What is the mechanism of action of this treatment?

The most common treatments for Anorexia Nervosa, such as FED-F, CBT, and FBT, work by addressing the core fears and maladaptive behaviors associated with the disorder. FED-F enhances exposure therapy with psychoeducation and cognitive skills to help patients face their fears of food, weight gain, and social situations, thereby promoting approach behaviors. This is crucial for Anorexia Nervosa patients as it helps them gradually confront and overcome their anxieties, leading to healthier eating patterns and improved psychological well-being. These treatments aim to modify the underlying cognitive distortions and behavioral patterns, facilitating long-term recovery and reducing the risk of relapse.

What side effects are associated with this type of intervention?

Common treatments for Anorexia Nervosa, such as cognitive-behavioral therapy (CBT) and exposure therapy, generally have minimal physical side effects but can cause emotional distress as patients confront their fears and anxieties. Psychoeducation and cognitive skills training, as used in FED-F, may lead to temporary increases in anxiety or stress as patients work through challenging material. However, these effects are typically short-lived and manageable with proper therapeutic support. Overall, these treatments are considered safe and effective, with the primary side effects being related to the emotional and psychological challenges inherent in the therapeutic process.

What prior FDA approvals exist?

Currently, there are no FDA-approved medications specifically for the treatment of Anorexia Nervosa. Treatment approaches often include psychological therapies such as Cognitive Behavioral Therapy (CBT) and family-based therapy. The FED-F trial is exploring a novel approach by enhancing exposure therapy with psychoeducation and cognitive skills to target approach behaviors, which is a different strategy compared to traditional treatments. While medications like fluoxetine and olanzapine have been used off-label to support weight gain and manage comorbid conditions, they are not FDA-approved for Anorexia Nervosa.

What other types of research exist?

Promising alternatives to FED-F for Anorexia Nervosa treatment in 2024 include: 1) Enhanced Cognitive Behavioral Therapy (CBT-E), which has shown efficacy in treating eating disorders by addressing cognitive distortions and maladaptive behaviors. 2) Family-Based Treatment (FBT), particularly effective for adolescents, involving family members in the recovery process. 3) Integrative approaches combining CBT with nutritional counseling and medical management to address both psychological and physical aspects of AN. 4) Emerging pharmacological treatments, such as low-dose atypical antipsychotics (e.g., olanzapine), which may help with weight gain and reducing anxiety related to eating. These alternatives offer comprehensive and multi-faceted approaches to treating AN.

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Facing Eating Disorder Fears for Anorexia Nervosa (FED-F Trial)

N/A

Recruiting

Led By Cheri A Levinson, Ph.D.

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2-month follow-up

Awards & highlights

FED-F Trial Summary

This trial tests the effectiveness of a modular treatment to help people with anorexia overcome their fears of food, weight gain, and social situations.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves psychological therapy rather than medication there may be no direct 'side effects' as understood medically; however participants might experience emotional discomfort or anxiety when facing their eating disorder fears during the sessions.

FED-F Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Eating Disorders

Change in Eating Disorder Fear Inventory (EFI)

Change in Eating Disorder Fear Questionnaire (EFQ)

+3 more

Secondary outcome measures

Change in Behavioral Approach Task

Change in Behavioral Inhibition System/Behavioral Activation System (BIS/BAS)

Change in Mobile Assessment of Approach and Avoidance

+2 more

FED-F Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Facing Eating Disorder Fears ConditionExperimental Treatment1 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 UsualActive Control1 Intervention

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

Do I qualify?Apply below to find out

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

The most common treatments for Anorexia Nervosa, such as FED-F, CBT, and FBT, work by addressing the core fears and maladaptive behaviors associated with the disorder. FED-F enhances exposure therapy with psychoeducation and cognitive skills to help patients face their fears of food, weight gain, and social situations, thereby promoting approach behaviors. This is crucial for Anorexia Nervosa patients as it helps them gradually confront and overcome their anxieties, leading to healthier eating patterns and improved psychological well-being. These treatments aim to modify the underlying cognitive distortions and behavioral patterns, facilitating long-term recovery and reducing the risk of relapse.

Moderators and mediators of remission in family-based treatment and adolescent focused therapy for anorexia nervosa.I know what you did last summer (and it was not CBT): a factor analytic model of international psychotherapeutic practice in the eating disorders.

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Who is running the clinical trial?

University of LouisvilleLead Sponsor

339 Previous Clinical Trials

76,610 Total Patients Enrolled

3 Trials studying Anorexia Nervosa

381 Patients Enrolled for Anorexia Nervosa

National Institute of Mental Health (NIMH)NIH

2,799 Previous Clinical Trials

2,661,094 Total Patients Enrolled

47 Trials studying Anorexia Nervosa

22,773 Patients Enrolled for Anorexia Nervosa

Cheri A Levinson, Ph.D.Principal InvestigatorUniversity of Louisville

Media Library

Facing Eating Disorder Fears Condition Clinical Trial Eligibility Overview. Trial Name: NCT05596799 — N/A

Anorexia Nervosa Research Study Groups: Facing Eating Disorder Fears Condition, Treatment as Usual

Anorexia Nervosa Clinical Trial 2023: Facing Eating Disorder Fears Condition Highlights & Side Effects. Trial Name: NCT05596799 — N/A

Facing Eating Disorder Fears Condition 2023 Treatment Timeline for Medical Study. Trial Name: NCT05596799 — N/A

Anorexia Nervosa Patient Testimony for trial: Trial Name: NCT05596799 — N/A

~20 spots leftby Feb 2025

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