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Clinical Trials/NCT03747835
NCT03747835
Completed
Not Applicable

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

Johns Hopkins University1 site in 1 country27 target enrollmentNovember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anorexia Nervosa
Sponsor
Johns Hopkins University
Enrollment
27
Locations
1
Primary Endpoint
Change in amount of high calorie diet consumption
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in amount of high calorie diet consumption

Time Frame: At week 2 of treatment and at discharge, up to 10 weeks

Patients will be asked to consume a meal (1,066 kcal) consisting of calorie dense foods over a period of 45 minutes. Total caloric intake will be measured by weighing food items prior to and following the meal and identifying the proportion of the meal in kcal consumed.

Change in Physiological Anxiety in Response to Food Images as assessed by Skin Conductance Response

Time Frame: Pre-treatment and post-treatment up to 10 weeks

Participants will view images of low- and high-ED foods, and of office products for 8 seconds each. Skin Conductance Response (microsiemens) will be recorded from electrodes placed on the palmar surface of the middle phalanges of the 2nd and 3rd fingers on the non-dominant hand.

Change in Physiological Anxiety in Response to Food Images as assessed by Heart rate variability

Time Frame: Pre-treatment and post-treatment up to 10 weeks

Participants will view images of low- and high-ED foods, and of office products for 8 seconds each. Heart rate variability will be measured using ECG electrodes placed in a diagonal axis across the heart region, with a reference electrode on the stomach.

Secondary Outcomes

  • Change in food Choice Preferences as assessed by The Food Choice Task(Pre-treatment and post-treatment up to 10 weeks)
  • Eating Disorder Examination Questionnaire Scores(Pre-treatment and post-treatment up to 10 weeks)
  • Change in food related anxiety as assessed by the Food Anxiety Questionnaire.(Weekly up to 10 weeks)

Study Sites (1)

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