Clinical trial NCT04155788: Conquering Feared Foods Study
Official title: Food Exposure Therapy in Individuals With or Without Eating Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder Symptom
Fear
Keywords: eating disorder
food exposure
feared food
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 24
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Self Reported Anxiety
timeFrame: through study completion, an average of four weeks
measure: Physiological Data
timeFrame: through study completion, an average of four weeks
measure: Participants' self-reported Safety Behaviors
timeFrame: through study completion, an average of four weeks
Secondary outcomes:
measure: Eating Disorder Symptoms & Behaviors
timeFrame: through study completion, an average of four weeks
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
References:
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.