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

NCT ID: NCT02963220

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2020-10-31

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).

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.

Conditions

Avoidant/Restrictive Food Intake Disorder (ARFID)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT-AR

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.

Group Type: EXPERIMENTAL

CBT-AR

Intervention Type: BEHAVIORAL

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

Interventions

CBT-AR

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Psychological Foundation

OTHER

Sponsor Role: collaborator

The Hilda & Preston Davis Foundation

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Thomas

Co-Director, Eating Disorders Clinical and Research Program; Associate Professor of Psychology (Psychiatry), Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer J Thomas, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Kamryn T. Eddy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Eating Disorders Clinical and Research Program (Massachusetts General Hospital)

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34423319 (View on PubMed)

Other Identifiers

2016P002108

Identifier Type: -

Identifier Source: org_study_id