Avoidant Restrictive Food Intake DisorderNCT06110806
Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder
A study testing MBIE in people with Avoidant Restrictive Food Intake Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This project aims to establish the feasibility and acceptability of a comprehensive mind and body intervention; specifically a mindfulness-based interoceptive exposure (MBIE) for families of youth diagnosed with avoidant/restrictive food intake disorder (ARFID). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Avoidant Restrictive Food Intake Disorder
- What is being tested?
- MBIE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2023to 8 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient:
- Aged 12-18
- Speaks English
- Permission from pediatrician or equivalent to receive outpatient care, including that the patient does not meet criteria for hospitalization based on the American Psychiatric Association guidelines
- Diagnosis of Avoidant Restrictive Food Intake Disorder, as assessed by the EDA-5
- Parent:
- Has a child aged 12-18 with a diagnosis of ARFID
- Speaks English
Who cannot join
- Comorbid psychotic or bipolar disorder
- Psychiatric medication initiated or with a dosage change in the two weeks prior to baseline testing
- Active suicidal ideation
- Major medical condition (e.g., diabetes mellitus, pregnancy)
- Current substance dependence, as evidenced by tolerance and withdrawal
- Evidence of anatomical findings by imaging (e.g., swallow study) that would prevent safe consumption of the shake or those with a percutaneous endoscopic gastrostomy or other similar feeding tube insertion
- Children with visual or physical limitations that would preclude watching a screen and using a finger to respond with mouse clicks (e.g., blindness, epilepsy if exposure to flashing lights at certain intensities or to certain visual patterns can trigger seizures).
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychiatry, Eating and Weight Disorders Program
New York, New York, 10029
About this study
This project aims to establish the feasibility and acceptability of a comprehensive mind and body intervention; specifically a mindfulness-based interoceptive exposure (MBIE) for families of youth diagnosed with avoidant/restrictive food intake disorder (ARFID). This project will: (1) explore the feasibility of recruitment, retention, and data collection procedures with youth with ARFID at end of treatment, (2) establish the acceptability and adherence of the MBIE intervention, and (3) evaluate the number of MBIE sessions required to observe changes in the number of foods avoided and mindfulness skills.
Read the detailed description
A total of 57 individuals with ARFID ages 12-18 will be enrolled to outpatient mindfulness-based interoceptive exposure (MBIE). MBIE targets increasing psychological flexibility and acceptance by decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning. MBIE will be administered in 20 sessions. Interview, self-report, anthropometrics, laboratory feeding, and behavioral task data will be used to characterize the sample to their response to treatment over time. Follow-up assessments will be completed at session 5, 10, 15, and 20. The final assessment will take place 3 months after treatment ends. Total participation will last 9 months.
- Being tested
- MBIE
- Keywords
- Avoidant Restrictive Food Intake Disorder, Eating Disorder, Eating Disorder Treatment, Family-Based Therapy, Exposure Therapy, Mindfulness
- Medical subject headings
- Avoidant Restrictive Food Intake Disorder, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBIEBehavioural
MBIE administered over 20 sessions, targets increasing psychological flexibility and acceptance by decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based interoceptive exposure (MBIE) | Experimental | Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach. Receives: Behavioral: MBIE |
What is being measured
The primary outcome is the main question the study is designed to answer.
MBIE-adapted Therapy Suitability and Acceptability Scale to Measure Patient MBIE Therapy Tolerability
An MBIE-adapted Therapy Suitability and Acceptability Scale will average specific items from patient's view on match of therapy to the problem, responsiveness of intervention to different treatment challenges, degree of unexpected discomfort related to treatment, interest in using therapy experiences beyond the therapy session. This scale includes 10-20 items, depending on the session content, and is measured using a Likert scale from 1-7. Scores are calculated using a sum of all items, with a possible range of scores of 10 to 140. Higher scores indicate greater suitability of the treatment for the child and expectancy of success with the intervention.
