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

Facing Eating Disorder Fears for Anorexia Nervosa: A Virtual Relapse Prevention Program Targeted at Approach and Avoidance Behaviors

FED-F is a modular treatment that enhances exposure therapy with psychoeducation and cognitive skills teaching how to face fears of (a) food, (b) weight gain, (c) interoception/body, and (d) social situations. The study goals are to (1) refine and test the acceptability and feasibility of FED-F treatment (Phase I), (2) test if this treatment outperforms treatment as usual (TAU) delivered post-acute treatment as adjunctive to stepdown specialty care (Phase II), and (3) to examine if treatment targets the hypothesized mechanism of action: approach behaviors (Phase II). These goals will lead to a highly deployable and accessible virtual treatment targeted at core AN mechanisms that predict relapse. Specific aims are to (1) refine FED-F into a fully virtual format with input from patients and stakeholders and collect preliminary data (N=10) on its feasibility and acceptability (Phase I), (2) conduct a small pilot RCT (randomized controlled trial) of FED-F (n=30) as compared to TAU (n=30; Phase II), and (3) examine if FED-F targets approach/avoidance behaviors and test if this mechanism is associated with clinical outcomes (Phase II).

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa; Eating Disorders; Anorexia Nervosa in Remission
• Intervention / Treatment: Behavioral: Facing Eating Disorder Fears Condition

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40205
      • Eating Anxiety Laboratory and Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-65
• Meets criteria for DSM-5 defined AN, AN partial remission, or AN full remission, Atypical Anorexia Nervosa (AAN), AAN partial remission, or AAN full remission
• Has been discharged from intensive (i.e., inpatient, residential, or partial hospital program) in the past 6 months

Exclusion Criteria:

• Under 18
• Over 65
• Does not meet criteria for DSM-5 defined AN, AN partial-remission, or AN full-remission
• High and active Suicidality
• Active Mania
• Active psychosis
• Medically Compromised Status including extremely low weight (less than or equal to 75% median BMI for age, sex, and height)
• Does not meet criteria for DSM-5 defined AN, AN partial remission, or AN full remission, AAN, AAN partial remission, or AAN full remission
• Has not been discharged from intensive (i.e., inpatient, residential, or partial hospital program) in the past 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Facing Eating Disorder Fears Condition; 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.	Behavioral: Facing Eating Disorder Fears Condition; The first session consists of diagnosis and general psychoeducation on anorexia nervosa and treatment for anorexia nervosa. After psychoeducation and baseline questionnaires are complete, sessions 2-12 include exposure-based virtual treatment for common eating disorder fears (food, weight gain, body sensations, and social situations).
No Intervention: Treatment as Usual; Participants will complete baseline measures, mobile assessments and treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Structured Clinical Interview for DSM-5 (SCID-5)	The SCID-5 is a semi-structured interview used to arrive at DSM-5 diagnoses. Participants will complete the ED, anxiety, depression, mania, psychosis, and suicide modules. SCID-5 has strong psychometric properties.	Up to 2-month follow-up
Change in Eating Disorder Fear Inventory (EFI)	EFI is a semi-structured interview used to assess ED fears, such as fear of weight gain, food, and associated consequences. It will be used to generate fears to focus on during treatment and comprehensively assesses all domains of ED fear.	Up to 2-month follow-up
Change in Treatment Interview	The Treatment Interview will assess all current and past treatment experiences (partial hospitalization, residential, etc.), as well as dates of treatment. It will also assess primary type of treatment (CBT vs supportive), as well as current usage of psychotropic medications and duration of illness.	Up to 2-month follow-up
Change in Eating Disorder Examination Questionnaire 6.0 (EDE-Q)	The EDE-Q assesses ED behaviors, thoughts, and outcomes (e.g., fasting, binge eating). The EDE-Q has demonstrated excellent test-retest reliability, internal consistency, good criterion validity and concurrent validity.	Up to 2-month follow-up
Change in Fear of Food Measure (FOFM)	The FOFM is a measure that assesses three cognitive-behavioral dimensions of fear of food: anxiety about food, food avoidance behaviors, and feared concerns (e.g., fear of weight gain). It has strong factor, convergent, divergent, and construct validity.	Up to 2-month follow-up
Change in Eating Disorder Fear Questionnaire (EFQ)	The EFQ is a measure of five central ED fears: fear of weight gain, fear of social eating, fear of physical sensations, fear of social consequences (from gaining weight), fear of personal consequences (from gaining weight). EFQ has strong factor, convergent, and construct validity and assesses multiple domains of ED fear.	Up to 2-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Behavioral Approach Task	The Behavioral Approach Task will be used at each diagnostic assessment. It is a standardized behavioral rating task adapted from Ritzert (2017) for use with specific phobias. This task asks participants to rate their anxiety and likelihood to avoid feared stimuli (e.g., pizza, grocery stores, tight jeans) and is adapted from behavioral ratings obtained when building an exposure hierarchy for the treatment of AN fear, which has been implemented in over 200 patients with AN.	Up to 2-month follow-up
Change in Behavioral Inhibition System/Behavioral Activation System (BIS/BAS)	The Behavioral Inhibition System/Behavioral Activation System will assess avoidance and approach tendencies with a well-validated and established measure.	Up to 2-month follow-up
Change in Subjective Units of Distress (SUDS)	SUDS is a behavioral measure used during exposure treatment to measure anxiety and will be collected throughout each treatment session. The SUDS scale has been shown to be a valid and reliable measure of state anxiety. SUDS ratings can range from 0 (completely calm) to 100 (highest anxiety).	Up to session 12
Change in State Fear of Food Measure	The state version of the fear of food measure, which assesses food anxiety, food avoidance, and feared concerns (e.g., weight gain), will be used during sessions. This measure will be collected at the beginning and end of each therapy session.	Up to Session 12
Change in Mobile Assessment of Approach and Avoidance	Real-world approach and avoidance behaviors will be assessed via mobile assessment. While momentary assessment is a newer and more innovative method of assessing approach tendencies, the usage of self-report, behavioral, and momentary data will provide the opportunity to compare assessment methodologies in preparation for usage in a larger R01 RCT.	Up to Session 12

