Eating Disorder SymptomCFFNCT04155788
Conquering Feared Foods Study
A study testing Food Exposure in people with Eating Disorder Symptom and Fear, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorder Symptom, Fear
- What is being tested?
- Food Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2018to 9 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40292
About this study
Official title: Food Exposure Therapy in Individuals With or Without Eating Disorders
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.
Read the 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.
- Conditions
- Eating Disorder Symptom, Fear
- Being tested
- Food Exposure
- Keywords
- eating disorder, food exposure, feared food
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food ExposureBehavioural
Participants will complete a meal exposure using one of their feared foods.
| Study group | Role | What they receive |
|---|---|---|
| Food Exposure | Experimental | Not described Receives: Behavioral: Food Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Reported Anxiety
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.
Measured: through study completion, an average of four weeks
Physiological Data
Changes in heart rate
Measured: through study completion, an average of four weeks
Participants' self-reported Safety Behaviors
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.
Measured: through study completion, an average of four weeks
Secondary outcomes (1)
Eating Disorder Symptoms & Behaviors
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.
Measured: through study completion, an average of four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start9 Mar 2018
- Primary completion8 Feb 2022
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating Disorder SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheri Levinson, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155788
- Sponsor's protocol ID
- IRB# 17.1288
- Acronym
- CFF
- Status last verified
- Apr 2022
- First submitted
- 16 Sep 2019
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simpson HB, Wetterneck CT, Cahill SP, Steinglass JE, Franklin ME, Leonard RC, Weltzin TE, Riemann BC. Treatment of obsessive-compulsive disorder complicated by comorbid eating disorders. Cogn Behav Ther. 2013;42(1):64-76. doi: 10.1080/16506073.2012.751124. Epub 2013 Jan 15.
PubMed 23316878
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Exposure Therapy in Individuals With or Without Eating Disorders
- ClinicalTrials.gov ID
- NCT04155788
- Acronym / sponsor ID
- CFF / IRB# 17.1288
- Conditions
- Eating Disorder Symptom, Fear
- Keywords
- eating disorder, food exposure, feared food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Food Exposure | Experimental | Behavioral: Food Exposure |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food ExposureParticipants will complete a meal exposure using one of their feared foods. | Behavioural | Food Exposure |
Primary outcome
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.
1 secondary outcome
Eating Disorder Symptoms & Behaviors
Time frame: through study completion, an average of four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Background: PubMed 23316878Simpson HB, Wetterneck CT, Cahill SP, Steinglass JE, Franklin ME, Leonard RC, Weltzin TE, Riemann BC. Treatment of obsessive-compulsive disorder complicated by comorbid eating disorders. Cogn Behav Ther. 2013;42(1):64-76. doi: 10.1080/16506073.2012.751124. Epub 2013 Jan 15.
- Laboratory Website Description of StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Exposure in people with Eating Disorder Symptom and Fear, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self Reported Anxiety (time frame: through study completion, an average of four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04155788, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.