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Family-Based Treatment for Eating Disorders

N/A

Waitlist Available

Led By Jocelyn Lebow, PhD, LP

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up rate of retention at end of study (3 years)

Awards & highlights

Study Summary

This trial tests a new treatment to help children/teens with eating disorders characterized by dietary restriction/weight loss. Called FBT-PC, it's based on the gold standard treatment for this age group.

Who is the study for?

This trial is for children and adolescents with eating disorders like anorexia nervosa, who haven't had Family-Based Treatment before. They need a caregiver to join the study with them and must get care from specific MCHS sites. Those with past FBT, active suicidal thoughts, unstable conditions, or caregivers with substance dependence or mental health issues that hinder treatment engagement are excluded.Check my eligibility

What is being tested?

The study tests a new treatment called Family-Based Treatment for Primary Care (FBT-PC), derived from the standard outpatient therapy for young people's eating disorders. It aims to see if this approach works well when applied in primary care settings.See study design

What are the potential side effects?

Since this trial involves psychological therapy rather than medication, side effects may include emotional distress or discomfort during sessions. However, physical side effects typically associated with medications are not expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ rate of retention at end of study (3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~rate of retention at end of study (3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and rate of retention at end of study (3 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mixed methods feedback survey at end of treatment (caregiver/patient)

Rate of recruitment across 3 years

Rate of retention across 3 years

Secondary outcome measures

Eating Disorder Symptom Reduction (patient)

Internalized Stigma of Mental Illness Scale (caregiver/patient)

Parent Sense of Competency Scale (caregiver)

+7 more

Other outcome measures

Family Questionnaire (caregiver)

Illness Perception Questionnaire (caregiver)

Obsessive-Compulsive Inventory-Revised (patient)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FBT-PC delivered by a primary care providerExperimental Treatment1 Intervention

Subjects will receive up to 18 sessions of FBT-PC, delivered by a primary care provider, at their primary care clinic over 6 months.

Group II: Standard FBTActive Control1 Intervention

Subjects will receive up to 18 session of FBT, delivered by a specialist mental health provider at Mayo Clinic in Rochester, MN over 6 months.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,789 Previous Clinical Trials

2,690,230 Total Patients Enrolled

61 Trials studying Eating Disorders

24,960 Patients Enrolled for Eating Disorders

Mayo ClinicLead Sponsor

3,227 Previous Clinical Trials

3,771,468 Total Patients Enrolled

1 Trials studying Eating Disorders

17 Patients Enrolled for Eating Disorders

Jocelyn Lebow, PhD, LPPrincipal InvestigatorMayo Clinic

Media Library

Family-Based Treatment Clinical Trial Eligibility Overview. Trial Name: NCT05814653 — N/A

Eating Disorders Research Study Groups: FBT-PC delivered by a primary care provider, Standard FBT

Eating Disorders Clinical Trial 2023: Family-Based Treatment Highlights & Side Effects. Trial Name: NCT05814653 — N/A

Family-Based Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05814653 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accommodate participants aged 25 or above?

"According to the guidelines for this medical trial, eligible participants must be between 7 and 18 years of age."

Answered by AI

Is it possible for me to be a contributor in this medical experiment?

"The parameters for eligibility in this study necessitate that applicants have eating disorders and are between 7 to 18 years old. Currently, the team is recruiting approximately 200 participants."

Answered by AI

Is this experiment in need of more participants?

"As indicated on clinicaltrials.gov, the recruitment phase for this medical trial has already concluded; it was initially posted in April 15th 2023 and last updated on April 3rd 2023. Fortunately, there are still 101 other trials that are actively looking for participants."

Answered by AI

What is this trial ultimately attempting to achieve?

"This medical trial aspires to evaluate its efficacy over a three-year period. The primary outcomes are measured through the Parent Sense of Competency Scale (caregiver), Eating disorder Symptom Reduction (patient) and Internalized Stigma of Mental Illness Scale (caregiver/patient). Respectively, these scores range from 17-102, 0-6 and 29-116 with higher numbers indicating more confidence in parenting competencies or greater severity in eating disorder symptomology."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Primary Care Treatment for Adolescent Eating Disorders

Jocelyn R. Lebow 2023. "A Study to Evaluate Primary Care Treatment for Adolescent Eating Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05814653.

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