Imaginal Exposure II Study: In-Vivo (In-vivo IE II)

March 1, 2024 updated by: Cheri Levinson, University of Louisville

In-Vivo Treatment for Imaginal Exposure Therapy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40205-1016
        • Eating Anxiety Treatment Laboratory and Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Imaginal Exposure Session
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
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.
Other Names:
  • Exposure Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EDEQ (Eating Disorder Examination Questionnaire) at 1-10 Weeks and at 1 year
Time Frame: 1 year and 10 weeks
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
Time Frame: 1 year and 10 weeks
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
Time Frame: 1 year and 10 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

December 13, 2020

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

October 16, 2018

First Submitted That Met QC Criteria

April 30, 2019

First Posted (Actual)

May 2, 2019

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#:16.1003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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