Facing Eating Disorder Fears for Anorexia Nervosa

NCT05596799 | Completed DMC

• 2 other identifiers: IRB#: 21.09921R34MH126965-01A1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Eating Disorders; Anorexia Nervosa; Anorexia Nervosa in Remission

Keywords

therapy; eating disorder; anorexia nervosa; treatment; relapse prevention; virtual treatment

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Change in Behavioral Approach Task

  Up to 2-month follow-up

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

  Up to 2-month follow-up

• Change in Subjective Units of Distress (SUDS)

  Up to session 12

• Change in State Fear of Food Measure

  Up to Session 12

• Change in Mobile Assessment of Approach and Avoidance

  Up to Session 12

Study Arms (2)

Facing Eating Disorder Fears Condition

EXPERIMENTAL

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

Treatment as Usual

NO INTERVENTION

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

Interventions

Facing Eating Disorder Fears Condition BEHAVIORAL

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).

Facing Eating Disorder Fears Condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Eating Anxiety Laboratory and Clinic

Louisville, Kentucky, 40205, United States

Location

Related Publications (5)

• 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.

  PMID: 20967242 BACKGROUND

• 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.

  PMID: 32725848 BACKGROUND

• 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.

  PMID: 32794449 BACKGROUND

• 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.

  PMID: 31735247 BACKGROUND

• 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.

  PMID: 32224363 BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Cheri A Levinson, Ph.D.

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 27, 2022
• Study Start: December 8, 2022
• Primary Completion: April 27, 2026
• Study Completion: April 27, 2026
• Last Updated: May 4, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)