Online Imaginal Exposure (Online IE)
Primary Purpose
Eating Disorder, Exposure, Anorexia Nervosa
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Imaginal Exposure therapy
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorder
Eligibility Criteria
Inclusion Criteria:
- At least 14 years of age (no age limit)
- Currently meet criteria for an eating disorder (using the eating disorder diagnostic scale), OR have met criteria for an eating disorder in the last year, OR endorse significant eating disorder fears
- At least one significant eating disorder related fear.
Exclusion Criteria:
- Under 14 years of age
- Do not meet eating disorder related criteria
- Do not meet criteria for mania, psychosis, or suicidal ideation will be excluded.
Sites / Locations
- Eating Anxiety Treatment Laboratory and Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Imaginal Exposure Session
Arm Description
Outcomes
Primary Outcome Measures
Eating disorder symptoms are assessed by the Eating Disorder Examination Questionnaire
The Eating Disorder Examination Questionnaire (EDEQ), a self-reported measure, is assessed at multiple time points throughout the duration of the study and is used to examine the attitudes and behaviors in individuals with eating disorder symptoms.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03712748
Brief Title
Online Imaginal Exposure
Acronym
Online IE
Official Title
Imaginal Exposure I Online Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 17, 2016 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates if imaginal exposure therapy can decrease symptoms of eating disorders and anxiety, and test an online format of IE to maximize its ability to reach as many individuals with eating disorders as possible. All participants will complete four imaginal exposure sessions and will complete questionnaires prior to receiving this treatment, as well as complete follow up questionnaires at 1-month, 6-month, and 12-month.
Detailed Description
Eating disorders (EDs) are tenacious mental disorders that are difficult to treat. EDs are often accompanied by anxiety disorders, which exacerbate the problem. Better ED treatments are imperative, and it is likely that targeting comorbid conditions, such as anxiety, will facilitate ED treatments.
Imaginal exposure is used in anxiety disorders to face fears that are not accessible or practical to address via in-vivo exposures. For example, a patient with PTSD cannot re-experience her trauma in real life, but she can imagine the past trauma and experience the subsequent anxiety. For patients with AN, catastrophic outcomes such as abandonment or immediate fatness are similarly impossible to recreate as in-vivo exposures. Patients cannot become fat solely for the purpose of the exposure, but they can imagine what it would be like to become fat. The investigators are unaware of any literature using imaginal exposure therapy to induce fears of fatness and conducted a case study to test whether imaginal exposure could, firstly, induce fears of fatness and then promote reduction in anxiety and eating disorder symptoms. In this case study, the investigators found that imaginal exposure therapy was effective at reducing anxiety and eating disorder behaviors. Imaginal exposure therapy (IE) has been shown to be an extremely effective treatment for Post-Traumatic Stress Disorder. IE has also been shown to be effective for the treatment of eating disorders using case studies. However, IE has not been systematically applied to the eating disorders. The purpose of this study is to test if 1) imaginal exposure therapy can decrease symptoms of eating disorders and anxiety, and 2) test an online format of IE to maximize its ability to reach as many individuals with eating disorders as possible.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder, Exposure, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will complete the same arm, which is four sessions of imaginal exposure across a one month time period. Each session is separated by 1 week.
Masking
None (Open Label)
Allocation
N/A
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Imaginal Exposure Session
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Imaginal Exposure therapy
Other Intervention Name(s)
Exposure Therapy
Intervention Description
All participants will complete the same arm, which is four sessions of imaginal exposure across a one month time period. Each session is separated by 1 week.
Primary Outcome Measure Information:
Title
Eating disorder symptoms are assessed by the Eating Disorder Examination Questionnaire
Description
The Eating Disorder Examination Questionnaire (EDEQ), a self-reported measure, is assessed at multiple time points throughout the duration of the study and is used to examine the attitudes and behaviors in individuals with eating disorder symptoms.
Time Frame
Up to 12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 14 years of age (no age limit)
Currently meet criteria for an eating disorder (using the eating disorder diagnostic scale), OR have met criteria for an eating disorder in the last year, OR endorse significant eating disorder fears
At least one significant eating disorder related fear.
Exclusion Criteria:
Under 14 years of age
Do not meet eating disorder related criteria
Do not meet criteria for mania, psychosis, or suicidal ideation will be excluded.
Facility Information:
Facility Name
Eating Anxiety Treatment Laboratory and Clinic
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24691784
Citation
Levinson CA, Rapp J, Riley EN. Addressing the fear of fat: extending imaginal exposure therapy for anxiety disorders to anorexia nervosa. Eat Weight Disord. 2014 Dec;19(4):521-4. doi: 10.1007/s40519-014-0115-6. Epub 2014 Apr 2. No abstract available.
Results Reference
background
PubMed Identifier
20127936
Citation
Steinglass JE, Sysko R, Glasofer D, Albano AM, Simpson HB, Walsh BT. Rationale for the application of exposure and response prevention to the treatment of anorexia nervosa. Int J Eat Disord. 2011 Mar;44(2):134-41. doi: 10.1002/eat.20784.
Results Reference
background
PubMed Identifier
24488838
Citation
Steinglass JE, Albano AM, Simpson HB, Wang Y, Zou J, Attia E, Walsh BT. Confronting fear using exposure and response prevention for anorexia nervosa: A randomized controlled pilot study. Int J Eat Disord. 2014 Mar;47(2):174-80. doi: 10.1002/eat.22214. Epub 2013 Nov 8.
Results Reference
background
PubMed Identifier
32794449
Citation
Levinson CA, Christian C, Ram SS, Vanzhula I, Brosof LC, Michelson LP, Williams BM. Eating disorder symptoms and core eating disorder fears decrease during online imaginal exposure therapy for eating disorders. J Affect Disord. 2020 Nov 1;276:585-591. doi: 10.1016/j.jad.2020.07.075. Epub 2020 Jul 21.
Results Reference
derived
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Online Imaginal Exposure
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