
This trial is for adults with functional dyspepsia and ARFID, who've lost weight since the onset of FD. They must be stable enough for outpatient care, have not had CBT for FD or ARFID before, can use a computer with webcam, haven't changed medications recently, speak English fluently, and don’t have certain medical conditions like psychosis or recent surgeries.Check my eligibility
What is being tested?
The study tests an exposure-based cognitive behavioral therapy (CBT) specifically designed to treat avoidant/restrictive food intake in individuals suffering from functional dyspepsia. Participants are randomly assigned to receive this treatment to see if it helps improve their condition.See study design
What are the potential side effects?
Since the intervention involves therapy rather than medication, typical drug side effects aren't expected. However, participants may experience emotional discomfort or increased anxiety as they confront avoided foods during the treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout study completion, an average of 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study completion, an average of 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment completion
Client Satisfaction
Enrollment
+2 moreSecondary outcome measures
Dyspepsia
Side effects data
From 2021 Phase 4 trial • 12 Patients • NCT041359378%
irritability
100%
80%
60%
40%
20%
0%
Study treatment Arm
MESH
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Behavioral TherapyExperimental Treatment1 Intervention
Subjects will receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder.
Group II: Usual CareActive Control1 Intervention
In the usual care condition, participants will be allowed to continue with treatment they are already receiving at the time of randomization, and we will collect detailed data on the nature of these interventions. Participants will be allowed to pursue non study treatments in this condition.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy
2016
Completed Phase 4
~3120
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,431 Total Patients Enrolled
6 Trials studying Eating Disorders
575 Patients Enrolled for Eating Disorders
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,542 Total Patients Enrolled
5 Trials studying Eating Disorders
3,356 Patients Enrolled for Eating Disorders
Helen Burton Murray, PhDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have a history of a serious medical condition.I have been diagnosed with a type of indigestion that gets worse after eating.My medication dose has been the same for the last 30 days.I have been diagnosed with ARFID.I have had surgery on my stomach or intestines.I am stable enough to be cared for outside of a hospital.I have never had cognitive behavioral therapy for stomach issues or eating disorders.I have lost more than 5% of my weight since my stomach issues started.I do not have any other health conditions that could explain my symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Behavioral Therapy
- Group 2: Usual Care
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.
Is there currently an enrollment period for this research endeavor?
"Data from clinicaltrials.gov confirms that this medical trial is actively enrolling patients and has been open since November 30th 2022, with the most recent posting being on the same date."
Answered by AI
How many participants are enrolled in this investigation?
"Affirmative. Clinicaltrials.gov information reveals that this study is still recruiting participants; the original post date was November 30th 2022 and it has been revised as recently as the same day. Accordingly, 50 patients need to be sourced from one medical facility."
Answered by AI
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