CFF: Conquering Feared Foods Study

Sponsor

University of Louisville (Other)

Overall Status

Completed

CT.gov ID

NCT04155788

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Eating Disorder Symptom Fear	Behavioral: Food Exposure	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Food Exposure Therapy in Individuals With or Without Eating Disorders

Actual Study Start Date :

Mar 9, 2018

Actual Primary Completion Date :

Feb 8, 2022

Actual Study Completion Date :

Mar 9, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Food Exposure	Behavioral: Food Exposure Participants will complete a meal exposure using one of their feared foods.

Arm

Intervention/Treatment

Experimental: Food Exposure

Behavioral: Food Exposure

Participants will complete a meal exposure using one of their feared foods.

Outcome Measures

Primary Outcome Measures

Self Reported Anxiety [through study completion, an average of four weeks]
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 [through study completion, an average of four weeks]
Changes in heart rate
Participants' self-reported Safety Behaviors [through study completion, an average of four weeks]
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 [through study completion, an average of four weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.