Meal-Based Exposure and Response Prevention in Anorexia Nervosa
Public ClinicalTrials.gov record NCT03747835. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Meal-Based Exposure and Response Prevention in Anorexia Nervosa: Reducing Physiological and Self-reported Food-Related Anxiety
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 contexts may augment treatment effectiveness in adult patients during intensive treatment for AN and has potential to decrease relapse rates.
Study identification
- NCT ID
- NCT03747835
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 27 participants
Conditions and interventions
Conditions
Interventions
- Exposure and Response Prevention Behavioral
- Motivational Interviewing Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 13 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2018
- Primary completion
- Dec 30, 2021
- Completion
- Dec 30, 2021
- Last update posted
- Feb 1, 2022
2018 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03747835, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 1, 2022 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03747835 live on ClinicalTrials.gov.