Facing Eating Disorder Fears for Anorexia Nervosa

(FED-F Trial)

Overseen By Cheri A Levinson, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Disqualifiers: Suicidality, Mania, Psychosis, Low weight, others

Stay on Your Current Meds You can continue your current medications while participating

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called FED-F, designed to help people with anorexia nervosa confront fears related to food, body image, and social situations. The researchers aim to determine if FED-F is more effective than standard care after a patient leaves intensive treatment. Participants will try this treatment virtually to assess its impact on recovery and relapse prevention. Suitable candidates have recently been discharged from an intensive treatment program and have a history of anorexia nervosa or a similar condition. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance recovery strategies for anorexia nervosa.

Do I have to stop taking my current medications for this trial?

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

Do I need to stop my current medications for this trial?

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 healthcare provider.

What prior data suggests that the Facing Eating Disorder Fears Condition is safe for treating anorexia nervosa?

Research shows that exposure therapy, a component of the Facing Eating Disorder Fears (FED-F) treatment, can be safe for patients. Previous studies have helped people confront their fears and reduce anxiety. For eating disorders, exposure therapy often involves gradually facing fears related to food and body image.

A review of studies found that many patients handle exposure therapy well, and it can lead to less dissatisfaction with their bodies when combined with cognitive-behavioral therapy (CBT). This suggests that FED-F, which combines exposure therapy with education about the disorder and cognitive skills, may also be well-received.

No specific negative effects have been reported for FED-F, likely because it focuses on psychological methods rather than medication. However, since this is a new approach specifically for anorexia nervosa, ongoing studies will continue to assess its safety and effectiveness.

Overall, evidence suggests that FED-F could be a safe option for those looking to address fears associated with anorexia nervosa. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Facing Eating Disorder Fears Condition" trial because it offers a fresh approach to treating anorexia nervosa. Unlike standard treatments that often rely on in-person therapy and nutritional counseling, this method incorporates virtual treatment sessions, making it more accessible and flexible for participants. Additionally, the integration of mobile assessments allows for real-time tracking of progress and personalization of care, which could lead to more effective and timely interventions. This innovative approach has the potential to make treatment more engaging and responsive to individual needs.

What evidence suggests that the FED-F treatment could be effective for anorexia nervosa?

Research has shown that the Facing Eating Disorder Fears treatment (FED-F), which participants in this trial may receive, helps people with anorexia nervosa by reducing their fears and avoidance behaviors. This method combines exposure therapy with education and cognitive skills to address fears about food, weight gain, and social situations. Early results suggest that targeting these primary fears can lead to better outcomes for those with eating disorders. Studies indicate that reducing these fears may improve eating habits and decrease the chances of relapse. This treatment is designed as an accessible online option for those seeking help with anorexia nervosa. ^{1 2 4 6 7}

Who Is on the Research Team?

Cheri A Levinson, Ph.D.

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who have been diagnosed with Anorexia Nervosa (AN) or are in partial/full remission from AN, and have been discharged from intensive care like inpatient or residential treatment within the last 6 months. It's not suitable for individuals under 18, over 65, those with severe suicidal thoughts, extremely low weight, psychosis, mania, or who don't meet the criteria for AN.

Inclusion Criteria

I have been diagnosed with anorexia or atypical anorexia, including any stage of remission.

I was discharged from a hospital or intensive care unit less than 6 months ago.

Exclusion Criteria

I do not have anorexia or am not in remission from it.

Active psychosis

I am over 65 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I: Refinement and Feasibility Testing

Refine FED-F into a fully virtual format with input from patients and stakeholders and collect preliminary data on its feasibility and acceptability

Not specified

1 session of education, followed by sessions 2 through 12 of virtual treatment

Phase II: Pilot RCT

Conduct a small pilot RCT of FED-F as compared to treatment as usual (TAU)

Up to 12 sessions

Virtual treatment sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

What Are the Treatments Tested in This Trial?

Interventions

• Facing Eating Disorder Fears Condition

Trial Overview

The study tests a virtual treatment called FED-F that combines exposure therapy with education and cognitive skills to help patients face fears related to food, weight gain, body perception, and social situations. The goal is to see if it's more effective than usual treatments after acute care and if it improves approach behaviors associated with relapse.

How Is the Trial Designed?

Group I: Facing Eating Disorder Fears Condition Experimental Treatment 1 Intervention

Participants will complete 1 session of education about the treatment. After completion of treatment education and baseline questionnaires, participants will complete sessions 2 through 12 of virtual treatment for anorexia nervosa and mobile assessments.

Group II: Treatment as Usual Active Control 1 Intervention

Participants will complete baseline measures, mobile assessments and treatment as usual.

