What side effects are associated with this type of intervention?

Family-Based Treatment (FBT) for eating disorders generally has minimal physical side effects, as it primarily involves psychological and behavioral interventions. However, it can be emotionally challenging for both the patient and family members, potentially causing stress and anxiety. Cognitive Behavioral Therapy (CBT) also has few physical side effects but may lead to emotional discomfort as patients confront distressing thoughts and behaviors. Pharmacotherapy, often used as an adjunct, can have side effects depending on the medication, such as gastrointestinal issues, sleep disturbances, and changes in mood or appetite.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for treatments that involve family-based approaches like Family-Based Treatment for Primary Care (FBT-PC) for eating disorders. However, it does highlight the effectiveness of various psychotherapies, such as Cognitive-Behavioral Therapy (CBT), for treating eating disorders. While pharmacotherapy, including the use of SSRIs, has been approved and shown to be effective for conditions like binge eating disorder, family-based treatments remain a cornerstone for addressing eating disorders in children and adolescents, focusing on normalizing eating patterns and achieving a healthy weight with family support.

What other types of research exist?

Promising alternatives to Family-Based Treatment for Primary Care (FBT-PC) for eating disorders include: 1) Cognitive-Behavioral Therapy (CBT), which has shown efficacy in treating anorexia nervosa and bulimia nervosa by addressing dysfunctional beliefs and behaviors related to body image and eating patterns. 2) Specialist Supportive Clinical Management, which combines supportive psychotherapy with clinical management and has shown comparable outcomes to CBT in some studies. 3) The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C), which can be combined with FBT to address coexisting emotional disorders such as anxiety and phobias, as demonstrated in a case report for avoidant/restrictive food intake disorder (ARFID).

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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

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)

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

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 more

Other study objectives

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.

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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

2,869 Previous Clinical Trials

2,777,336 Total Patients Enrolled

61 Trials studying Eating Disorders

24,036 Patients Enrolled for Eating Disorders

Mayo ClinicLead Sponsor

3,298 Previous Clinical Trials

3,958,245 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

~130 spots leftby Oct 2026

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