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Interoceptive Exposure for Adolescents With Low Weight Eating Disorders

Primary Purpose

Anorexia Nervosa

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interoceptive Exposure Treatment (IE)
Family-Based Treatment (FBT)
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 12-18 Speak English Permission from pediatrician or equivalent to receive outpatient care Clinically significant restriction of food intake by EDA-5 or evidence of persistent food avoidance from patient or guardians Evidence of the inability to maintain greater than minimally low body weight based on BMI for age percentiles and growth trajectories Exclusion Criteria: Comorbid psychotic or bipolar disorder Active suicidal ideation Current substance dependence Psychiatric medication initiated or dosage changes <2 weeks from baseline Major medical illness (e.g., diabetes mellitus, Crohn's disease, etc.)

Sites / Locations

  • Department of Psychiatry, Eating and Weight Disorders ProgramRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interoceptive Exposure Treatment (IE)

Family-Based Treatment (FBT)

Arm Description

Interoceptive Exposure Therapy (IE) targets food avoidance, food exposure, and body image exposure.

Family-Based Therapy (FBT) focuses on parent-enforced contingencies, increasing value of eating, and decreasing the value of food avoidance.

Outcomes

Primary Outcome Measures

Change in Expected Body Weight Percentage
Expected body weight percentage will be calculated at baseline and end of treatment (6-months) to calculate difference.
Change in Expected Body Weight Percentage
Expected body weight percentage will be calculated at baseline and 1 year after treatment (18-months) to calculate difference.
Change in Impairment
Impairment is measured using the Clinical Impairment Assessment, which is a 16-item self-report measure of impairment from eating disorders. Responses are scored using 0, 1, 2, or 3 and the score is calculated using the sum of all items. Possible scores range between 0 - 48, with higher scores indicating more impairment and lower scores indicating less impairment. Change in impairment will be calculated using the baseline and end of treatment (6-months) scores from CIA.
Change in Impairment
Impairment is measured using the Clinical Impairment Assessment, which is a 16-item self-report measure of impairment from eating disorders. Responses are scored using 0, 1, 2, or 3 and the score is calculated using the sum of all items. Possible scores range between 0 - 48, with higher scores indicating more impairment and lower scores indicating less impairment. Change in impairment will be calculated using the baseline and 1 year after treatment (18-months) scores from CIA.

Secondary Outcome Measures

Change in Autonomous Eating
Autonomous eating will be measured in total calories consumed during a single-item meal. Change in total calories consumed will be calculated between baseline and end of treatment (6-months).
Change in Autonomous Eating
Autonomous eating will be measured in total calories consumed during a single-item meal. Change in total calories consumed will be calculated between baseline and 1 year after treatment (18-months).
Change in Food Cue Learning
Food cue learning is a task completed on a computer that tests associations between food and level of disgust. Pictures of food are shown including fresh and rotten versions of each and participants then rate on a scale from yucky to yummy for each. These ratings produce an extinction rate. There is no set range for scoring, however lower rates indicate more impairment and higher rates indicate less impairment. Extinction rate will be calculated between baseline and end of treatment (6-months).
Change in Food Cue Learning
Food cue learning is a task completed on a computer that tests associations between food and level of disgust. Pictures of food are shown including fresh and rotten versions of each and participants then rate on a scale from yucky to yummy for each. These ratings produce an extinction rate. There is no set range for scoring, however lower rates indicate more impairment and higher rates indicate less impairment. Extinction rate will be calculated between baseline and 1 year after treatment (18-months).
Change in Eating Disorder Symptoms
Youth Eating Disorder Questionnaire (Y-EDE-Q) is a self-report measure assessing psychopathology of eating disorders in youth using 39 items. Global scores range from 0 to 6 with higher scores indicating symptoms of higher severity. Scores will be calculated between baseline and end of treatment (6-months).
Change in Eating Disorder Symptoms
Youth Eating Disorder Questionnaire (Y-EDE-Q) is a self-report measure assessing psychopathology of eating disorders in youth using 39 items. Global scores range from 0 to 6 with higher scores indicating symptoms of higher severity. Scores will be calculated between baseline and end of treatment (6-months).
Change in Nonjudgmental Body Awareness
Body awareness Questionnaire (BAQ) is a self-report measure assessing awareness of body sensitivity and changes using 18 items on a score range of 18-126. Higher scores indicate more awareness of body regulation. Scores will be calculated between baseline and end of treatment (6-months).
Change in Nonjudgmental Body Awareness
Body awareness Questionnaire (BAQ) is a self-report measure assessing awareness of body sensitivity and changes using 18 items on a score range of 18-126. Higher scores indicate more awareness of body regulation. Scores will be calculated between baseline and end of treatment (18-months).

