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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34AT012194-01A1 | U.S. NIH Grant/Contract | View source |
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Lack of agreement for risk mitigation plan
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-based interoceptive exposure (MBIE) | Experimental | Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBIE | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. |
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Inclusion Criteria:
Patient:
Parent:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robyn Sysko, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, Eating and Weight Disorders Program | New York | New York | 10029 | United States |
All of the individual participant data collected during the trial, after deidentification.
Twice yearly
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.
Any purpose. Specify Other Mechanism Data will be made available through the National Institute of Mental Health Data Archive (NDA)
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness-based Interoceptive Exposure (MBIE) | Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach. MBIE: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness-based Interoceptive Exposure (MBIE) | Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach. MBIE: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data not collected because 6 month visit not completed due to early termination of study. | Posted | up to 6 months |
|
20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness-based Interoceptive Exposure (MBIE) | Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach. MBIE: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal intention | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robyn Sysko, PhD | Icahn School of Medicine at Mount Sinai | 212-659-8724 | Robyn.Sysko@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2024 | Mar 12, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 30, 2024 | Mar 12, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000080146 | Avoidant Restrictive Food Intake Disorder |
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| 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. | 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. | 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. | 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. | 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. | 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. | Baseline and session 20 (at week 20) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Calories consumed during single-item meal | Mean | Standard Deviation | kcal |
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| Child and Adolescent Mindfulness Measure (CAMM) | Total score of CAMM scale is 0-40, higher score indicates higher levels of mindfulness. | Mean | Standard Deviation | units on a scale |
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| Body Awareness Questionnaire (BAQ) | BAQ total score on the scale is 18-126, higher score indicates better health outcomes. | Mean | Standard Deviation | units on a scale |
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| Stanford Feeding Questionnaire - avoidant restrictive food intake disorder (ARFID) Scale | Full scores range from 0-6, higher score indicates more eating pathology. | Mean | Standard Deviation | units on a scale |
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| Stanford Feeding Questionnaire - Parental Feeding Problems Scale | Full scores range from 0-6, higher score indicates more parental feeding difficulty. | Mean | Standard Deviation | units on a scale |
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| Parental self-efficacy scale | Parent versus ARFID - Full scores range from 7-35, higher score indicates more parental self-efficacy. | Mean | Standard Deviation | units on a scale |
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Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach.
MBIE: 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.
|
| Secondary | 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%. | Posted | Mean | Standard Deviation | percentage of adherence to items | Session 20, at week 20 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Session 20, at week 20 |
|
|
|
| Secondary | 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. | Number of participants who completed the respective sessions | Posted | Mean | Standard Deviation | score on a scale | baseline and session 5 (at week 5), session 10 (at week 10), session 20 (at week 20) |
|
|
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| Secondary | 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. | Data not collected because 6 month visit not completed due to early termination of study. | Posted | up to 6 months |
|
|
| Secondary | 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. | Data not collected because 6 month visit not completed due to early termination of study. | Posted | up to 6 months |
|
|
| Secondary | 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. | Number of participants who completed Session 10 and Session 20 | Posted | Mean | Standard Deviation | calories consumed | Baseline and approximately 10 weeks and 20 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | percentile | Baseline and session 20 (at week 20) |
|
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| 0 |
| 12 |
| 1 |
| 12 |
| 1 |
| 12 |
| Lack of weight gain | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Session 10 |
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| Session 20 |
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