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Avoidant/Restrictive Food Intake Disorder (ARFID)CBT-AR PilotNCT02963220

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

A study testing CBT-AR in people with Avoidant/Restrictive Food Intake Disorder (ARFID), run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 10 to 65 years
What is being tested?
CBT-AR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Oct 2016to Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
CBT-AR
Medical subject headings
Avoidant Restrictive Food Intake Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBT-ARBehavioural

    20-30 sessions of cognitive behavioral therapy for avoidant/restrictive food intake disorder (CBT-AR), held once per week in an outpatient setting

Study groups in NCT02963220
Study groupRoleWhat they receive
CBT-ARExperimentalThere 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.
Receives: Behavioral: CBT-AR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pica, ARFID, Rumination Disorder Interview (PARDI) severity score

    A semi-structured interview to assess pica, ARFID, and/or rumination disorder diagnosis, severity, and symptoms

    Measured: 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 (8)

  1. BMI (kg/m^2)

    If the patient is underweight, BMI will be used as an outcome measure

    Measured: 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])

  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

    Measured: 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])

  3. Parent PARDI

    A semi-structured interview to assess pica, ARFID, and/or rumination disorder diagnosis, severity, and symptoms (based on parent report)

    Measured: 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])

  4. 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

    Measured: 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])

  5. 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

    Measured: 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])

  6. 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

    Measured: 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])

  7. 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.

    Measured: 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])

  8. 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.

    Measured: 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])

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionOct 2020
  4. Study completionOct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02963220
Sponsor's protocol ID
2016P002108
Acronym
CBT-AR Pilot
Status last verified
Feb 2021
First submitted
31 Oct 2016
Last updated
24 Feb 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Becker KR, Graver H, Van De Water AL, Dalton AG, Karlson R, Palmer LP, Stern C, Breithaupt L, Burton-Murray H, Kuhnle M, Kristine Hauser NP, Misra M, Lawson EA, Eddy KT, Holsen L, Thomas JJ. An Exploratory Study of Neural Response to Food Cues Following Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder. Int J Eat Disord. 2026 Jul;59(7):1506-1516. doi: 10.1002/eat.70062. Epub 2026 Mar 9.

    PubMed 41803077

  • 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.

    PubMed 34423319

Questions about this trial

What is this clinical trial studying?

A study testing CBT-AR in people with Avoidant/Restrictive Food Intake Disorder (ARFID), run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pica, ARFID, Rumination Disorder Interview (PARDI) severity score (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])). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02963220, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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