Full Information

First Posted
February 28, 2023
Last Updated
June 12, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05763849
Brief Title
Interoceptive Exposure for Adolescents With Low Weight Eating Disorders
Official Title
A Confirmatory Efficacy Study of Interoceptive Exposure for Adolescents With Low Weight Eating Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
January 31, 2028 (Anticipated)
Study Completion Date
January 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This project includes a parallel group randomized controlled trial comparing two psychological treatments: 1) Exposure-based Family Therapy (IE) vs. 2) Family Based Therapy (FBT) for low weight eating disorders with 12 month follow-up. Primary outcomes are expected body weight and clinical impairment. Three mechanisms of change (Autonomous Eating, Non-Judgmental Body Awareness, and Extinction Learning) will be examined in a process mediation models of change.
Detailed Description
A total of 120 individuals with Anorexia Nervosa ages 12-18 will be enrolled to either 20 sessions of outpatient Exposure-based Family Therapy (IE) or Family Based Therapy (FBT). The aims of the study are to test the comparative efficacy and primary mechanisms of change after 6 months of treatment and at one year post-treatment and to explore the mediators and moderators of the primary outcomes at these endpoints. All recruitment and study procedures will take place through the Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai. Assessments will take place at 2-, 4-, 6-, 12-, and 18-months following baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This RCT includes a parallel group design including two psychological treatments (Exposure-based Family Therapy vs. Family Based Therapy) for low weight eating disorders with 12 month follow-up.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interoceptive Exposure Treatment (IE)
Arm Type
Experimental
Arm Description
Interoceptive Exposure Therapy (IE) targets food avoidance, food exposure, and body image exposure.
Arm Title
Family-Based Treatment (FBT)
Arm Type
Active Comparator
Arm Description
Family-Based Therapy (FBT) focuses on parent-enforced contingencies, increasing value of eating, and decreasing the value of food avoidance.
Intervention Type
Behavioral
Intervention Name(s)
Interoceptive Exposure Treatment (IE)
Intervention Description
Interoceptive Exposure Therapy (IE) targets food avoidance in Anorexia Nervosa. Each session the therapist weighs the patient, checks-in, and reviews weekly homework. Sessions occur weekly for 20 weeks, with the first session lasting 1.5 hours and the remaining sessions one hour. Early sessions include using exposure to foods and counterconditioning to pair a positive stimulus with a food that would typically produce food avoidance. Parents are trained to model this at home. Sessions mid-way through address the use of non-judgmental description of appearance during mirror exposure. Sessions at the end of the 20 weeks are focused on recognizing change, planning for future obstacles, and developing a relapse prevention plan to continue practicing distress tolerance, counter-conditioning, and food/body exposure.
Intervention Type
Behavioral
Intervention Name(s)
Family-Based Treatment (FBT)
Intervention Description
Family-Based Therapy (FBT) includes parent-enforced contingencies to increase value of eating and decrease the value of food avoidance. Each session the therapist weighs the patient, checks-in, and reviews weekly homework. Sessions occur weekly for 20 weeks, with the first session lasting 1.5 hours and the remaining sessions one hour. Sessions consist of checking in with the patient, discussion of the week's implementation of refeeding, and helping parents separate the illness from their child. In session 2, a family meal provides the therapist with an opportunity for direct observation of the familial interaction patterns around eating. The therapist makes careful and persistent requests for united parental action toward re-feeding and/or regulating eating habits, the primary concern at this point of the treatment, and the therapist tries to create and reinforce a strong parental alliance around efforts at feeding the child.
Primary Outcome Measure Information:
Title
Change in Expected Body Weight Percentage
Description
Expected body weight percentage will be calculated at baseline and end of treatment (6-months) to calculate difference.
Time Frame
Baseline and 6-months
Title
Change in Expected Body Weight Percentage
Description
Expected body weight percentage will be calculated at baseline and 1 year after treatment (18-months) to calculate difference.
Time Frame
Baseline and 18-months
Title
Change in Impairment
Description
Impairment is measured using the Clinical Impairment Assessment, which is a 16-item self-report measure of impairment from eating disorders. Responses are scored using 0, 1, 2, or 3 and the score is calculated using the sum of all items. Possible scores range between 0 - 48, with higher scores indicating more impairment and lower scores indicating less impairment. Change in impairment will be calculated using the baseline and end of treatment (6-months) scores from CIA.
Time Frame
Baseline and 6-months
Title
Change in Impairment
Description
