Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Psychological Foundation | OTHER |
| The Hilda & Preston Davis Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary aim of this study is to pilot cognitive behavioral therapy (CBT-AR)for avoidant/restrictive food intake disorder (ARFID) in one study for children and adolescents (ages 10-17 years) and one study for adults (ages 18-65 years).
This study is designed to pilot the CBT-AR treatment in youth with ARFID to determine treatment acceptability and efficacy.This includes evaluating the efficacy and acceptability of CBT-AR in reducing primary ARFID symptoms from pre- to post-treatment, and to assess whether improvement in individual symptoms is related to the timing of relevant interventions. The investigators hypothesize that from pre-treatment to post-treatment, subjects with ARFID will decrease severity of self-reported ARFID symptoms, decrease self-reported anxiety and depression, and improve psychosocial functioning. The investigators further hypothesize that overall, subjects with ARFID will have reduced phobic avoidance, sensory sensitivity, and/or low appetite in comparison to their pre-treatment symptoms.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-AR | Experimental | There is only one arm in this study - all participants will be in the same arm, as all participants will receive CBT-AR. There is no control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-AR | Behavioral | 20-30 sessions of cognitive behavioral therapy for avoidant/restrictive food intake disorder (CBT-AR), held once per week in an outpatient setting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pica, ARFID, Rumination Disorder Interview (PARDI) severity score | A semi-structured interview to assess pica, ARFID, and/or rumination disorder diagnosis, severity, and symptoms | Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2]) |
| Measure | Description | Time Frame |
|---|---|---|
| BMI (kg/m^2) | If the patient is underweight, BMI will be used as an outcome measure | Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2]) |
| Food Neophobia Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jennifer J Thomas, Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Kamryn T. Eddy, Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eating Disorders Clinical and Research Program (Massachusetts General Hospital) | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41803077 | Derived | Becker KR, Graver H, Van De Water AL, Dalton AG, Karlson R, Palmer LP, Stern C, Breithaupt L, Burton-Murray H, Kuhnle M, Kristine Hauser NP, Misra M, Lawson EA, Eddy KT, Holsen L, Thomas JJ. An Exploratory Study of Neural Response to Food Cues Following Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder. Int J Eat Disord. 2026 Jul;59(7):1506-1516. doi: 10.1002/eat.70062. Epub 2026 Mar 9. | |
| 34423319 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000080146 | Avoidant Restrictive Food Intake Disorder |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patient will complete the FNS prior to treatment and again after 20 (or 40 week) to assess change in reluctance to new foods
| Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2]) |
| Parent PARDI | A semi-structured interview to assess pica, ARFID, and/or rumination disorder diagnosis, severity, and symptoms (based on parent report) | Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2]) |
| Child Depression Inventory 2 (CDI 2) score | Patient will complete the CDI 2 prior to treatment and again after 20 (or 40 weeks) to assess change in severity of depression | Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2]) |
| State-Trait Anxiety Inventory (STAI) score | Patient will complete the STAI prior to treatment and again after 20 (or 40 weeks) to assess change in severity of anxiety | Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2]) |
| Clinical Impairment Assessment (CIA) score | Patient will complete the CIA prior to treatment and again after 20 (or 40 weeks) to assess change in severity of clinical impairment | Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2]) |
| Hormone data | Patient will complete a test meal and we will collect blood at T0, T30, T60, and T120 prior to treatment and again after 20 (or 40) weeks of CBT-AR, in order to assess the change in hormone levels. | Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2]) |
| Functional magnetic resonance imaging (fMRI) | Patient will complete fMRI scan prior to treatment and again after 20 (or 40) weeks of CBT-AR, in order to assess the change in fMRI paradigms. | Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2]) |
| Derived |
| Thomas JJ, Becker KR, Breithaupt L, Murray HB, Jo JH, Kuhnle MC, Dreier MJ, Harshman S, Kahn DL, Hauser K, Slattery M, Misra M, Lawson EA, Eddy KT. Cognitive-behavioral therapy for adults with avoidant/restrictive food intake disorder. J Behav Cogn Ther. 2021 Mar;31(1):47-55. doi: 10.1016/j.jbct.2020.10.004. Epub 2021 Mar 3. |