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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05596799
Recruitment Status : Recruiting
First Posted : October 27, 2022
Last Update Posted : December 22, 2022
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Cheri Levinson, University of Louisville

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 8, 2022
Estimated Primary Completion Date : February 1, 2025
Estimated Study Completion Date : February 1, 2025

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05596799


Contacts
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Contact: Cheri A Levinson, Ph.D. 502-852-7710 cheri.levinson@louisville.edu
Contact: Abigail M McCarthy, B.S. 502-230-1844 abigail.mccarthy.1@louisville.edu

Locations
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United States, Kentucky
Eating Anxiety Laboratory and Clinic Recruiting
Louisville, Kentucky, United States, 40205
Contact: Cheri A Levinson, Ph.D.    502-852-7710    cheri.levinson@louisville.edu   
Sponsors and Collaborators
University of Louisville
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Cheri A Levinson, Ph.D. University of Louisville
Publications:
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Responsible Party: Cheri Levinson, Associate Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT05596799    
Other Study ID Numbers: IRB#: 21.0992
1R34MH126965-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 27, 2022    Key Record Dates
Last Update Posted: December 22, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cheri Levinson, University of Louisville:
therapy
eating disorder
anorexia nervosa
treatment
relapse prevention
virtual treatment
Additional relevant MeSH terms:
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Disease
Anorexia
Feeding and Eating Disorders
Anorexia Nervosa
Pathologic Processes
Mental Disorders
Signs and Symptoms, Digestive