Clinical trial NCT02963220: Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder: A Treatment Development and Pilot Study
Official title: Cognitive-Behavioral Therapy for Avoidant/Restrictive Eating Disorder: A Treatment Development and Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Avoidant/Restrictive Food Intake Disorder (ARFID)
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Psychological Foundation
name: The Hilda & Preston Davis Foundation
First posted: 2016-11-15
Enrollment: 35
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pica, ARFID, Rumination Disorder Interview (PARDI) severity score
timeFrame: 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])
Secondary outcomes:
measure: BMI (kg/m^2)
timeFrame: 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: Food Neophobia Scale
timeFrame: 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: Parent PARDI
timeFrame: 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: Child Depression Inventory 2 (CDI 2) score
timeFrame: 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: State-Trait Anxiety Inventory (STAI) score
timeFrame: 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: Clinical Impairment Assessment (CIA) score
timeFrame: 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: Hormone data
timeFrame: 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: Functional magnetic resonance imaging (fMRI)
timeFrame: 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])
Other outcomes:
Locations:
city: Boston
country: United States
facility: Eating Disorders Clinical and Research Program (Massachusetts General Hospital)
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jennifer J Thomas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Kamryn T. Eddy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.