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Completed

NCT Number: NCT02963220

Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake 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).

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Key information

Conditions

Avoidant/Restrictive Food Intake Disorder (ARFID) Avoidant Restrictive Food Intake Disorder Feeding and Eating Disorders Mental Disorders

Age range

10 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eating Disorders Clinical and Research Program (Massachusetts General Hospital)

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CBT-AR

Behavioral

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

Primary outcomes

  1. 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])

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

Secondary outcomes

  1. BMI (kg/m^2)

    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])

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

  2. Food Neophobia Scale

    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])

    Patient will complete the FNS prior to treatment and again after 20 (or 40 week) to assess change in reluctance to new foods

  3. Parent PARDI

    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])

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

  4. Child Depression Inventory 2 (CDI 2) 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])

    Patient will complete the CDI 2 prior to treatment and again after 20 (or 40 weeks) to assess change in severity of depression

  5. State-Trait Anxiety Inventory (STAI) 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])

    Patient will complete the STAI prior to treatment and again after 20 (or 40 weeks) to assess change in severity of anxiety

  6. Clinical Impairment Assessment (CIA) 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])

    Patient will complete the CIA prior to treatment and again after 20 (or 40 weeks) to assess change in severity of clinical impairment

  7. Hormone data

    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])

    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.

  8. Functional magnetic resonance imaging (fMRI)

    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])

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Psychological Foundation
  • The Hilda & Preston Davis Foundation

Registry information

Official study title

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

Acronym: CBT-AR Pilot

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 15, 2016
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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