Measured: up to 6 months
Secondary outcomes (7)
Therapist Adherence to MBIE Therapy
Adherence of the MBIE intervention will be measured with ratings of therapy tapes of 20 sessions. Adherence will be calculated using a dichotomous scale (yes/no) of items rating the extent of use of treatment elements and the quality of delivery of the intervention. As the number of treatment elements vary, and some items are reverse coded, the minimum, maximum, and scaling are not utilized. Per item adherence can range from 0 to 100%.
Measured: Session 20, at week 20
Number of Participants Who Withdrew
Retention will be measured using rates of dropout between baseline and session 20 (end of treatment, at approximately 6 months). Number of participants who withdrew prior to termination of study.
Measured: Session 20, at week 20
Participant Rating of Acceptability Scale
Acceptability of data collection and assessment procedures will be measured using participant ratings of acceptability for total time and frequency on an investigator-derived scale. This measurement includes items assessing the (1) tolerability and (2) ease of completing laboratory, behavior, and self-report tasks using a 15 mm visual analog scale. Questions are scored from 0-15 and then all scores are summed for an acceptability score. Ranges include 0-120 at baseline, 0 to 30 at Session 5, 0-120 at Session 10, and 0-120 at Session 20. Higher scores indicate greater acceptability of study assessments.
Measured: baseline and session 5 (at week 5), session 10 (at week 10), session 20 (at week 20)
Functional Food Hierarchy to Measure Tolerability
The number of MBIE sessions required to achieve a clinically meaningful outcome and acceptable tolerability using a Functional Food Hierarchy. This measurement rates a minimum of 11 food items on a scale of 0-10 at 10 levels of the hierarchy (subjective units of distress). Scores range from 0-100 with higher scores indicating lower avoidance/increased consumption.
Measured: up to 6 months
Number of MBIE Sessions Required to Achieve Tolerability
The number of MBIE sessions required to achieve a clinically meaningful outcome (consuming food rated as70 or higher on the Food Avoidance Scale). The Food Avoidance Scale is investigator-derived and includes 1 item rated on a scale of 0-100 with higher scores indicating consumption of more challenging/avoided foods.
Measured: up to 6 months
Change in Total Calories Consumed
Autonomous eating will be measured in total calories consumed during a single-item meal. Total calories consumed will be calculated between baseline and session 10 of treatment, and between baseline and session 20 of treatment.
Measured: Baseline and approximately 10 weeks and 20 weeks
Change in Body Mass Index (BMI) Percentile
Change in BMI percentile at baseline and end of treatment (session 20) to evaluate any changes during treatment.
Measured: Baseline and session 20 (at week 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start17 Oct 2023
- Primary completion8 Jul 2024
- Study completion8 Jul 2024
Why it stopped: Lack of agreement for risk mitigation plan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Avoidant Restrictive Food Intake DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This single-site clinical trial includes non-randomizing, dose-optimizing (20 sessions) clinical trial design to examine feasibility and appropriate duration of treatment. A final assessment will take place 3-months post intervention.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Robyn Sysko, Icahn School of Medicine at Mount Sinai
- Investigators
- Robyn Sysko, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110806
- Sponsor's protocol ID
- STUDY-23-00440
- Other IDs
- 1R34AT012194-01A1
- Status last verified
- May 2026
- First submitted
- 26 Oct 2023
- Last updated
- 10 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder
- ClinicalTrials.gov ID
- NCT06110806
- Acronym / sponsor ID
- STUDY-23-00440
- Keywords
- Avoidant Restrictive Food Intake Disorder, Eating Disorder, Eating Disorder Treatment, Family-Based Therapy, Exposure Therapy, Mindfulness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of agreement for risk mitigation plan
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Posted 10 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to establish the feasibility and acceptability of a comprehensive mind and body intervention; specifically a mindfulness-based interoceptive exposure (MBIE) for families of youth diagnosed with avoidant/restrictive food intake disorder (ARFID). This project will: (1) explore the feasibility of recruitment, retention, and data collection procedures with youth with ARFID at end of treatment, (2) establish the acceptability and adherence of the MBIE intervention, and (3) evaluate the number of MBIE sessions required to observe changes in the number of foods avoided and mindfulness skills.
