Facing Eating Disorder Fears for Anorexia Nervosa (FED-F)

University of Louisville (UOFL)

Status: Enrolling

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

Treatments: Behavioral: Facing Eating Disorder Fears Condition

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05596799

1R34MH126965-01A1 (U.S. NIH Grant/Contract)

IRB#: 21.0992

Details and patient eligibility

About

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).

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Facing Eating Disorder Fears Condition

Experimental group

Description:

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.

Treatment:

Behavioral: Facing Eating Disorder Fears Condition

Treatment as Usual

No Intervention group

Description:

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