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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Family-Based Treatment for Eating Disorders?

Family-based approaches, like those used in depression case management, have shown positive impacts on self-management and symptom improvement, suggesting that involving family in treatment can be beneficial. Additionally, cognitive-behavioral therapy, which shares some principles with family-based treatments, has been effective in treating adolescent depression, indicating potential benefits for other conditions. ^{1 2 3 4 5}

Is Family-Based Treatment for Eating Disorders safe for humans?

Family-Based Treatment (FBT) is widely used for adolescents with eating disorders and is considered safe, as it involves family support and engagement in the treatment process. There is no specific mention of safety concerns in the research, suggesting it is generally safe for human use. ^{6 7 8 9 10}

How is Family-Based Treatment for Primary Care (FBT-PC) different from other treatments for eating disorders?

Family-Based Treatment for Primary Care (FBT-PC) is unique because it adapts the traditional Family-Based Treatment (FBT) to be delivered by primary care providers, making it more accessible for adolescents with restrictive eating disorders. This approach helps overcome the scarcity of specialized providers and allows for treatment within a primary care setting, potentially improving access and outcomes. ^{6 7 8 10 11}

Research Team

Jocelyn Lebow, PhD, LP

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

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.

Exclusion Criteria

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.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Follow-up. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Deteriorated and unchanged patients in psychological treatment in Swedish primary care and psychiatry. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Duration of psychological therapy: relation to recovery and improvement rates in UK routine practice. [corrected]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Positive impact of a family practice-based depression case management on patient's self-management. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Can adolescents with eating disorders be treated in primary care? A retrospective clinical cohort study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Family-based intervention in adolescent restrictive eating disorders: early treatment response and low weight suppression is associated with favourable one-year outcome. [2018]

8. England 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Family-based Treatment of Eating Disorders: A Narrative Review. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Enhanced cognitive-behavior therapy and family-based treatment for adolescents with an eating disorder: a non-randomized effectiveness trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

A primary care modification of family-based treatment for adolescent restrictive eating disorders. [2021]