Meal-Based Exposure and Response Prevention in Anorexia Nervosa

NCT03747835 | Completed

• 1 other identifier: IRB00174855
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (3)

• 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.

  Pre-treatment and post-treatment up to 10 weeks

• 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.

  Pre-treatment and post-treatment up to 10 weeks

• 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.

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

Secondary Outcomes (3)

• Change in food related anxiety as assessed by the Food Anxiety Questionnaire.

  Weekly up to 10 weeks

• 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

Study Arms (2)

Exposure and Response Prevention

ACTIVE COMPARATOR

Inpatients will be provided three 90-minute sessions of Exposure and Response Prevention therapy each week.

Behavioral: Exposure and Response Prevention

Motivational Interviewing

ACTIVE COMPARATOR

Inpatients will be provided two 60-minute sessions of Motivational Interviewing each week.

Behavioral: Motivational Interviewing

Interventions

Exposure and Response Prevention BEHAVIORAL

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.

Exposure and Response Prevention

Motivational Interviewing BEHAVIORAL

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.

Motivational Interviewing

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• The Hilda and Preston Davis Foundation: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Colleen C Schreyer, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 20, 2018
• Study Start: November 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 2, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)