Anorexia NervosaNCT05763849
Interoceptive Exposure for Adolescents With Low Weight Eating Disorders
A study testing Interoceptive Exposure Treatment (IE) and Family-Based Treatment (FBT) in people with Anorexia Nervosa, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Interoceptive Exposure Treatment (IE) and Family-Based Treatment (FBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2023to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Department of Psychiatry, Eating and Weight Disorders Program
New York, New York, 10028
Jessica Bibeau, MA, 212-659-8673, jessica.bibeau@mssm.edu
Thomas Hildebrandt, Psy.D
About this study
Official title: A Confirmatory Efficacy Study of Interoceptive Exposure for Adolescents With Low Weight Eating Disorders
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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Interoceptive Exposure Treatment (IE), Family-Based Treatment (FBT)
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interoceptive Exposure Treatment (IE)Behavioural
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.
Family-Based Treatment (FBT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interoceptive Exposure Treatment (IE) | Experimental | Interoceptive Exposure Therapy (IE) targets food avoidance, food exposure, and body image exposure. Receives: Behavioral: Interoceptive Exposure Treatment (IE) |
| Family-Based Treatment (FBT) | Active comparator | Family-Based Therapy (FBT) focuses on parent-enforced contingencies, increasing value of eating, and decreasing the value of food avoidance. Receives: Behavioral: Family-Based Treatment (FBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Expected Body Weight Percentage
Expected body weight percentage will be calculated at baseline and end of treatment (6-months) to calculate difference.
Measured: Baseline and 6-months
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.
Measured: Baseline and 18-months
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.
Measured: Baseline and 6-months
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.
Measured: Baseline and 18-months
Secondary outcomes (8)
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).
Measured: Baseline and 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).
Measured: Baseline and 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).
Measured: Baseline and 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).
Measured: Baseline and 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).
Measured: Baseline and 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).
Measured: Baseline and 18-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).
Measured: Baseline and 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).
Measured: Baseline and 18-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start14 Mar 2023
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Tom Hildebrandt, Icahn School of Medicine at Mount Sinai
- Investigators
- Thomas Hildebrandt, Psy.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763849
- Sponsor's protocol ID
- STUDY-22-01323
- Other IDs
- 1R01MH131655
- Status last verified
- Jun 2026
- First submitted
- 28 Feb 2023
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Confirmatory Efficacy Study of Interoceptive Exposure for Adolescents With Low Weight Eating Disorders
- ClinicalTrials.gov ID
- NCT05763849
- Acronym / sponsor ID
- STUDY-22-01323
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interoceptive Exposure Treatment (IE) | Experimental | Behavioral: Interoceptive Exposure Treatment (IE)Interoceptive Exposure Therapy (IE) targets food avoidance, food exposure, and body image exposure. |
| Family-Based Treatment (FBT) | Active comparator | Behavioral: Family-Based Treatment (FBT)Family-Based Therapy (FBT) focuses on parent-enforced contingencies, increasing value of eating, and decreasing the value of food avoidance. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interoceptive Exposure Treatment (IE)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. | Behavioural | Interoceptive Exposure Treatment (IE) |
| Family-Based Treatment (FBT)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. | Behavioural | Family-Based Treatment (FBT) |
Primary outcome
Change in Expected Body Weight Percentage
Time frame: Baseline and 6-months
Expected body weight percentage will be calculated at baseline and end of treatment (6-months) to calculate difference.
Change in Expected Body Weight Percentage
Time frame: Baseline and 18-months
Expected body weight percentage will be calculated at baseline and 1 year after treatment (18-months) to calculate difference.
Change in Impairment
Time frame: Baseline and 6-months
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
Time frame: Baseline and 18-months
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.
8 secondary outcomes
Change in Autonomous Eating
Time frame: Baseline and 6-months
Change in Autonomous Eating
Time frame: Baseline and 18-months
Change in Food Cue Learning
Time frame: Baseline and 6-months
Change in Food Cue Learning
Time frame: Baseline and 18-months
Change in Eating Disorder Symptoms
Time frame: Baseline and 6-months
Change in Eating Disorder Symptoms
Time frame: Baseline and 18-months
Change in Nonjudgmental Body Awareness
Time frame: Baseline and 6-months
Change in Nonjudgmental Body Awareness
Time frame: Baseline and 18-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Hildebrandt, Psy.D. principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interoceptive Exposure Treatment (IE) and Family-Based Treatment (FBT) in people with Anorexia Nervosa, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Hildebrandt, Psy.D. ((212) 659-8673, tom.hildebrandt@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Expected Body Weight Percentage (time frame: Baseline and 6-months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.