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Online Imaginal Exposure (Online IE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03712748
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Cheri Levinson, University of Louisville

Study Description
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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.

Condition or disease Intervention/treatment Phase
Eating Disorder Exposure Anorexia Nervosa Bulimia Nervosa Binge-Eating Disorder Therapy Behavioral: Imaginal Exposure therapy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 215 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Imaginal Exposure I Online Study
Actual Study Start Date : October 17, 2016
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Imaginal Exposure Session Behavioral: Imaginal Exposure therapy
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.
Other Name: Exposure Therapy


Outcome Measures
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Primary Outcome Measures :
  1. Eating disorder symptoms are assessed by the Eating Disorder Examination Questionnaire [ Time Frame: Up to 12 Months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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): NCT03712748


Contacts
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Contact: Cheri A Levinson 502-852-7710 cheri.levinson@louisville.edu

Locations
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United States, Kentucky
Eating Anxiety Treatment Laboratory and Clinic Recruiting
Louisville, Kentucky, United States, 40292
Contact: Cheri A Levinson, Ph.D.         
Sponsors and Collaborators
University of Louisville
More Information
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Publications:

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Responsible Party: Cheri Levinson, Director, University of Louisville
ClinicalTrials.gov Identifier: NCT03712748    
Other Study ID Numbers: IRB#:16.0771
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
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
Additional relevant MeSH terms:
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Disease
Anorexia
Bulimia
Feeding and Eating Disorders
Anorexia Nervosa
Binge-Eating Disorder
 Bulimia Nervosa
Pathologic Processes
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Hyperphagia