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Conquering Feared Foods Study

Food Exposure Therapy in Individuals With or Without Eating Disorders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04155788
Acronym
CFF
Enrollment
24
Registered
2019-11-07
Start date
2018-03-09
Completion date
2022-03-09
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Disorder Symptom, Fear

Keywords

eating disorder, food exposure, feared food

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.

Interventions

BEHAVIORALFood Exposure

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

Sponsors

University of Louisville
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Self Reported Anxietythrough study completion, an average of four weeksChanges 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 Datathrough study completion, an average of four weeksChanges in heart rate
Participants' self-reported Safety Behaviorsthrough study completion, an average of four weeksChanges 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

MeasureTime frameDescription
Eating Disorder Symptoms & Behaviorsthrough study completion, an average of four weeksChanges in eating disordered symptoms and behaviors will be measured using a meal measure which identifies strategies used to avoid feelings of anxiety during meals.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026