Reward Systems and Food Avoidance in Eating Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02795455|
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : October 11, 2018
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- Anxiety Sensitivity Index-III [ Time Frame: Baseline and 6 weeks ]Change in index at 6 weeks as compared to baseline. Self-reported anxiety symptomology
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
|Contact: Tom Hildebrandt, PsyDfirstname.lastname@example.org|
|Contact: Robyn Sysko, PhDemail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Tom Hildebrandt, PsyD|
|Principal Investigator:||Tom Hildebrandt, PsyD||Icahn School of Medicine at Mount Sinai|