Facing Eating Disorder Fears for Anorexia Nervosa

NCT ID: NCT05596799

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-08
• Study Completion Date: 2025-08-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Facing Eating Disorder Fears Condition

Intervention Type: 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).

Treatment as Usual

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Cheri Levinson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheri A Levinson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

Eating Anxiety Laboratory and Clinic

Louisville, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cheri A Levinson, Ph.D.

Role: CONTACT

cheri.levinson@louisville.edu

502-852-7710

Abigail M McCarthy, B.S.

Role: CONTACT

abigail.mccarthy.1@louisville.edu

502-230-1844

Facility Contacts

Cheri A Levinson, Ph.D.

Role: primary

cheri.levinson@louisville.edu

502-852-7710

References

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.

Reference Type: BACKGROUND

PMID: 20967242 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32725848 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32794449 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31735247 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32224363 (View on PubMed)

Other Identifiers

1R34MH126965-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB#: 21.0992

Identifier Type: -

Identifier Source: org_study_id