Facing Eating Disorder Fears for Anorexia Nervosa

Last updated: March 25, 2025
Sponsor: University of Louisville
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mood Disorders

Vomiting

Anorexia

Treatment

Facing Eating Disorder Fears Condition

Clinical Study ID

NCT05596799
IRB#: 21.0992
1R34MH126965-01A1
  • Ages 18-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 partialhospital program) in the past 6 months

Exclusion

Exclusion Criteria:

  • Under 18

  • Over 65

  • Does not meet criteria for DSM-5 defined AN, AN partial-remission, or ANfull-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 fullremission, AAN, AAN partial remission, or AAN full remission

  • Has not been discharged from intensive (i.e., inpatient, residential, or partialhospital program) in the past 6 months

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Facing Eating Disorder Fears Condition
Phase:
Study Start date:
December 08, 2022
Estimated Completion Date:
August 01, 2025

Connect with a study center

  • Eating Anxiety Laboratory and Clinic

    Louisville, Kentucky 40205
    United States

    Active - Recruiting

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