NCT03712748

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

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

October 17, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

3.6 years

First QC Date

June 20, 2018

Last Update Submit

March 24, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 12 Months

Study Arms (1)

Imaginal Exposure Session

EXPERIMENTAL
Behavioral: Imaginal Exposure therapy

Interventions

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.

Also known as: Exposure Therapy
Imaginal Exposure Session

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eating Anxiety Treatment Laboratory and Clinic

Louisville, Kentucky, 40292, United States

Location

Related Publications (4)

  • 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.

    PMID: 24691784BACKGROUND
  • 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.

    PMID: 20127936BACKGROUND
  • 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.

    PMID: 24488838BACKGROUND
  • 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.

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexia NervosaBulimia NervosaBinge-Eating Disorder

Interventions

Implosive Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

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

Study Record Dates

First Submitted

June 20, 2018

First Posted

October 19, 2018

Study Start

October 17, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

March 25, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations