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Completed

NCT Number: NCT05596799

Facing Eating Disorder Fears for Anorexia Nervosa

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eating Anxiety Laboratory and Clinic

Louisville, Kentucky, 40205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Facing Eating Disorder Fears Condition

Behavioral

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).

Primary outcomes

  1. Change in Structured Clinical Interview for DSM-5 (SCID-5)

    Time frame: 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.

  2. Change in Eating Disorder Fear Inventory (EFI)

    Time frame: 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.

  3. Change in Treatment Interview

    Time frame: 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.

  4. Change in Eating Disorder Examination Questionnaire 6.0 (EDE-Q)

    Time frame: 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.

  5. Change in Fear of Food Measure (FOFM)

    Time frame: 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.

  6. Change in Eating Disorder Fear Questionnaire (EFQ)

    Time frame: 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 outcomes

  1. Change in Behavioral Approach Task

    Time frame: 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.

  2. Change in Behavioral Inhibition System/Behavioral Activation System (BIS/BAS)

    Time frame: 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.

  3. Change in Subjective Units of Distress (SUDS)

    Time frame: 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).

  4. Change in State Fear of Food Measure

    Time frame: 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.

  5. Change in Mobile Assessment of Approach and Avoidance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: FED-F

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 27, 2022
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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