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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

Summary

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.

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.
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.
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.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Eating Disorders
Change in Eating Disorder Fear Inventory (EFI)
Change in Eating Disorder Fear Questionnaire (EFQ)
+3 more
Secondary study objectives
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

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.

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.

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
343 Previous Clinical Trials
77,463 Total Patients Enrolled
3 Trials studying Anorexia Nervosa
381 Patients Enrolled for Anorexia Nervosa
National Institute of Mental Health (NIMH)NIH
2,886 Previous Clinical Trials
2,721,724 Total Patients Enrolled
48 Trials studying Anorexia Nervosa
42,726 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
~8 spots leftby Feb 2025