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Completed

NCT Number: NCT03934697

Imaginal Exposure II Study: In-Vivo

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

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Key information

Conditions

Eating Disorder Anorexia Nervosa Bulimia Nervosa Exposure Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eating Anxiety Treatment Laboratory and Clinic

Louisville, Kentucky, 40205-1016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Exposure Therapy

Primary outcomes

  1. 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?).

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

In-Vivo Treatment for Imaginal Exposure Therapy

Acronym: In-vivo IE II

Important dates

Study start
2017
Primary completion
2020
Study completion
2022
First posted
May 2, 2019
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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