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Cheri A Levinson, Ph.D., University of Louisville

Publications and helpful links

General Publications

• Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010 Oct 13;5(10):e13196. doi: 10.1371/journal.pone.0013196.
• Carl JR, Miller CB, Henry AL, Davis ML, Stott R, Smits JAJ, Emsley R, Gu J, Shin O, Otto MW, Craske MG, Saunders KEA, Goodwin GM, Espie CA. Efficacy of digital cognitive behavioral therapy for moderate-to-severe symptoms of generalized anxiety disorder: A randomized controlled trial. Depress Anxiety. 2020 Dec;37(12):1168-1178. doi: 10.1002/da.23079. Epub 2020 Jul 29.
• Levinson CA, Christian C, Ram SS, Vanzhula I, Brosof LC, Michelson LP, Williams BM. Eating disorder symptoms and core eating disorder fears decrease during online imaginal exposure therapy for eating disorders. J Affect Disord. 2020 Nov 1;276:585-591. doi: 10.1016/j.jad.2020.07.075. Epub 2020 Jul 21.
• Farrell NR, Brosof LC, Vanzhula IA, Christian C, Bowie OR, Levinson CA. [Exploring Mechanisms of Action in Exposure-Based Cognitive Behavioral Therapy for Eating Disorders: The Role of Eating-Related Fears and Body-Related Safety Behaviors]. Behav Ther. 2019 Nov;50(6):1125-1135. doi: 10.1016/j.beth.2019.01.008. Epub 2019 Feb 12. French.
• Butler RM, Heimberg RG. Exposure therapy for eating disorders: A systematic review. Clin Psychol Rev. 2020 Jun;78:101851. doi: 10.1016/j.cpr.2020.101851. Epub 2020 Mar 21.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2022
• Primary Completion (Actual): April 27, 2026
• Study Completion (Actual): April 27, 2026

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: treatment; relapse prevention; anorexia nervosa; therapy; eating disorder; virtual treatment
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Feeding and Eating Disorders; Anorexia Nervosa
• Other Study ID Numbers: IRB#: 21.0992; 1R34MH126965-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No