Facing Eating Disorder Fears for Anorexia Nervosa

(FED-F Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Cheri A Levinson, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Louisville

Stay on Your Current Meds

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests a therapy called FED-F that helps people with Anorexia Nervosa face their fears about food, weight, and social situations. The goal is to see if this approach can reduce anxiety and prevent relapse by encouraging patients to confront their fears.

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.

What data supports the idea that Facing Eating Disorder Fears for Anorexia Nervosa is an effective treatment?

The available research shows that addressing fears related to eating disorders, such as fear of food and weight gain, is crucial for preventing relapse after intensive treatment. One study highlights that fear of food can predict a drive for thinness, a core symptom of eating disorders, suggesting that targeting these fears can help reduce symptoms. Another study suggests that imaginal exposure therapy, which involves confronting these fears, may be more effective in preventing readmission than other interventions. This indicates that Facing Eating Disorder Fears for Anorexia Nervosa could be an effective treatment by directly addressing the fears that contribute to the disorder. ^{1 2 3 4 5}

What safety data exists for Facing Eating Disorder Fears treatment for Anorexia Nervosa?

The provided research does not directly address safety data for the Facing Eating Disorder Fears treatment for Anorexia Nervosa. However, it discusses the role of fear and anxiety in eating disorders and the potential of exposure therapy to address these fears. The pilot randomized control trial mentioned aims to test the feasibility and acceptability of an online imaginal exposure therapy, which could inform safety and efficacy in the future. Currently, there is no specific safety data available for this treatment. ^{1 2 3 6 7}

Is the treatment Facing Eating Disorder Fears Condition a promising treatment for anorexia nervosa?

Yes, Facing Eating Disorder Fears Condition is a promising treatment for anorexia nervosa because it targets the core fears that maintain the disorder, such as fear of weight gain and social consequences. By addressing these fears, the treatment helps reduce anxiety and disordered eating behaviors, making it a valuable approach for those struggling with anorexia nervosa. ^{1 3 7 8 9}

Research Team

Cheri A Levinson, Ph.D.

Principal Investigator

University of Louisville

Eligibility Criteria

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 am between 18 and 65 years old.

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.

Treatment Details

Interventions

• Facing Eating Disorder Fears Condition (Behavioral Intervention)

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.

Participant Groups

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.

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+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Findings from Research

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]

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]

References

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

Core eating disorder fears: Prevalence and differences in eating disorder fears across eating disorder diagnoses. [2022]

2. United States 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. [2023]

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

Anxiety disorders in anorexia nervosa and bulimia nervosa: co-morbidity and chronology of appearance. [2022]

4. England 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. [2021]

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

Fear of food prospectively predicts drive for thinness in an eating disorder sample recently discharged from intensive treatment. [2018]

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

Fear as a translational mechanism in the psychopathology of anorexia nervosa. [2019]

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

Development and validation of the eating disorder fear questionnaire and interview: Preliminary investigation of eating disorder fears. [2020]

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

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

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

Imaginal Exposure for Disordered Eating Related Fears: An Initial Randomized Controlled Trial. [2022]