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Recruiting NCT05596799

Facing Eating Disorder Fears for Anorexia Nervosa

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

Sex: All
Ages: 18 Years – 65 Years
Phase: NA
Enrollment: 70
Sponsor: University of Louisville

Location: United States

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 Criteria:Age 18-65Meets criteria for DSM-5 defined AN, AN partial remission, or AN full remissionHas been discharged from intensive (i.e., inpatient, residential, or partial hospital program) in the past 6 monthsExclusion Criteria:Under 18Over 65Does not meet criteria for DSM-5 defined AN, AN partial-remission, or AN full-remissionHigh and active SuicidalityActive ManiaActive psychosisMedically Compromised Status including extremely low weight (less than or equal to 75% median BMI for age, sex, and height)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05596799). StuddyBuddy aggregates publicly available trial information.