Avoidant Restrictive Food Intake Disorder
Conditions
Keywords
Avoidant Restrictive Food Intake Disorder, Eating Disorder, Eating Disorder Treatment, Family-Based Therapy, Exposure Therapy, Mindfulness
Brief 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). 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.
Interventions
BEHAVIORALMBIE
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.
Sponsors
Icahn School of Medicine at Mount Sinai
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MBIE-adapted Therapy Suitability and Acceptability Scale to Measure Patient MBIE Therapy Tolerability | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Therapist Adherence to MBIE Therapy | Session 20, at week 20 | 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%. |
| Number of Participants Who Withdrew | Session 20, at week 20 | 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. |
| Participant Rating of Acceptability Scale | baseline and session 5 (at week 5), session 10 (at week 10), session 20 (at week 20) | 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. |
| Functional Food Hierarchy to Measure Tolerability | up to 6 months | 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. |
| Number of MBIE Sessions Required to Achieve Tolerability | up to 6 months | 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. |
| Change in Total Calories Consumed | Baseline and approximately 10 weeks and 20 weeks | 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. |
| Change in Body Mass Index (BMI) Percentile | Baseline and session 20 (at week 20) | Change in BMI percentile at baseline and end of treatment (session 20) to evaluate any changes during treatment. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobyn Sysko, PhD
Icahn School of Medicine at Mount Sinai
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 14.9 years STANDARD_DEVIATION 2.7 |
| Body Awareness Questionnaire (BAQ) | 56.1 units on a scale STANDARD_DEVIATION 19.3 |
| Body Mass Index (BMI) | 19.6 kg/m^2 STANDARD_DEVIATION 3.8 |
| Calories consumed during single-item meal | 100 kcal STANDARD_DEVIATION 145.7 |
| Child and Adolescent Mindfulness Measure (CAMM) | 29.2 units on a scale STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Parental self-efficacy scale | 21.8 units on a scale STANDARD_DEVIATION 3.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
| Stanford Feeding Questionnaire - avoidant restrictive food intake disorder (ARFID) Scale | 4.1 units on a scale STANDARD_DEVIATION 0.9 |
| Stanford Feeding Questionnaire - Parental Feeding Problems Scale | 1.7 units on a scale STANDARD_DEVIATION 0.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 1 / 12 |
| serious Total, serious adverse events | 1 / 12 |
Outcome results
None listed