Facing Eating Disorder Fears for Anorexia Nervosa

Completed · Not applicable

Conditions studied: Eating Disorders, Anorexia Nervosa, Anorexia Nervosa in Remission

In brief

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).

Key facts

Study ID

NCT05596799

Run by

University of Louisville

People needed

70

Starts

2022-12-08

Expected to finish

2026-04-27

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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