Impairment is measured using the Clinical Impairment Assessment, which is a 16-item self-report measure of impairment from eating disorders. Responses are scored using 0, 1, 2, or 3 and the score is calculated using the sum of all items. Possible scores range between 0 - 48, with higher scores indicating more impairment and lower scores indicating less impairment. Change in impairment will be calculated using the baseline and 1 year after treatment (18-months) scores from CIA.
Time Frame
Baseline and 18-months
Secondary Outcome Measure Information:
Title
Change in Autonomous Eating
Description
Autonomous eating will be measured in total calories consumed during a single-item meal. Change in total calories consumed will be calculated between baseline and end of treatment (6-months).
Time Frame
Baseline and 6-months
Title
Change in Autonomous Eating
Description
Autonomous eating will be measured in total calories consumed during a single-item meal. Change in total calories consumed will be calculated between baseline and 1 year after treatment (18-months).
Time Frame
Baseline and 18-months
Title
Change in Food Cue Learning
Description
Food cue learning is a task completed on a computer that tests associations between food and level of disgust. Pictures of food are shown including fresh and rotten versions of each and participants then rate on a scale from yucky to yummy for each. These ratings produce an extinction rate. There is no set range for scoring, however lower rates indicate more impairment and higher rates indicate less impairment. Extinction rate will be calculated between baseline and end of treatment (6-months).
Time Frame
Baseline and 6-months
Title
Change in Food Cue Learning
Description
Food cue learning is a task completed on a computer that tests associations between food and level of disgust. Pictures of food are shown including fresh and rotten versions of each and participants then rate on a scale from yucky to yummy for each. These ratings produce an extinction rate. There is no set range for scoring, however lower rates indicate more impairment and higher rates indicate less impairment. Extinction rate will be calculated between baseline and 1 year after treatment (18-months).
Time Frame
Baseline and 18-months
Title
Change in Eating Disorder Symptoms
Description
Youth Eating Disorder Questionnaire (Y-EDE-Q) is a self-report measure assessing psychopathology of eating disorders in youth using 39 items. Global scores range from 0 to 6 with higher scores indicating symptoms of higher severity. Scores will be calculated between baseline and end of treatment (6-months).
Time Frame
Baseline and 6-months
Title
Change in Eating Disorder Symptoms
Description
Youth Eating Disorder Questionnaire (Y-EDE-Q) is a self-report measure assessing psychopathology of eating disorders in youth using 39 items. Global scores range from 0 to 6 with higher scores indicating symptoms of higher severity. Scores will be calculated between baseline and end of treatment (6-months).
Time Frame
Baseline and 18-months
Title
Change in Nonjudgmental Body Awareness
Description
Body awareness Questionnaire (BAQ) is a self-report measure assessing awareness of body sensitivity and changes using 18 items on a score range of 18-126. Higher scores indicate more awareness of body regulation. Scores will be calculated between baseline and end of treatment (6-months).
Time Frame
Baseline and 6-months
Title
Change in Nonjudgmental Body Awareness
Description
Body awareness Questionnaire (BAQ) is a self-report measure assessing awareness of body sensitivity and changes using 18 items on a score range of 18-126. Higher scores indicate more awareness of body regulation. Scores will be calculated between baseline and end of treatment (18-months).
Time Frame
Baseline and 18-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 12-18 Speak English Permission from pediatrician or equivalent to receive outpatient care Clinically significant restriction of food intake by EDA-5 or evidence of persistent food avoidance from patient or guardians Evidence of the inability to maintain greater than minimally low body weight based on BMI for age percentiles and growth trajectories Exclusion Criteria: Comorbid psychotic or bipolar disorder Active suicidal ideation Current substance dependence Psychiatric medication initiated or dosage changes <2 weeks from baseline Major medical illness (e.g., diabetes mellitus, Crohn's disease, etc.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Hildebrandt, PsyD
Phone
212-659-8673
Email
tom.hildebrandt@mssm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Bibeau, MA
Phone
212-659-8673
Email
jessica.bibeau@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Hildebrandt, PsyD
Organizational Affiliation
tom.hildebrandt@mssm.edu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Eating and Weight Disorders Program
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Bibeau, MA
Phone
212-659-8673
Email
jessica.bibeau@mssm.edu
First Name & Middle Initial & Last Name & Degree
Tom Hildebrandt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
Specify Other Time FrameTwice yearly and for each publication
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Any purpose. Specify Other Mechanism Data will be made available through the National Institute of Mental Health Data Archive (NDA)

Learn more about this trial

Interoceptive Exposure for Adolescents With Low Weight Eating Disorders

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