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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

Find a Location

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

2,786 Previous Clinical Trials

2,689,629 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial include individuals who have surpassed their 75th birthdays?

"This particular clinical trial allows patients aged 18 to 65. For those who are younger or older, there is a total of 976 studies that may be suitable for their age group; 300 trials designed with minors in mind and 676 specifically tailored towards seniors."

Answered by AI

May I partake in this clinical experiment?

"This clinical trial is currently enrolling 70 individuals of legal age with anorexia nervosa or its variants. Participants must fit the DSM-5 criteria for AN, and have been discharged from intensive care within the past 6 months."

Answered by AI

Are there still opportunities for eligible individuals to join this research project?

"The listing on clinicaltrials.gov suggests that recruitment for this particular medical trial has ended; it was initially published in December 2022 before being edited last October. Nonetheless, there are still 1047 other studies seeking participants at the moment."

Answered by AI

What is the principal objective of this clinical experiment?

"This trial will observe the impact of treatment on participants' Fear of Food Measure (FOFM) over a two-month period. Secondary outcomes include, but are not limited to: State Fear of Food Measure related to food anxiety and avoidance; Behavioral Approach Task rating anxiousness in relation to feared stimuli; and an assessment of behavioural inhibition/activation tendencies with regard to approach or avoidance behaviours via the BIS/BAS measurement tool."

Answered by AI