- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04155788
Conquering Feared Foods Study (CFF)
Food Exposure Therapy in Individuals With or Without Eating Disorders
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kentucky
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Louisville, Kentucky, United States, 40292
- University of Louisville
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Food Exposure
|
Participants will complete a meal exposure using one of their feared foods.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
through study completion, an average of four weeks
|
Physiological Data
Time Frame: through study completion, an average of four weeks
|
Changes in heart rate
|
through study completion, an average of four weeks
|
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.
|
through study completion, an average of four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
through study completion, an average of four weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB# 17.1288
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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