Imaginal Exposure II Study: In-Vivo

NCT03934697 | Completed

• 1 other identifier: IRB#:16.1003
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test if imaginal exposure therapy can decrease symptoms of eating disorders and anxiety.

Conditions

Eating Disorder; Anorexia Nervosa; Bulimia Nervosa; Exposure

Keywords

Eating Disorder; Anorexia Nervosa; Bulimia Nervosa; Imaginal Exposure Therapy

Outcome Measures

Primary Outcomes (3)

• EDEQ (Eating Disorder Examination Questionnaire) at 1-10 Weeks and at 1 year

  The EDE-Q is a 41-item self-report questionnaire version of the Eating Disorder Examination, which is a semi-structured interview designed to assess eating disorders symptom frequency and severity over the past 28 days. The EDE-Q uses a 7-point forced-choice rating scheme (No days; 1-5 days; 6-12 days; 13-15 days; 16-22 days; 23-27 days; Everyday). The EDE-Q has four subscales with the question stem "How many days out of the past 28 days...": Restraint (e.g. Have you been consciously trying to restrict the amount of food you eat to influence your shape or weight?), Eating Concern (e.g. Have you had a definite fear that you might not be able to either resist eating or stop eating?), Weight Concern (e.g. Has your weight influenced how you think about (judge) yourself as a person?), and Shape Concern (e.g. How dissatisfied have you felt about your shape?).

  1 year and 10 weeks

• SUDS (Subjective Units of Distress Scale) at 1-10 Weeks and at 1 year

  The SUDS scale is a self-report behavioral measure used during exposure treatment and behavioral assessment to measure anxiety. The SUDS scale has been shown to be a valid and reliable measure of state anxiety. SUDS ratings can range from 0 (completely calm) to 100 (highest anxiety). Other reference points used in this study include 25 (noticeable, but not bothersome anxiety), 50 (bothersome anxiety), and 75 (very bothersome anxiety). Subjective anxiety was assessed both in terms of categorical response and overall change. Categorical response was defined as a drop of at least five points in average SUDS across the exposure across visits.

  1 year and 10 weeks

• Body Mass Index (BMI) at 1-10 Weeks and at 1 year

  Participants will be weighed at 1-10 Weeks and at 1 year and BMI will be calculated in order to see if the BMI of an individual has changed over time.

  1 year and 10 weeks

Study Arms (1)

Imaginal Exposure Session

EXPERIMENTAL

All participants will complete the same arm, which is ten sessions of imaginal exposure across a ten week time period. Each session is separated by 1 week.

Behavioral: imaginal exposure therapy

Interventions

imaginal exposure therapy BEHAVIORAL

All participants will complete the same arm, which is ten sessions of imaginal exposure across a ten week time period. Each session is separated by 1 week.

Also known as: Exposure Therapy

Imaginal Exposure Session

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 18 years of age (no age limit)
• Must currently meet criteria for anorexia, sub-clinical anorexia, bulimia, or sub-clinical bulimia (using the eating disorder diagnostic scale), OR have met criteria for one of these eating disorders in the last year, OR endorse significant eating disorder fears
• Must have at least one significant eating disorder related fear.

You may not qualify if:

• Under 18 years of age
• Individuals who have binge eating disorder or an unspecified eating disorder, OR who do not meet eating disorder related criteria
• Individuals who meet criteria for mania, psychosis, or suicidal ideation
• Participants who are not able to secure transportation to complete therapy sessions

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Eating Anxiety Treatment Laboratory and Clinic

Louisville, Kentucky, 40205-1016, United States

Location

Related Publications (3)

• 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: 24691784 BACKGROUND

• 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: 24488838 BACKGROUND

• 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: 20127936 BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa

Interventions

Implosive Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

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

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: May 2, 2019
• Study Start: May 1, 2017
• Primary Completion: December 13, 2020
• Study Completion: October 1, 2022
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)