Clinical Trials Directory

Trials / Completed

CompletedNCT03747835

Meal-Based Exposure and Response Prevention in Anorexia Nervosa

Meal-Based Exposure and Response Prevention in Anorexia Nervosa: Reducing Physiological and Self-reported Food-Related Anxiety

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
27 (actual)
Sponsor
Johns Hopkins University · Academic / Other
Sex
All
Age
13 Years – 65 Years
Healthy volunteers
Not accepted

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 contexts may augment treatment effectiveness in adult patients during intensive treatment for AN and has potential to decrease relapse rates.

Conditions

Interventions

TypeNameDescription
BEHAVIORALExposure and Response PreventionExposure and Response Prevention involves collaboratively developing a list of food-related fears with the patient and planning treatment sessions in which the patient is exposed to the fear and inhibits safety behaviors. The explicit goal of these exposure sessions will be to violate the patient's expectation regarding the feared stimulus, rather than to reduce fear.
BEHAVIORALMotivational InterviewingMotivational interviewing techniques including reflective listening to demonstrate empathy and understanding, asking questions to elicit change talk (speech that is "pro-change"), evaluating the decisional balance, and managing or "rolling with" resistance will be incorporated throughout the treatment sessions.

Timeline

Start date
2018-11-01
Primary completion
2021-12-31
Completion
2021-12-31
First posted
2018-11-20
Last updated
2022-02-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03747835. Inclusion in this directory is not an endorsement.