FED-F: Facing Eating Disorder Fears for Anorexia Nervosa

Sponsor

University of Louisville (Other)

Overall Status

Recruiting

CT.gov ID

NCT05596799

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

25.8

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Eating Disorders Anorexia Nervosa Anorexia Nervosa in Remission	Behavioral: Facing Eating Disorder Fears Condition	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Facing Eating Disorder Fears for Anorexia Nervosa: A Virtual Relapse Prevention Program Targeted at Approach and Avoidance Behaviors

Actual Study Start Date :

Dec 8, 2022

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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).
No Intervention: Treatment as Usual Participants will complete baseline measures, mobile assessments and treatment as usual.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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).

No Intervention: Treatment as Usual

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

Outcome Measures

Primary Outcome Measures

Change in Structured Clinical Interview for DSM-5 (SCID-5) [Up to 2-month follow-up]
The SCID-5 is a semi-structured interview used to arrive at DSM-5 diagnoses. Participants will complete the ED, anxiety, depression, mania, psychosis, and suicide modules. SCID-5 has strong psychometric properties.
Change in Eating Disorder Fear Inventory (EFI) [Up to 2-month follow-up]
EFI is a semi-structured interview used to assess ED fears, such as fear of weight gain, food, and associated consequences. It will be used to generate fears to focus on during treatment and comprehensively assesses all domains of ED fear.
Change in Treatment Interview [Up to 2-month follow-up]
The Treatment Interview will assess all current and past treatment experiences (partial hospitalization, residential, etc.), as well as dates of treatment. It will also assess primary type of treatment (CBT vs supportive), as well as current usage of psychotropic medications and duration of illness.
Change in Eating Disorder Examination Questionnaire 6.0 (EDE-Q) [Up to 2-month follow-up]
The EDE-Q assesses ED behaviors, thoughts, and outcomes (e.g., fasting, binge eating). The EDE-Q has demonstrated excellent test-retest reliability, internal consistency, good criterion validity and concurrent validity.
Change in Fear of Food Measure (FOFM) [Up to 2-month follow-up]
The FOFM is a measure that assesses three cognitive-behavioral dimensions of fear of food: anxiety about food, food avoidance behaviors, and feared concerns (e.g., fear of weight gain). It has strong factor, convergent, divergent, and construct validity.
Change in Eating Disorder Fear Questionnaire (EFQ) [Up to 2-month follow-up]
The EFQ is a measure of five central ED fears: fear of weight gain, fear of social eating, fear of physical sensations, fear of social consequences (from gaining weight), fear of personal consequences (from gaining weight). EFQ has strong factor, convergent, and construct validity and assesses multiple domains of ED fear.

Secondary Outcome Measures

Change in Behavioral Approach Task [Up to 2-month follow-up]
The Behavioral Approach Task will be used at each diagnostic assessment. It is a standardized behavioral rating task adapted from Ritzert (2017) for use with specific phobias. This task asks participants to rate their anxiety and likelihood to avoid feared stimuli (e.g., pizza, grocery stores, tight jeans) and is adapted from behavioral ratings obtained when building an exposure hierarchy for the treatment of AN fear, which has been implemented in over 200 patients with AN.
Change in Behavioral Inhibition System/Behavioral Activation System (BIS/BAS) [Up to 2-month follow-up]
The Behavioral Inhibition System/Behavioral Activation System will assess avoidance and approach tendencies with a well-validated and established measure.
Change in Subjective Units of Distress (SUDS) [Up to session 12]
SUDS is a behavioral measure used during exposure treatment to measure anxiety and will be collected throughout each treatment session. The SUDS scale has been shown to be a valid and reliable measure of state anxiety. SUDS ratings can range from 0 (completely calm) to 100 (highest anxiety).
Change in State Fear of Food Measure [Up to Session 12]
The state version of the fear of food measure, which assesses food anxiety, food avoidance, and feared concerns (e.g., weight gain), will be used during sessions. This measure will be collected at the beginning and end of each therapy session.
Change in Mobile Assessment of Approach and Avoidance [Up to Session 12]
Real-world approach and avoidance behaviors will be assessed via mobile assessment. While momentary assessment is a newer and more innovative method of assessing approach tendencies, the usage of self-report, behavioral, and momentary data will provide the opportunity to compare assessment methodologies in preparation for usage in a larger R01 RCT.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-65
Meets criteria for DSM-5 defined AN, AN partial remission, or AN 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)