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
|Condition or disease||Intervention/treatment||Phase|
|Eating Disorder Symptom Fear||Behavioral: Food Exposure||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Food Exposure||
Behavioral: Food Exposure
Participants will complete a meal exposure using one of their feared foods.
- 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.
- Physiological Data [ Time Frame: through study completion, an average of four weeks ]Changes in heart rate
- 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.
- 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.
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
|Contact: Cheri A Levinson, Ph.D.||(502) firstname.lastname@example.org|
|Contact: Samantha P Spoor, B.S.||(502) email@example.com|
|United States, Kentucky|
|University of Louisville||Recruiting|
|Louisville, Kentucky, United States, 40292|
|Contact: Cheri A Levinson, Ph.D. 502-852-7710 firstname.lastname@example.org|
|Principal Investigator: Cheri A Levinson, Ph.D.|