Detailed description
A total of 57 individuals with ARFID ages 12-18 will be enrolled to outpatient mindfulness-based interoceptive exposure (MBIE). MBIE targets increasing psychological flexibility and acceptance by decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning. MBIE will be administered in 20 sessions. Interview, self-report, anthropometrics, laboratory feeding, and behavioral task data will be used to characterize the sample to their response to treatment over time. Follow-up assessments will be completed at session 5, 10, 15, and 20. The final assessment will take place 3 months after treatment ends. Total participation will last 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single-site clinical trial includes non-randomizing, dose-optimizing (20 sessions) clinical trial design to examine feasibility and appropriate duration of treatment. A final assessment will take place 3-months post intervention.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based interoceptive exposure (MBIE) | Experimental | Behavioral: MBIEOutpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Aged 12-18
- Speaks English
- Permission from pediatrician or equivalent to receive outpatient care, including that the patient does not meet criteria for hospitalization based on the American Psychiatric Association guidelines
- Diagnosis of Avoidant Restrictive Food Intake Disorder, as assessed by the EDA-5
- Has a child aged 12-18 with a diagnosis of ARFID
Key exclusion criteria (7 listed)
- Comorbid psychotic or bipolar disorder
- Psychiatric medication initiated or with a dosage change in the two weeks prior to baseline testing
- Active suicidal ideation
- Major medical condition (e.g., diabetes mellitus, pregnancy)
- Current substance dependence, as evidenced by tolerance and withdrawal
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 |
|---|---|---|
| MBIEMBIE administered over 20 sessions, targets increasing psychological flexibility and acceptance by decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning. | Behavioural | Mindfulness-based interoceptive exposure (MBIE) |
Primary outcome
MBIE-adapted Therapy Suitability and Acceptability Scale to Measure Patient MBIE Therapy Tolerability
Time frame: up to 6 months
An MBIE-adapted Therapy Suitability and Acceptability Scale will average specific items from patient's view on match of therapy to the problem, responsiveness of intervention to different treatment challenges, degree of unexpected discomfort related to treatment, interest in using therapy experiences beyond the therapy session. This scale includes 10-20 items, depending on the session content, and is measured using a Likert scale from 1-7. Scores are calculated using a sum of all items, with a possible range of scores of 10 to 140. Higher scores indicate greater suitability of the treatment for the child and expectancy of success with the intervention.
7 secondary outcomes
Therapist Adherence to MBIE Therapy
Time frame: Session 20, at week 20
Number of Participants Who Withdrew
Time frame: Session 20, at week 20
Participant Rating of Acceptability Scale
Time frame: baseline and session 5 (at week 5), session 10 (at week 10), session 20 (at week 20)
Functional Food Hierarchy to Measure Tolerability
Time frame: up to 6 months
Number of MBIE Sessions Required to Achieve Tolerability
Time frame: up to 6 months
Change in Total Calories Consumed
Time frame: Baseline and approximately 10 weeks and 20 weeks
Change in Body Mass Index (BMI) Percentile
Time frame: Baseline and session 20 (at week 20)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Related trials for Avoidant Restrictive Food Intake Disorder
Not yet recruiting
Parent-Based Intervention for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)
Anxiety Disorder of Adolescence, Avoidant / Restrictive Food Intake Disorder
Recruiting
Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder Part II
Avoidant/Restrictive Food Intake Disorder (ARFID)
Not yet recruiting
Sensory Feeding and Parent Coaching for Children With ARFID
ARFID
Recruiting
Non-invasive Cranial Electrical Stimulation for Mealtime Anxiety in Adults With Eating Disorders
Eating Disorders, Anxiety
Recruiting
Clinical Trial of "Exploradores de Sabores" to Improve Food Selectivity in ASD Kids
Autism Spectrum Disorder, Food Selectivity
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. This study is not recruiting at the moment.
Robyn Sysko, PhD 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 MBIE in people with Avoidant Restrictive Food Intake Disorder, 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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 10 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?
Yes. Results are posted in the registry (first posted 10 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MBIE-adapted Therapy Suitability and Acceptability Scale to Measure Patient MBIE Therapy Tolerability (time frame: up to 6 months). 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 10 Jun 2026.