- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02795455
Reward Systems and Food Avoidance in Eating Disorders
August 4, 2021 updated by: Tom Hildebrandt, Icahn School of Medicine at Mount Sinai
Reward Systems and Food Avoidance in Adolescents With Low Weight Eating Disorders
The researchers plan to explore brain networks involved in emotion processing and learning using a brain scan and test meals.
One core feature of Anorexia Nervosa (AN) is eating a small number of high-calorie or high-fat foods.
By studying why individuals with AN are disgusted by food or other eating situations, the researchers will be able to understand more about the neurobiological pathways that lead to restricting food intake and food avoidance.
This study also aims to find whether one of two short-term interventions (Interoceptive Exposure (IE); Family-Based Therapy (FBT)) affects connections in the brain and if the treatments affect food avoidance.
IE is an intervention that helps reduce anxiety about eating.
FBT is an intervention that motivates patients to eat through working with family to increase the value of eating and decrease the value of avoiding foods.
Study Overview
Status
Completed
Conditions
Detailed Description
Anorexia nervosa (AN), a characteristically relentless pursuit of thinness with an intense fear of weight gain despite significantly low body weight, is a serious psychiatric disorder with high rates of morbidity and mortality.
Low weight eating disorders (LW-ED), the broader category of eating pathology that includes AN and similar variants, are characterized by a chronic course, poor response to treatment, and food avoidance.
Emerging neuroimaging evidence suggests that deficits in insula-amygdala-ventral striatum (IAVS) neurocircuitry contribute to individual variability in aversive and reward learning, and that these brain regions demonstrate abnormal responses to food/eating stimuli.
The researchers' pilot data suggest that patients with LW-ED experience difficulty extinguishing food-cue associations in a reversal learning paradigm compared to healthy controls, a difficulty that is related to psychophysiological measures of aversive disgust (not fear).
The researchers have also successfully piloted an interoceptive exposure intervention for this population that targets visceral sensitivity and seeks to increase 'top-down' regulation of the IAVS neurocircuit.
The proposed project will (a) use novel fMRI-EMG to test the relationship between effective connectivity within amygdala-insula-ventral striatum network and its relationship to psychophysiological and behavioral measures of acute threat and reward learning in 60 adolescents with LWEDs and 30 healthy controls, (b) test the sensitivity of this network to an experimental interoceptive exposure paradigm relative to patients receiving family based therapy for weight restoration using dynamic causal modeling of fMRI-EMG data pre-post experimental conditions, (c) validate this model against objective measures of laboratory and real world eating behavior.
The results of this study will help better understand the core neurocircuitry that underlies both threat processing and reward/aversive learning and how this circuit relates to objective behavior.
Further, the researchers will determine the modifiability of this neurocircuitry via two distinct behavioral interventions chosen to target different aspects of affective processing and reward learning.
These data will be used to inform future clinical interventions targeting aversive/reward learning within this population and dysregulation in insula-amygdala-ventral striatum subcircuits.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Low Weight ED Patients
Inclusion criteria:
- Females,
- Adolescents ages 12-18,
- Speak English,
- Seeking treatment
- Refusal to maintain greater than minimally low body weight based on BMI for age percentiles and growth trajectories,
- Clinically significant restriction of food intake on the dietary restraint subscale of the EDE or evidence of persistent food avoidance as reported by patient or guardians.
- Given medical clearance from pediatrician or equivalent.
Exclusion criteria:
- Current psychotropic medication that would have an effect on performance on behavioral tasks (i.e., anti-anxiety medication),
- Comorbid psychotic or bipolar disorder,
- Active suicidal ideation,
- Major medical illness known to influence eating or weight,
- Current substance dependence,
- Previous exposure therapy for LW-ED.
- Physical limitation that would prevent participation (e.g., allergic to chocolate),
- For patients with current or a history of sexual or physical abuse by parents, siblings, or guardians, perpetrators of the abuse will be excluded from treatment; if physical or sexual abuse by a family member occurs during the course of treatment, perpetrators will be excluded from ongoing treatment
Healthy Comparison Adolescents
Inclusion criteria:
- Females,
- Adolescents ages 12-18,
- Speak English.
