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

Primary Purpose

Eating Disorders, Anorexia Nervosa, Anorexia Nervosa in Remission

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Facing Eating Disorder Fears Condition
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring therapy, eating disorder, anorexia nervosa, treatment, relapse prevention, virtual treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Eating Anxiety Laboratory and ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Facing Eating Disorder Fears Condition

Treatment as Usual

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
October 20, 2022
Last Updated
April 25, 2023
Sponsor
University of Louisville
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05596799
Brief Title
Facing Eating Disorder Fears for Anorexia Nervosa
Acronym
FED-F
Official Title
Facing Eating Disorder Fears for Anorexia Nervosa: A Virtual Relapse Prevention Program Targeted at Approach and Avoidance Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Anorexia Nervosa, Anorexia Nervosa in Remission
Keywords
therapy, eating disorder, anorexia nervosa, treatment, relapse prevention, virtual treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Facing Eating Disorder Fears Condition
Arm Type
Experimental
Arm 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.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Participants will complete baseline measures, mobile assessments and treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
Facing Eating Disorder Fears Condition
Intervention Description
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 Outcome Measure Information:
Title
Change in Structured Clinical Interview for DSM-5 (SCID-5)
Description
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.
Time Frame
Up to 2-month follow-up
Title
Change in Eating Disorder Fear Inventory (EFI)
Description
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.
Time Frame
Up to 2-month follow-up
Title
Change in Treatment Interview
Description
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.
Time Frame
Up to 2-month follow-up
Title
Change in Eating Disorder Examination Questionnaire 6.0 (EDE-Q)
Description
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.
Time Frame
Up to 2-month follow-up
Title
Change in Fear of Food Measure (FOFM)
Description
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.
Time Frame
Up to 2-month follow-up
Title
Change in Eating Disorder Fear Questionnaire (EFQ)
Description
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.
Time Frame
Up to 2-month follow-up
Secondary Outcome Measure Information:
Title
Change in Behavioral Approach Task
Description
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.
Time Frame
Up to 2-month follow-up
Title
Change in Behavioral Inhibition System/Behavioral Activation System (BIS/BAS)
Description
The Behavioral Inhibition System/Behavioral Activation System will assess avoidance and approach tendencies with a well-validated and established measure.
Time Frame
Up to 2-month follow-up
Title
Change in Subjective Units of Distress (SUDS)
Description
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).
Time Frame
Up to session 12
Title
Change in State Fear of Food Measure
Description
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.
Time Frame
Up to Session 12
Title
Change in Mobile Assessment of Approach and Avoidance
Description
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.
Time Frame
Up to Session 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheri A Levinson, Ph.D.
Phone
502-852-7710
Email
cheri.levinson@louisville.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Abigail M McCarthy, B.S.
Phone
502-230-1844
Email
abigail.mccarthy.1@louisville.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheri A Levinson, Ph.D.
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eating Anxiety Laboratory and Clinic
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheri A Levinson, Ph.D.
Phone
502-852-7710
Email
cheri.levinson@louisville.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20967242
Citation
Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010 Oct 13;5(10):e13196. doi: 10.1371/journal.pone.0013196.
Results Reference
background
PubMed Identifier
32725848
Citation
Carl JR, Miller CB, Henry AL, Davis ML, Stott R, Smits JAJ, Emsley R, Gu J, Shin O, Otto MW, Craske MG, Saunders KEA, Goodwin GM, Espie CA. Efficacy of digital cognitive behavioral therapy for moderate-to-severe symptoms of generalized anxiety disorder: A randomized controlled trial. Depress Anxiety. 2020 Dec;37(12):1168-1178. doi: 10.1002/da.23079. Epub 2020 Jul 29.
Results Reference
background
PubMed Identifier
32794449
Citation
Levinson CA, Christian C, Ram SS, Vanzhula I, Brosof LC, Michelson LP, Williams BM. Eating disorder symptoms and core eating disorder fears decrease during online imaginal exposure therapy for eating disorders. J Affect Disord. 2020 Nov 1;276:585-591. doi: 10.1016/j.jad.2020.07.075. Epub 2020 Jul 21.
Results Reference
background
PubMed Identifier
31735247
Citation
Farrell NR, Brosof LC, Vanzhula IA, Christian C, Bowie OR, Levinson CA. [Exploring Mechanisms of Action in Exposure-Based Cognitive Behavioral Therapy for Eating Disorders: The Role of Eating-Related Fears and Body-Related Safety Behaviors]. Behav Ther. 2019 Nov;50(6):1125-1135. doi: 10.1016/j.beth.2019.01.008. Epub 2019 Feb 12. French.
Results Reference
background
PubMed Identifier
32224363
Citation
Butler RM, Heimberg RG. Exposure therapy for eating disorders: A systematic review. Clin Psychol Rev. 2020 Jun;78:101851. doi: 10.1016/j.cpr.2020.101851. Epub 2020 Mar 21.
Results Reference
background

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Facing Eating Disorder Fears for Anorexia Nervosa

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