Completed

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

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What is being tested

CBT-AR

Behavioral
Who is being recruted

Avoidant Restrictive Food Intake Disorder

+ Feeding and Eating Disorders

+ Mental Disorders

From 10 to 65 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2016
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleCognitive-Behavioral Therapy for Avoidant/Restrictive Eating Disorder: A Treatment Development and Pilot Study
NCT02963220
Principal SponsorMassachusetts General Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

35 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Avoidant Restrictive Food Intake DisorderFeeding and Eating DisordersMental Disorders

Criteria

1 inclusion criteria required to participate
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)
10 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Eating Disorders Clinical and Research Program (Massachusetts General Hospital)

Boston, United StatesOpen Eating Disorders Clinical and Research Program (Massachusetts General Hospital) in Google Maps
CompletedOne Study Center