Clinical trial NCT03712748: Online Imaginal Exposure
Official title: Imaginal Exposure I Online Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder
Exposure
Anorexia Nervosa
Bulimia Nervosa
Binge-Eating Disorder
Therapy
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 208
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Eating disorder symptoms are assessed by the Eating Disorder Examination Questionnaire
timeFrame: Up to 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Eating Anxiety Treatment Laboratory and Clinic
state: Kentucky
Study officials:
References:
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.
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.
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.
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.