Online Imaginal Exposure (Online IE)
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| ClinicalTrials.gov Identifier: NCT03712748 |
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Recruitment Status :
Completed
First Posted : October 19, 2018
Last Update Posted : March 25, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Eating Disorder Exposure Anorexia Nervosa Bulimia Nervosa Binge-Eating Disorder Therapy | Behavioral: Imaginal Exposure therapy | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 208 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 |
| Actual Primary Completion Date : | June 1, 2020 |
| Actual Study Completion Date : | June 1, 2020 |
| 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 |
- 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.
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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 |
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.
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
| United States, Kentucky | |
| Eating Anxiety Treatment Laboratory and Clinic | |
| Louisville, Kentucky, United States, 40292 | |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | March 25, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 Hyperphagia |