Conquering Feared Foods Study (CFF)
Primary Purpose
Eating Disorder Symptom, Fear
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food Exposure
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorder Symptom focused on measuring eating disorder, food exposure, feared food
Eligibility Criteria
Inclusion Criteria:
- Participants must be between the ages of 13-65, must meet criteria for a current diagnosis of anorexia nervosa or bulimia nervosa.
- Must be local to the Louisville area or able to travel to the study location for the two lab sessions.
- For participants to be in the control group, participants must be between the ages of 13-65.
- Must be local to the Louisville area or able to travel to the study location for the two lab sessions
Exclusion Criteria:
- Participants who are younger than 13 or older than 65 at the time of enrollment.
- Participants who are not local or can not travel to the Louisville area for the two therapy sessions.
- We will also exclude anyone who is actively suicidal (e.g., has a suicide plan), psychotic, or manic.
Sites / Locations
- University of Louisville
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Food Exposure
Arm Description
Outcomes
Primary Outcome Measures
Self Reported Anxiety
Changes in Subjective Units of Distress Scale (SUDS) Ratings. The SUDS measures subjective units of distress on a scale from 0-100 where 0 indicates no anxiety and 100 indicates the most anxiety one has ever felt or could imagine feeling.
Physiological Data
Changes in heart rate
Participants' self-reported Safety Behaviors
Changes in behaviors done to alleviate anxiety as reported via open-ended questions about mealtimes. Prior to the study, participants are provided a brief training to understand common safety behaviors in eating disorders. Then, throughout the food exposure, they are periodically asked to identify any safety behaviors they are currently engaging in.
Secondary Outcome Measures
Eating Disorder Symptoms & Behaviors
Changes in eating disordered symptoms and behaviors will be measured using a meal measure which identifies strategies used to avoid feelings of anxiety during meals.
Full Information
NCT ID
NCT04155788
First Posted
September 16, 2019
Last Updated
April 1, 2022
Sponsor
University of Louisville
1. Study Identification
Unique Protocol Identification Number
NCT04155788
Brief Title
Conquering Feared Foods Study
Acronym
CFF
Official Title
Food Exposure Therapy in Individuals With or Without Eating Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 9, 2018 (Actual)
Primary Completion Date
February 8, 2022 (Actual)
Study Completion Date
March 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to use ecological momentary assessment (EMA) data and physiological data to asses a client's eating disorder symptoms and behaviors before and after a meal with a feared food. The investigators are conducting a pilot clinical measurement study. Participants will be screened for eating disorder symptoms via a structured clinical interview. Participants with or without eating disorders will also complete self-reported measures of eating disorder symptoms and anxiety. Participants with eating disorders will complete assessments on their phone and will wear a sensor band to assess heart rate and galvanic skin response.
Detailed Description
Exposure therapy has been used in the treatment of Anorexia Nervosa (AN), as seen in mirror exposure to address body image and anxiety, as well as food exposure to address avoidant eating behavior. In food exposure therapy, individuals are exposed to feared foods in a clinical and/or non-clinical setting. Food exposure therapy has been effective in alleviating some anxiety in individuals with eating disorder behaviors and symptoms. However, the investigators do not yet know what characteristics predict response in food exposure therapy. The purpose of this study is to use EMA data and physiological data to asses a client's eating disorder symptoms and behaviors before and after a meal with a feared food.
Lastly, the study would like to utilize individuals who do not meet criteria for an eating disorder (ED) and will act as controls in this study to address the research question: is there a difference between individuals with EDs and without EDs as they complete the entirety of the study, specifically in regards to physiological data? These controls will not complete the EMA data aspect of the study.
The investigators are conducting a pilot clinical measurement study. Participants will be screened for eating disorder symptoms via a structured clinical interview or determined to not have eating disorder symptoms and will act as controls in the study. Both groups will also complete self-reported measures of eating disorder symptoms and anxiety. Participants will also complete assessments on their phone and will wear a sensor band to assess heart rate and galvanic skin response. However, control participants will not complete assessments on their phone. Both groups will wear the health-sensor band to assess heart rate and galvanic skin response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder Symptom, Fear
Keywords
eating disorder, food exposure, feared food
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Food Exposure
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Food Exposure
Intervention Description
Participants will complete a meal exposure using one of their feared foods.
Primary Outcome Measure Information:
Title
Self Reported Anxiety
Description
Changes in Subjective Units of Distress Scale (SUDS) Ratings. The SUDS measures subjective units of distress on a scale from 0-100 where 0 indicates no anxiety and 100 indicates the most anxiety one has ever felt or could imagine feeling.
Time Frame
through study completion, an average of four weeks
Title
Physiological Data
Description
Changes in heart rate
Time Frame
through study completion, an average of four weeks
Title
Participants' self-reported Safety Behaviors
Description
Changes in behaviors done to alleviate anxiety as reported via open-ended questions about mealtimes. Prior to the study, participants are provided a brief training to understand common safety behaviors in eating disorders. Then, throughout the food exposure, they are periodically asked to identify any safety behaviors they are currently engaging in.
Time Frame
through study completion, an average of four weeks
Secondary Outcome Measure Information:
Title
Eating Disorder Symptoms & Behaviors
Description
Changes in eating disordered symptoms and behaviors will be measured using a meal measure which identifies strategies used to avoid feelings of anxiety during meals.
Time Frame
through study completion, an average of four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants must be between the ages of 13-65, must meet criteria for a current diagnosis of anorexia nervosa or bulimia nervosa.
Must be local to the Louisville area or able to travel to the study location for the two lab sessions.
For participants to be in the control group, participants must be between the ages of 13-65.
Must be local to the Louisville area or able to travel to the study location for the two lab sessions
Exclusion Criteria:
Participants who are younger than 13 or older than 65 at the time of enrollment.
Participants who are not local or can not travel to the Louisville area for the two therapy sessions.
We will also exclude anyone who is actively suicidal (e.g., has a suicide plan), psychotic, or manic.
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23316878
Citation
Simpson HB, Wetterneck CT, Cahill SP, Steinglass JE, Franklin ME, Leonard RC, Weltzin TE, Riemann BC. Treatment of obsessive-compulsive disorder complicated by comorbid eating disorders. Cogn Behav Ther. 2013;42(1):64-76. doi: 10.1080/16506073.2012.751124. Epub 2013 Jan 15.
Results Reference
background
Links:
URL
http://www.louisvilleeatlab.com/conquering-fear-foods-study.html
Description
Laboratory Website Description of Study
Learn more about this trial
Conquering Feared Foods Study
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