Exclusion criteria:
- Current psychotropic medication that would have an effect on performance on behavioral tasks (i.e., stimulant medication),
- Current or lifetime history of any psychiatric disorder, including eating disorders by K-SADS,
- Current or lifetime history of learning disorder or developmental disability
- Active suicidal ideation,
- Major medical illness,
- Other physical limitation that would prevent participation (e.g., allergic to chocolate).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interoceptive Exposure (IE)
IE is an exposure-based intervention that involves consuming a food in session and tolerating uncomfortable feelings around eating.
|
Participants are provided with a meal replacement shake of 'unknown' Kcal or macronutrient content and are asked to mindfully observe the sensations (aversive taste, texture, bloating, icky feeling, etc.) and associated emotional states (i.e., disgust) with the empathetic support of parents/therapist in session, without expectation of habituation.
Sessions occur on a weekly basis with session one lasting 2 hrs.
The remaining 5 sessions last one hour, and participants eat a meal replacement shake over 30-minutes, identical to the first session.
All sessions include debriefing and development of IE homework that includes daily practice of IE.
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Active Comparator: Family Based Therapy-Weight Gain Control (FBT-WG)
Family-based therapy uses parent(s) to help modify disordered eating and develop contingencies to motivate eating.
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Participants and families randomized to FBT-WG will receive 6-weeks of FBT treatment for AN.
Sessions occur weekly, with the first session lasting two hours and the remaining 5 sessions one hour.
FBT is atheoretical in terms of the etiology, but uses parent-enforced contingencies to increase value of eating and decrease the value of food avoidance.
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No Intervention: Healthy Controls (HC)
HC participants will only participate in the pre and post-intervention visits and not in the intervention sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fMRI-EMG
Time Frame: Baseline and 6 weeks
|
Change in the emotional responses from facial muscle movements to food pictures and non-food pictures as measured with the fMRI-EMG.
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Baseline and 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
KCal Intake
Time Frame: Baseline and 6 weeks
|
Change in KCal Intake at 6 weeks as compared to baseline.
Consumption of a standardized strawberry yogurt shake test meal will be measured in kcal.
Participants will be presented with an 83 fluid ounce (2454.60-mL)
covered opaque container containing approximately 1500 grams (1.04 kcal per gram, or approximately 1560 kcal) of strawberry yogurt shake.
Patients will be informed that the meal consists of a strawberry yogurt shake, but will not be told the amount provided in the container.
The instructions will direct participants to consume as much of the shake as they would like and that the meal will serve as their lunch (or dinner) for the day and to avoid touching or manipulating the container in any way.
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Baseline and 6 weeks
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Eating Disorder Examination (EDE)
Time Frame: Baseline and 6 weeks
|
Change in EDE at 6 weeks as compared to baseline.
Clinical interview to assess for eating disorder symptomology.
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Baseline and 6 weeks
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Clinical Impairment Assessment
Time Frame: Baseline and 6 weeks
|
Change in assessment at 6 weeks as compared to baseline.
The Clinical Impairment Assessment (CIA) is a 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features on the past 28 days.
Each item are scored 0, 1, 2, 3 with a higher rating indicating a higher level of impairment, with total score ranging from 0 to 48 with a higher score being indicative of a higher level of psychosocial impairment secondary to eating disorder features.
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Baseline and 6 weeks
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Anxiety Sensitivity Index-III
Time Frame: Baseline and 6 weeks
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Change in index at 6 weeks as compared to baseline.
Self-reported anxiety symptomology
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Baseline and 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Tom Hildebrandt, PsyD, Icahn School of Medicine at Mount Sinai
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
July 29, 2021
Study Completion (Actual)
July 29, 2021
Study Registration Dates
First Submitted
May 19, 2016
First Submitted That Met QC Criteria
June 6, 2016
First Posted (Estimate)
June 10, 2016
Study Record Updates
Last Update Posted (Actual)
August 6, 2021
Last Update Submitted That Met QC Criteria
August 4, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 15-0939
- 1R01MH109639-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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