Reward Systems and Food Avoidance in Eating Disorders
2 other identifiers
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2016
CompletedFirst Posted
Study publicly available on registry
June 10, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2021
CompletedMay 7, 2025
May 1, 2025
4.7 years
May 19, 2016
May 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
fMRI-EMG
Change in the emotional responses from facial muscle movements to food pictures and non-food pictures as measured with the fMRI-EMG.
Baseline and 6 weeks
Secondary Outcomes (4)
KCal Intake
Baseline and 6 weeks
Eating Disorder Examination (EDE)
Baseline and 6 weeks
Clinical Impairment Assessment
Baseline and 6 weeks
Anxiety Sensitivity Index-III
Baseline and 6 weeks
Study Arms (3)
Interoceptive Exposure (IE)
EXPERIMENTALIE is an exposure-based intervention that involves consuming a food in session and tolerating uncomfortable feelings around eating.
Family Based Therapy-Weight Gain Control (FBT-WG)
ACTIVE COMPARATORFamily-based therapy uses parent(s) to help modify disordered eating and develop contingencies to motivate eating.
Healthy Controls (HC)
NO INTERVENTIONHC participants will only participate in the pre and post-intervention visits and not in the intervention sessions.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- Females,
- Adolescents ages 12-18,
- Speak English.
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Related Publications (2)
Schulz KP, Sysko R, Fan J, Hildebrandt TB. Interoceptive Exposure Impacts Food-Cue Extinction in Adolescents With Low-Weight Eating Disorders: A Functional Magnetic Resonance Imaging Study. J Am Acad Child Adolesc Psychiatry. 2026 Jan;65(1):66-75. doi: 10.1016/j.jaac.2024.12.013. Epub 2025 Feb 25.
PMID: 40015474BACKGROUNDHildebrandt T, Schulz K, Fleysher L, Griffen T, Heywood A, Sysko R. Development of a methodology to combine fMRI and EMG to measure emotional responses in patients with anorexia nervosa. Int J Eat Disord. 2018 Jul;51(7):722-729. doi: 10.1002/eat.22893. Epub 2018 Aug 18.
PMID: 30120839DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tom Hildebrandt, PsyD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor - Psychiatry
Study Record Dates
First Submitted
May 19, 2016
First Posted
June 10, 2016
Study Start
November 1, 2016
Primary Completion
July 29, 2021
Study Completion
July 29, 2021
Last Updated
May 7, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share