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Completed

NCT Number: NCT04155788

Conquering Feared Foods Study

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.

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Key information

Conditions

Eating Disorder Symptom Fear Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

13 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville

Louisville, Kentucky, 40292, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Food Exposure

Behavioral

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

Primary outcomes

  1. Self Reported Anxiety

    Time frame: 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.

  2. Physiological Data

    Time frame: through study completion, an average of four weeks

    Changes in heart rate

  3. Participants' self-reported Safety Behaviors

    Time frame: 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 outcomes

  1. Eating Disorder Symptoms & Behaviors

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

Food Exposure Therapy in Individuals With or Without Eating Disorders

Acronym: CFF

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 7, 2019
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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