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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
No Placebo-Only Group
Summary
This trial tests a new family-involved treatment for young people with eating disorders, delivered by regular doctors. It aims to make effective care more accessible and help parents support their child's recovery.
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.
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.
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mixed methods feedback survey at end of treatment (caregiver/patient)
Rate of recruitment across 3 years
Rate of retention across 3 years
Secondary study objectives
Eating Disorder Symptom Reduction (patient)
Internalized Stigma of Mental Illness Scale (caregiver/patient)
Parent Sense of Competency Scale (caregiver)
+7 moreOther study objectives
Family Questionnaire (caregiver)
Illness Perception Questionnaire (caregiver)
Obsessive-Compulsive Inventory-Revised (patient)
+1 moreAwards & 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: 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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Family-Based Treatment (FBT) involves the family in the treatment process to support the child or adolescent in normalizing their eating patterns and achieving a healthy weight. This approach leverages the family's support system to create a structured environment that encourages healthy eating behaviors and weight restoration.
Cognitive-Behavioral Therapy (CBT) focuses on changing dysfunctional beliefs and behaviors related to body image, eating, and weight. It includes self-monitoring, cognitive restructuring, and behavioral experiments to challenge and modify distorted thoughts and behaviors.
Pharmacotherapy, often using selective serotonin reuptake inhibitors (SSRIs), aims to reduce symptoms of eating disorders by addressing underlying mood and anxiety issues. These treatments are crucial as they address both the psychological and behavioral aspects of eating disorders, providing a comprehensive approach to recovery.
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,936 Previous Clinical Trials
2,751,813 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,806 Total Patients Enrolled
Jocelyn Lebow, PhD, LPPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with an eating disorder that involves limiting my food intake.If my health worsens during the study, I will be reassessed and referred for suitable treatment.
Research Study Groups:
This trial has the following groups:- Group 1: FBT-PC delivered by a primary care provider
- Group 2: Standard FBT
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.