Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder: A Treatment Development and Pilot Study
- Conditions
- Avoidant/Restrictive Food Intake Disorder (ARFID)
- Interventions
- Behavioral: CBT-AR
- Registration Number
- NCT02963220
- Lead Sponsor
- Massachusetts General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CBT-AR CBT-AR 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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.
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)
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
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
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.
Trial Locations
- Locations (1)
Eating Disorders Clinical and Research Program (Massachusetts General Hospital)
🇺🇸Boston, Massachusetts, United States