Back to resultsImaginal Exposure II Study: In-Vivo (In-vivo IE II)
Primary Purpose
Eating Disorder, Anorexia Nervosa, Bulimia Nervosa
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
imaginal exposure therapy
Sponsored by
About this trial
This is an interventional treatment trial for Eating Disorder focused on measuring Eating Disorder, Anorexia Nervosa, Bulimia Nervosa, Imaginal Exposure Therapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Eating Anxiety Treatment Laboratory and Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Imaginal Exposure Session
Arm Description
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.
Outcomes
Primary Outcome Measures
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?).
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03934697
First Posted
October 16, 2018
Last Updated
March 10, 2023
Sponsor
University of Louisville
1. Study Identification
Unique Protocol Identification Number
NCT03934697
Brief Title
Imaginal Exposure II Study: In-Vivo
Acronym
In-vivo IE II
Official Title
In-Vivo Treatment for Imaginal Exposure Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
December 13, 2020 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test if imaginal exposure therapy can decrease symptoms of eating disorders and anxiety.
Detailed Description
An initial meeting consisting of a screening, questionnaires, and a brief psychoeducation on imaginal exposure therapy, followed by 8-10 sessions with a licensed psychologist (the PI) or a clinical psychology graduate student who is supervised and trained by the PI. In Session 1, patients will create a script with the therapist on an eating disorder fear. In sessions 2-10 the therapist and patient will then imagine this eating disorder related fear based on the script. Each session will be modified to focus on "hot spots" or the most feared aspect of the script. Sessions will be audiotaped and videotaped and participants will be asked to listen to the sessions nightly for homework. Sessions will be weekly or twice per week for 8-10 weeks after the initial screening session.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder, Anorexia Nervosa, Bulimia Nervosa, Exposure
Keywords
Eating Disorder, Anorexia Nervosa, Bulimia Nervosa, Imaginal Exposure Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Imaginal Exposure Session
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
imaginal exposure therapy
Other Intervention Name(s)
Exposure Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
EDEQ (Eating Disorder Examination Questionnaire) at 1-10 Weeks and at 1 year
Description
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?).
Time Frame
1 year and 10 weeks
Title
SUDS (Subjective Units of Distress Scale) at 1-10 Weeks and at 1 year
Description
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.
Time Frame
1 year and 10 weeks
Title
Body Mass Index (BMI) at 1-10 Weeks and at 1 year
Description
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.
Time Frame
1 year and 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
Eating Anxiety Treatment Laboratory and Clinic
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205-1016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24691784
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.
Results Reference
background
PubMed Identifier
24488838
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.
Results Reference
background
PubMed Identifier
20127936
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.
Results Reference
background
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Imaginal Exposure II Study: In-Vivo
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