Meal-Based Exposure and Response Prevention in Anorexia Nervosa
Primary Purpose
Anorexia Nervosa
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exposure and Response Prevention
Motivational Interviewing
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa
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
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Exposure and Response Prevention
Motivational Interviewing
Arm Description
Inpatients will be provided three 90-minute sessions of Exposure and Response Prevention therapy each week.
Inpatients will be provided two 60-minute sessions of Motivational Interviewing each week.
Outcomes
Primary Outcome Measures
Change in Physiological Anxiety in Response to Food Images as assessed by Skin Conductance Response
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
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.
Change in amount of high calorie diet consumption
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.
Secondary Outcome Measures
Change in food related anxiety as assessed by the Food Anxiety Questionnaire.
Patients will complete the Food Anxiety Questionnaire, which asks patients to rate their anxiety regarding consumption of 35 frequently consumed foods, using Subjective Units of Distress. Subjective Units of Distress range from 0-100, with '0' indicating no distress or anxiety and '100' indicating the highest possible level of distress or anxiety.
Change in food Choice Preferences as assessed by The Food Choice Task
The Food Choice Task is a computer based task that assesses preference for low- versus high-fat food items. Patients rate food items on tastiness and healthiness and are then asked to make a series of choices regarding food preferences. The proportion of high-fat food choices made is an indication of the patient's preference for low-versus high-fat foods. A higher proportion of trials on which individuals select the high-fat food is associated with an increased willingness to consume those foods.
Eating Disorder Examination Questionnaire Scores
Patients will complete the 28-item Eating Disorder Examination Questionnaire, which includes four subscales: Eating Concern, Weight Concern, Restraint, and Shape Concern. Scores on these subscales range from 0 to 7, with higher scores indicative of more pathology.
Full Information
NCT ID
NCT03747835
First Posted
November 14, 2018
Last Updated
February 1, 2022
Sponsor
Johns Hopkins University
Collaborators
The Hilda and Preston Davis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03747835
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
The Hilda and Preston Davis Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exposure and Response Prevention
Arm Type
Active Comparator
Arm Description
Inpatients will be provided three 90-minute sessions of Exposure and Response Prevention therapy each week.
Arm Title
Motivational Interviewing
Arm Type
Active Comparator
Arm Description
Inpatients will be provided two 60-minute sessions of Motivational Interviewing each week.
Intervention Type
Behavioral
Intervention Name(s)
Exposure and Response Prevention
Intervention Description
Exposure 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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
Motivational 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.
Primary Outcome Measure Information:
Title
Change in Physiological Anxiety in Response to Food Images as assessed by Skin Conductance Response
Description
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.
Time Frame
Pre-treatment and post-treatment up to 10 weeks
Title
Change in Physiological Anxiety in Response to Food Images as assessed by Heart rate variability
Description
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.
Time Frame
Pre-treatment and post-treatment up to 10 weeks
Title
Change in amount of high calorie diet consumption
Description
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.
Time Frame
At week 2 of treatment and at discharge, up to 10 weeks
Secondary Outcome Measure Information:
Title
Change in food related anxiety as assessed by the Food Anxiety Questionnaire.
Description
Patients will complete the Food Anxiety Questionnaire, which asks patients to rate their anxiety regarding consumption of 35 frequently consumed foods, using Subjective Units of Distress. Subjective Units of Distress range from 0-100, with '0' indicating no distress or anxiety and '100' indicating the highest possible level of distress or anxiety.
Time Frame
Weekly up to 10 weeks
Title
Change in food Choice Preferences as assessed by The Food Choice Task
Description
The Food Choice Task is a computer based task that assesses preference for low- versus high-fat food items. Patients rate food items on tastiness and healthiness and are then asked to make a series of choices regarding food preferences. The proportion of high-fat food choices made is an indication of the patient's preference for low-versus high-fat foods. A higher proportion of trials on which individuals select the high-fat food is associated with an increased willingness to consume those foods.
Time Frame
Pre-treatment and post-treatment up to 10 weeks
Title
Eating Disorder Examination Questionnaire Scores
Description
Patients will complete the 28-item Eating Disorder Examination Questionnaire, which includes four subscales: Eating Concern, Weight Concern, Restraint, and Shape Concern. Scores on these subscales range from 0 to 7, with higher scores indicative of more pathology.
Time Frame
Pre-treatment and post-treatment up to 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen C Schreyer, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Meal-Based Exposure and Response Prevention in Anorexia Nervosa
We'll reach out to this number within 24 hrs