Clinical trial NCT03747835: Meal-Based Exposure and Response Prevention in Anorexia Nervosa
Official title: Meal-Based Exposure and Response Prevention in Anorexia Nervosa: Reducing Physiological and Self-reported Food-Related Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: The Hilda and Preston Davis Foundation
First posted: 2018-11-20
Enrollment: 27
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Meets Diagnostic and Statistical Manual of Mental Disorders (DSM) -5 criteria for AN or Other Specified Feeding and Eating Disorder.
* Body Mass Index (BMI) \> 14.0 kg/m2 and \< 20.0 kg/m2
* Age \> 12 years, \< 66 years
* Fluency in the English language

Exclusion criteria:

* Diagnosis of schizophrenia, schizophreniform disorder, bipolar illness (type I) with active psychotic symptoms
* History of traumatic brain injury with current impairment in functioning
* Current use of benzodiazepines, as these medications may alter psychophysiological assessment
* Allergy to dairy products or chocolate contained in the test meal

Primary outcomes:
measure: Change in Physiological Anxiety in Response to Food Images as assessed by Skin Conductance Response
timeFrame: Pre-treatment and post-treatment up to 10 weeks
measure: Change in Physiological Anxiety in Response to Food Images as assessed by Heart rate variability
timeFrame: Pre-treatment and post-treatment up to 10 weeks
measure: Change in amount of high calorie diet consumption
timeFrame: At week 2 of treatment and at discharge, up to 10 weeks
Secondary outcomes:
measure: Change in food related anxiety as assessed by the Food Anxiety Questionnaire.
timeFrame: Weekly up to 10 weeks
measure: Change in food Choice Preferences as assessed by The Food Choice Task
timeFrame: Pre-treatment and post-treatment up to 10 weeks
measure: Eating Disorder Examination Questionnaire Scores
timeFrame: Pre-treatment and post-treatment up to 10 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Colleen C Schreyer, PhD
role: PRINCIPAL_INVESTIGATOR
References: