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Conquering Feared Foods Study (CFF)

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ClinicalTrials.gov Identifier: NCT04155788
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Cheri Levinson, University of Louisville

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 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 : March 9, 2018
Estimated Primary Completion Date : March 9, 2021
Estimated Study Completion Date : March 9, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155788


Contacts
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Contact: Cheri A Levinson, Ph.D. (502) 852-7710 cheri.levinson@louisville.edu
Contact: Samantha P Spoor, B.S. (502) 208-9212 spspoo01@louisville.edu

Locations
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United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40292
Contact: Cheri A Levinson, Ph.D.    502-852-7710    cheri.levinson@louisville.edu   
Principal Investigator: Cheri A Levinson, Ph.D.         
Sponsors and Collaborators
University of Louisville
Additional Information:
Publications:
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Responsible Party: Cheri Levinson, Assistant Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT04155788    
Other Study ID Numbers: IRB# 17.1288
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cheri Levinson, University of Louisville:
eating disorder
food exposure
feared food
Additional relevant MeSH terms:
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Feeding and Eating Disorders
Mental Disorders