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

NCT02963220 | Completed DMC

• 1 other identifier: 2016P002108
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Avoidant/Restrictive Food Intake Disorder (ARFID)

Outcome Measures

Primary Outcomes (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

  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)

  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

  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

  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

  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

  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])

Study Arms (1)

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.

Behavioral: CBT-AR

Interventions

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

CBT-AR

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Psychological Foundation: collaborator
• The Hilda & Preston Davis Foundation: collaborator

Study Sites (1)

Eating Disorders Clinical and Research Program (Massachusetts General Hospital)

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 34423319 DERIVED

MeSH Terms

Conditions

Avoidant Restrictive Food Intake Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Jennifer J Thomas, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Kamryn T. Eddy, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Eating Disorders Clinical and Research Program; Associate Professor of Psychology (Psychiatry), Harvard Medical School

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 15, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)