NCT04155788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2022

Completed
Last Updated

April 4, 2022

Status Verified

April 1, 2022

Enrollment Period

3.9 years

First QC Date

September 16, 2019

Last Update Submit

April 1, 2022

Conditions

Eating Disorder SymptomFear

Keywords

eating disorderfood exposurefeared food

Outcome Measures

Primary Outcomes (3)

  • 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.

    through study completion, an average of four weeks

  • Physiological Data

    Changes in heart rate

    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.

    through study completion, an average of four weeks

Secondary Outcomes (1)

  • Eating Disorder Symptoms & Behaviors

    through study completion, an average of four weeks

Study Arms (1)

Food Exposure

EXPERIMENTAL
Behavioral: Food Exposure

Interventions

Food ExposureBEHAVIORAL

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

Food Exposure

Eligibility Criteria

Age13 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40292, United States

Location

Related Publications (1)

  • 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.

    PMID: 23316878BACKGROUND

Related Links

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 16, 2019

First Posted

November 7, 2019

Study Start

March 9, 2018

Primary Completion

February 8, 2022

Study Completion

March 9, 2022

Last Updated

April 4, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)