Facing Eating Disorder Fears Condition is already approved in United States for the following indications:

Approved in United States as FED-F for:

• Anorexia Nervosa

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study of 229 individuals with eating disorders, the most commonly reported fears were fear of gaining weight, fear of food, and fear of judgment, indicating that these fears play a significant role in maintaining eating disorder behaviors.

The research found that while there were some differences in fears based on eating disorder diagnosis and weight status, the overall heterogeneity of fears suggests that personalized assessment and treatment approaches are crucial for effective intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Core eating disorder fears: Prevalence and differences in eating disorder fears across eating disorder diagnoses. Brown, ML., Levinson, CA.[2022]

Imaginal exposure therapy was found to be more acceptable to participants than imaginal exposure combined with food exposure, suggesting a preference for targeting fears directly without the added stress of food exposure.

While all treatment conditions led to a decrease in disordered eating symptoms and fears, the study indicates that the improvements were not solely due to imaginal exposure, highlighting the need for further research to understand the mechanisms of change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaginal Exposure for Disordered Eating Related Fears: An Initial Randomized Controlled Trial. Butler, RM., Heimberg, RG.[2022]

Anorexia nervosa (AN) is a serious psychiatric disorder characterized by intense fear of weight gain and body scrutiny, with current treatments showing only modest success.

Investigating the role of fear-related learning and the inability to recognize safety cues may help uncover the underlying mechanisms of AN, potentially leading to more effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fear as a translational mechanism in the psychopathology of anorexia nervosa. Murray, SB., Strober, M., Craske, MG., et al.[2019]

In a study of 63 patients with anorexia nervosa (AN) or bulimia nervosa (BN), a high prevalence of anxiety disorders was found, with 83% of AN patients and 71% of BN patients having at least one lifetime anxiety disorder, most commonly social phobia.

The majority of patients (75% of AN and 88% of BN) had their anxiety disorder develop before the onset of their eating disorder, highlighting the importance of addressing anxiety in the treatment of eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety disorders in anorexia nervosa and bulimia nervosa: co-morbidity and chronology of appearance. Godart, NT., Flament, MF., Lecrubier, Y., et al.[2022]

Over 50% of individuals with eating disorders are likely to be readmitted to treatment within 6 months due to ongoing cognitive issues related to their disorder, highlighting the need for effective post-treatment interventions.

This pilot randomized control trial will assess the effectiveness of a five-session online imaginal exposure therapy in reducing eating disorder symptoms and fears, compared to a control writing intervention, aiming to prevent readmission and improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized control trial of online exposure for eating disorders and mechanisms of change delivered after discharge from intensive eating disorder care: A registered report. Levinson, CA., Ralph-Nearman, C., Brown, ML., et al.[2023]

Patients with anorexia nervosa often experience an intense fear of being fat, which can persist even after they regain normal weight and resume menstruation, indicating a complex relationship between body image and psychological factors.

The fear of being fat is not exclusive to anorexic individuals; it is also observed in nonanorexic women and some men, suggesting that societal and psychological influences contribute to body image disturbances across different populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The fear of being fat and anorexia nervosa. Wilson, CP.[2006]

In a study of 168 individuals with eating disorders, fears related to food, particularly anxiety about eating, were found to predict an increase in drive for thinness, a key symptom of these disorders, one month after intensive treatment.

The findings suggest that addressing fears of food in treatment could be crucial for reducing the drive for thinness and potentially preventing relapse in individuals recovering from eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fear of food prospectively predicts drive for thinness in an eating disorder sample recently discharged from intensive treatment. Levinson, CA., Brosof, LC., Ma, J., et al.[2018]

A study involving 64 participants (35 with anorexia nervosa and 29 healthy controls) used implicit association tests to measure the implicit drive for thinness, revealing that individuals with anorexia have a stronger implicit fear of weight gain compared to healthy individuals.

The findings suggest that fear of weight gain should be viewed as a continuous construct, which could lead to more personalized treatment approaches for those with anorexia nervosa, as it captures varying degrees of this fear beyond self-reported measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming limitations of self-report: an assessment of fear of weight gain in anorexia nervosa and healthy controls using implicit association tests. Borgers, T., Krüger, N., Vocks, S., et al.[2021]

The study developed two reliable measures to assess specific fears related to eating disorders: the Eating Disorder Fear Questionnaire (EFQ) and the Eating Disorder Fear Interview (EFI), tested on 642 participants (513 undergraduates and 129 clinical ED patients).

Both measures revealed that fears associated with eating disorders are complex and varied, highlighting the need for personalized treatment approaches that address these specific fears.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of the eating disorder fear questionnaire and interview: Preliminary investigation of eating disorder fears. Levinson, CA., Vanzhula, IA., Christian, C.[2020]

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