Family-Based Treatment for Eating Disorders

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Past FBT, Active suicidality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for children and teens with eating disorders, such as anorexia, characterized by reduced food intake or unexpected weight loss. The treatment, Family-Based Treatment, includes family-based sessions with either a primary care provider or a specialist to support healthier eating habits. The trial aims to determine the feasibility and effectiveness of this approach. Ideal participants are those with restrictive eating disorders who can attend sessions with a caregiver and already have a primary care provider. As an unphased trial, this study provides a unique opportunity to contribute to pioneering research that could shape future treatments for eating disorders.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Family-Based Treatment for Primary Care is safe for children and adolescents with eating disorders?

Research has shown that Family-Based Treatment-Primary Care (FBT-PC) safely treats eating disorders in young people. One study found it effective in primary care settings for teenagers with anorexia nervosa, an eating disorder characterized by weight loss or inadequate weight gain. This indicates that FBT-PC is generally well-tolerated.

This treatment is a version of Family-Based Treatment, widely regarded as the best approach for treating eating disorders in children and teens outside of a hospital. So far, studies have not reported any specific negative effects, suggesting the treatment is generally safe for use in primary care settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family-Based Treatment options for eating disorders because they offer unique delivery methods that could make therapy more accessible. The Family-Based Treatment-Primary Care (FBT-PC) is delivered by a primary care provider in a primary care clinic, making it easier for families to receive treatment without needing to visit a specialized mental health facility. This could make a significant difference for families with limited access to specialized care. Meanwhile, the standard Family-Based Treatment (FBT) is provided by specialist mental health providers, ensuring expert care. These approaches both highlight the importance of family involvement in therapy, which is a key element in addressing eating disorders effectively.

What evidence suggests that this trial's treatments could be effective for eating disorders?

Research has shown that Family-Based Treatment (FBT) effectively treats eating disorders in children and teens, particularly those 18 and younger, often yielding better results than other methods. FBT involves the whole family in the treatment, significantly reducing eating disorder symptoms over time. In this trial, participants will receive either standard FBT, delivered by a specialist mental health provider, or Family-Based Treatment for Primary Care (FBT-PC), delivered by a primary care provider. FBT-PC also shows promise, with more than half of the patients completing treatment successfully. These treatments focus on helping families support their children in overcoming dietary restrictions and weight issues together. ^{1 3 6 7 8}

Who Is on the Research Team?

Jocelyn Lebow, PhD, LP

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Eligible patients will have at least one caregiver who is also willing to participate in the study

Eligible patients must receive primary care through one of 3 MCHS sites connected to the study: Onalaska/La Crosse, Redwing, and Faribault.

I have been diagnosed with an eating disorder that involves limiting my food intake.

Exclusion Criteria

Patients whose enrolled caregiver has active substance dependence, mental health concerns that make it difficult to engage in treatment, or are perpetrators of abuse.

Patients who have received FBT in the past, and/or who report active suicidality

If my health worsens during the study, I will be reassessed and referred for suitable treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 18 sessions of Family-Based Treatment for Primary Care (FBT-PC) or standard FBT over 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Family-Based Treatment
• Family Based Treatment-Primary Care

Trial Overview

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.

How Is the Trial Designed?

Group I: FBT-PC delivered by a primary care provider Experimental Treatment 1 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 FBT Active Control 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Depression is a prevalent issue among adolescents, with psychiatric diagnoses found in 38% of those visiting primary care, making it crucial for physicians to recognize and address this condition.

Cognitive-behavioral therapy (CBT) is an effective treatment for adolescent depression, enhancing skills like self-control and problem-solving, and can be successfully implemented in primary care settings despite initial challenges in teaching the techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helping depressed adolescents: a menu of cognitive-behavioral procedures for primary care. Clabby, JF.[2020]

Family-based treatment (FBT) is the leading recommended intervention for adolescents with eating disorders, but it may not be suitable for all families, particularly if parents are unavailable or unwilling to participate.

Enhanced cognitive behavior therapy (CBT-E) has shown promising results for adolescents aged 11 to 19 and is recommended when FBT is not an option, highlighting the need for further research to compare the effectiveness and acceptability of both treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A conceptual comparison of family-based treatment and enhanced cognitive behavior therapy in the treatment of adolescents with eating disorders. Dalle Grave, R., Eckhardt, S., Calugi, S., et al.[2022]

Family-based treatment (FBT) was found to be significantly more effective than enhanced cognitive-behavior therapy (CBT-E) in promoting weight gain among adolescents with eating disorders, particularly at the end of treatment.

Both FBT and CBT-E showed similar outcomes in terms of eating disorder symptoms and other measures, indicating that CBT-E is also a viable treatment option for adolescents, especially for those who may prefer it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced cognitive-behavior therapy and family-based treatment for adolescents with an eating disorder: a non-randomized effectiveness trial. Le Grange, D., Eckhardt, S., Dalle Grave, R., et al.[2022]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40087916/

Family-Based Treatment for Primary Care

Results: Of the 134 patients who received at least one session of FBT-PC, 55.9% completed treatment, 20.1% were followed until they began a higher level of care ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05814653

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The purpose of this study is to test the feasibility of a RCT of a new treatment for children and adolescents with eating disorders characterized by dietary ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2828763/

Family-Based Treatment for Adolescent Eating Disorders

The only significant finding from this study demonstrated that FBT was particularly efficacious for patients 18 and younger. That is, FBT delivered better ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S1077722923000172

Enhanced Family-Based Treatment for an Adolescent With ...

Empirically supported survey measures were analyzed to monitor treatment outcome. After 21 weeks of treatment, eating disorder symptoms were in remission. In ...

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bmcpsychiatry.biomedcentral.com

bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-025-06672-z

Family-based treatment at home in adolescents with eating ...

Family-based Treatment (FBT) is the standard treatment but has modest remission rates, highlighting the need for improvements. Assessing its ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0891524525001294

Coaching Family-Based Method for Anorexia Nervosa ...

The aim of this study was to describe the experiences of previously healthy adolescents, and their parents regarding anorexia nervosa (AN) outpatient treatment.

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mdpi.com

mdpi.com/2673-5318/5/2/15

Modifications to Enhance Outcomes of Family-Based ...

Eighty percent achieved weight remission by 16 weeks of V-FBT+ and significant changes in both weight and eating disorder cognition/behavior.