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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

Imaginal Exposure II Study: In-Vivo

Clinicaltrials.gov identifier NCT03934697

Recruitment Status Recruiting

First Posted May 2, 2019

Last update posted May 2, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Eating Disorder
    Anorexia Nervosa
    Bulimia Nervosa
    Exposure
  • Intervention/Treatment: Behavioral: imaginal exposure therapy
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 50 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: In-Vivo Treatment for Imaginal Exposure Therapy
  • Actual Study Start Date: May 2017
  • Estimated Primary Completion Date: June 2020
  • Estimated Study Completion Date: June 2021
Arms and interventions
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.
Outcome Measures
  • Primary Outcome Measures: 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts

Contact: Cheri A Levinson 502-852-7710 cheri.levinson@louisville.edu

Locations

United States, Kentucky
Eating Anxiety Treatment Laboratory and Clinic
Louisville

Sponsors and Collaborators

University of Louisville

More Information