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NCT03747835 · ClinicalTrials.gov registry record · NA
Meal-Based Exposure and Response Prevention in Anorexia Nervosa
A NA study of Anorexia Nervosa, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT03747835: Completed NA study of Anorexia Nervosa, sponsored by Johns Hopkins University.
NCT03747835 is a NA study of Anorexia Nervosa that has completed, run by Johns Hopkins University. The registered enrollment target is 27 participants, below the 950-participant average among 43 other Anorexia Nervosa trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03747835, a NA study of Anorexia Nervosa, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with anorexia nervosa (AN), a serious psychiatric disorder, exhibit restricted dietary intake and endorse fear of consuming calorie-dense foods, which in turn drives weight loss. Premorbid anxious personality traits and comorbid anxiety disorders are common in patients with AN. Although intensive behavioral treatment programs can achieve weight restoration in a majority of adults with AN, relapse rates are high. Predictors of relapse include elevated state anxiety and low dietary variety, including lower intake of fat, after discharge, which suggests that relapse following weight restoration may be related to inadequate fear extinction to high energy density (ED) foods during treatment and consequent resumption of restrictive eating patterns. Despite evidence of anxiety's role in the onset and maintenance of restricted eating behavior, utilizing exposure and response prevention (EX-RP) and meal-based interventions to reduce food-related fears is understudied. EX-RP is the gold standard of treatment for Obsessive Compulsive Disorder (OCD). This proposal aims to test the efficacy of an adjunct meal-based EX-RP intervention to reduce food-related fears during intensive behavioral weight restoration in hospitalized patients with AN in comparison to a control treatment, Motivational Interviewing. The investigators will assess changes in a) self-reported anxiety regarding consumption of high-ED foods, b) physiological (skin conductance and heart rate variability) responses to imagined consumption of food items elicited utilizing a visual food cue task, and c) caloric intake of a challenging test meal pre- and post-treatment. A secondary aim is to assess the relationship of early treatment response to EX-RP, operationalized as a reduction in self-reported anxiety within the first three weeks of treatment, and end-of-treatment as well as six-month post-discharge outcomes. Helping patients tolerate food-related anxiety and increase dietary variety across meal contex
Conditions Studied
Interventions
- BEHAVIORAL Motivational Interviewing
- BEHAVIORAL Exposure and Response Prevention
Study Locations (1)
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2021-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03747835
The ClinicalTrials.gov registry entry for NCT03747835 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 950-participant average among 43 other Anorexia Nervosa trials with a reported enrollment target (97% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Anorexia Nervosa appearing as the primary indexed condition, and to 2 interventions - of which Motivational Interviewing is the first listed.
NCT03747835 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03747835 about?
NCT03747835 is a clinical study titled "Meal-Based Exposure and Response Prevention in Anorexia Nervosa". Patients with anorexia nervosa (AN), a serious psychiatric disorder, exhibit restricted dietary intake and endorse fear of consuming calorie-dense foods, which in turn drives weight loss. Premorbid anxious personality traits and comorbid anxiety disorders are common in patients with AN. Although int...
What is the current status of trial NCT03747835?
This trial is currently completed. It is a NA study. The enrollment target is 27 participants. The study started on 2018-11-01. Estimated completion is 2021-12-31.
What conditions does trial NCT03747835 study?
This clinical trial studies the following conditions: Anorexia Nervosa.
What interventions are being tested in trial NCT03747835?
The interventions under investigation include: Motivational Interviewing (BEHAVIORAL), Exposure and Response Prevention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03747835?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03747835 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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