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Trial record 24 of 126 for:    Recruiting, Not yet recruiting, Available Studies | "Eating Disorders"

Reward Systems and Food Avoidance in Eating Disorders

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ClinicalTrials.gov Identifier: NCT02795455
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : October 24, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Low Weight Eating Disorders Anorexia Nervosa Behavioral: Interoceptive Exposure (IE) Behavioral: Family Based Therapy-Weight Gain Control (FBT-WG) Dietary Supplement: meal replacement shake Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reward Systems and Food Avoidance in Adolescents With Low Weight Eating Disorders
Study Start Date : November 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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.
Behavioral: Interoceptive Exposure (IE)
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.

Dietary Supplement: meal replacement shake
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.
Behavioral: Family Based Therapy-Weight Gain Control (FBT-WG)
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.

No Intervention: Healthy Controls (HC)
HC participants will only participate in the pre and post-intervention visits and not in the intervention sessions.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Anxiety Sensitivity Index-III [ Time Frame: Baseline and 6 weeks ]
    Change in index at 6 weeks as compared to baseline. Self-reported anxiety symptomology



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795455


Contacts
Contact: Tom Hildebrandt, PsyD 212-659-8673 tom.hildebrandt@mssm.edu
Contact: Robyn Sysko, PhD 212-659-8724 robyn.sysko@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Tom Hildebrandt, PsyD    212-659-8673    tom.hildebrandt@mssm.edu   
Principal Investigator: Tom Hildebrandt, PsyD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Tom Hildebrandt, PsyD Icahn School of Medicine at Mount Sinai

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02795455     History of Changes
Other Study ID Numbers: GCO 15-0939
1R01MH109639-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
Eating Disorders
Food Avoidance
Reward Learning
Reward System
Family-based treatment
interoceptive exposure
insula-amygdala-ventral striatum subcircuits

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Anorexia
Anorexia Nervosa
Pathologic Processes
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms