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

Primary Purpose

Avoidant/Restrictive Food Intake Disorder (ARFID)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT-AR
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Avoidant/Restrictive Food Intake Disorder (ARFID)

Eligibility Criteria

10 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eating Disorders Clinical and Research Program (Massachusetts General Hospital)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBT-AR

Arm Description

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.

Outcomes

Primary Outcome Measures

Pica, ARFID, Rumination Disorder Interview (PARDI) severity score
A semi-structured interview to assess pica, ARFID, and/or rumination disorder diagnosis, severity, and symptoms

Secondary Outcome Measures

BMI (kg/m^2)
If the patient is underweight, BMI will be used as an outcome measure
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
Parent PARDI
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
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
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
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
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)
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.

Full Information

First Posted
October 31, 2016
Last Updated
February 22, 2021
Sponsor
Massachusetts General Hospital
Collaborators
American Psychological Foundation, The Hilda & Preston Davis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02963220
Brief Title
Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder: A Treatment Development and Pilot Study
Acronym
CBT-AR Pilot
Official Title
Cognitive-Behavioral Therapy for Avoidant/Restrictive Eating Disorder: A Treatment Development and Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
October 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
American Psychological Foundation, The Hilda & Preston Davis Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avoidant/Restrictive Food Intake Disorder (ARFID)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-AR
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT-AR
Intervention Description
20-30 sessions of cognitive behavioral therapy for avoidant/restrictive food intake disorder (CBT-AR), held once per week in an outpatient setting
Primary Outcome Measure Information:
Title
Pica, ARFID, Rumination Disorder Interview (PARDI) severity score
Description
A semi-structured interview to assess pica, ARFID, and/or rumination disorder diagnosis, severity, and symptoms
Time Frame
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 Measure Information:
Title
BMI (kg/m^2)
Description
If the patient is underweight, BMI will be used as an outcome measure
Time Frame
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])
Title
Food Neophobia Scale
Description
Patient will complete the FNS prior to treatment and again after 20 (or 40 week) to assess change in reluctance to new foods
Time Frame
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])
Title
Parent PARDI
Description
A semi-structured interview to assess pica, ARFID, and/or rumination disorder diagnosis, severity, and symptoms (based on parent report)
Time Frame
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])
Title
Child Depression Inventory 2 (CDI 2) score
Description
Patient will complete the CDI 2 prior to treatment and again after 20 (or 40 weeks) to assess change in severity of depression
Time Frame
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])
Title
State-Trait Anxiety Inventory (STAI) score
Description
Patient will complete the STAI prior to treatment and again after 20 (or 40 weeks) to assess change in severity of anxiety
Time Frame
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])
Title
Clinical Impairment Assessment (CIA) score
Description
Patient will complete the CIA prior to treatment and again after 20 (or 40 weeks) to assess change in severity of clinical impairment
Time Frame
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])
Title
Hormone data
Description
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.
Time Frame
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])
Title
Functional magnetic resonance imaging (fMRI)
Description
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.
Time Frame
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])

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer J Thomas, Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kamryn T. Eddy, Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eating Disorders Clinical and Research Program (Massachusetts General Hospital)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34423319
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.
Results Reference
derived

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

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