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.
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
- Conditions the study is for
- Avoidant/Restrictive Food Intake Disorder (ARFID)
- What is being tested?
- CBT-AR
- Type of treatment
- Lifestyle or therapy programme
- 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
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
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 group | Role | What they receive |
|---|---|---|
| CBT-AR | 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. Receives: Behavioral: CBT-AR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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])
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])
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])
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])
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])
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])
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])
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.
- First posted15 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Avoidant/Restrictive Food Intake Disorder (ARFID)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Foundation, The Hilda & Preston Davis Foundation
- Responsible party
- Principal investigator, Jennifer Thomas, Massachusetts General Hospital
- Investigators
- Jennifer J Thomas, Ph.D., Principal investigator, Massachusetts General HospitalKamryn T. Eddy, Ph.D., Principal investigator, Massachusetts General Hospital
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 41803077Thomas 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