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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 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
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 moreSecondary 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 moreTrial 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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have anorexia or am not in remission from it.I have been diagnosed with anorexia or atypical anorexia, including any stage of remission.I am over 65 years old.I am younger than 18 years old.My weight is extremely low for my age, sex, and height.I am between 18 and 65 years old.I do not have anorexia nervosa according to DSM-5.I was discharged from a hospital or intensive care unit less than 6 months ago.I haven't been in intensive care or a hospital program for the past 6 months.I have been diagnosed with anorexia or am in partial/full recovery.
Research Study Groups:
This trial has the following groups:- Group 1: Facing Eating Disorder Fears Condition
- Group 2: Treatment as Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Anorexia Nervosa Patient Testimony for trial: Trial Name: NCT05596799 — N/A
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