Conquering Feared Foods Study

Fear Clinical Trial

— CFF  

Official title:

Food Exposure Therapy in Individuals With or Without Eating Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04155788
• Other study ID #: IRB# 17.1288
• Status: Completed
• Phase: N/A
• Start date: March 9, 2018
• Est. completion date: March 9, 2022

Study information

• Verified date: April 2022
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 9, 2022
• Est. primary completion date: February 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eating Disorder Symptom
• Fear
• Feeding and Eating Disorders

Intervention

Behavioral:
• Food Exposure
Participants will complete a meal exposure using one of their feared foods.

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of four weeks
Primary	Physiological Data	Changes in heart rate	through study completion, an average of four weeks
Primary	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.	through study completion, an average of four weeks
Secondary	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.	through study completion, an average of four weeks

External Links

•   Laboratory Website Description of Study