Avoidant/Restrictive Food Intake Disorder (ARFID)
Conditions
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALCBT-AR
20-30 sessions of cognitive behavioral therapy for avoidant/restrictive food intake disorder (CBT-AR), held once per week in an outpatient setting
Sponsors
American Psychological Foundation
The Hilda & Preston Davis Foundation
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males and females; ages 10-17 years AND 18-65 years with avoidant/restrictive eating disorder or avoidant/restrictive eating patterns, characterized by either (i) Eating Disorder Assessment-5 (EDA-5) (ii) Kiddie Schedule for Affective Disorders and Schizophrenia for School Age Children-Present and Lifetime Version (KSADS-PL)
Exclusion criteria
* Use of systemic hormones, pregnancy or breastfeeding within eight weeks * History of psychosis by KSADS-PL * Substance or Alcohol Use Disorder active within the past month by KSADS-PL * Active suicidal ideation * Gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection) * Any feeding or eating disorder other than ARFID determined by EDA-5 * Any clinically significant disordered eating as evidenced by EDE-Q global \> 4.0 or self-induced vomiting, laxatives, diuretics, purposeful fasting, or compensatory exercise in past 28 days * Medical history of intellectual disability (IQ\< 70) * Has previously received more than 4 hours of CBT for ARFID in the past * Is currently receiving another form of psychosocial treatment for ARFID (e.g., occupational therapy, speech therapy, another form of psychotherapy) and is unable to discontinue that treatment for the duration of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pica, ARFID, Rumination Disorder Interview (PARDI) severity score | 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]) | A semi-structured interview to assess pica, ARFID, and/or rumination disorder diagnosis, severity, and symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI (kg/m^2) | 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]) | If the patient is underweight, BMI will be used as an outcome measure |
| Food Neophobia Scale | 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]) | Patient will complete the FNS prior to treatment and again after 20 (or 40 week) to assess change in reluctance to new foods |
| Child Depression Inventory 2 (CDI 2) score | 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]) | Patient will complete the CDI 2 prior to treatment and again after 20 (or 40 weeks) to assess change in severity of depression |
| Parent PARDI | 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]) | A semi-structured interview to assess pica, ARFID, and/or rumination disorder diagnosis, severity, and symptoms (based on parent report) |
| Clinical Impairment Assessment (CIA) score | 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]) | Patient will complete the CIA prior to treatment and again after 20 (or 40 weeks) to assess change in severity of clinical impairment |
| Hormone data | 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]) | 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. |
| Functional magnetic resonance imaging (fMRI) | 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]) | 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. |
| State-Trait Anxiety Inventory (STAI) score | 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]) | Patient will complete the STAI prior to treatment and again after 20 (or 40 weeks) to assess change in severity of anxiety |
Countries
United States
Outcome results
None listed