Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder: A Treatment Development and Pilot Study (CBT-AR Pilot)

Cognitive-Behavioral Therapy for Avoidant/Restrictive Eating Disorder: A Treatment Development and Pilot Study

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).

Study Overview

• Status: Completed
• Conditions: Avoidant/Restrictive Food Intake Disorder (ARFID)
• Intervention / Treatment: Behavioral: CBT-AR

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Eating Disorders Clinical and Research Program (Massachusetts General Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: CBT-AR; 20-30 sessions of cognitive behavioral therapy for avoidant/restrictive food intake disorder (CBT-AR), held once per week in an outpatient setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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])

Secondary Outcome Measures

Outcome Measure	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	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])

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: American Psychological Foundation; The Hilda & Preston Davis Foundation
• Investigators: Principal Investigator: Jennifer J Thomas, Ph.D., Massachusetts General Hospital; Principal Investigator: Kamryn T. Eddy, Ph.D., Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: November 9, 2016
• First Posted (Estimate): November 15, 2016

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Avoidant Restrictive Food Intake Disorder
• Other Study ID Numbers: 2016P002108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No