Treatment Outcome in Eating Disorders

Completed

• Conditions: Eating Disorder
• Interventions: Behavioral: Family-based treatment; Behavioral: Enhanced Cognitive behavioral therapy; Behavioral: Family-based treatment modified for ARFID; Behavioral: FBT + UP for ARFID

• Registration Number: NCT03599921
• Lead Sponsor: Children's Hospitals and Clinics of Minnesota

Brief Summary

Do the current eating disorder treatments, i.e., Family-based Treatment (FBT) and Enhanced Cognitive behavioral therapy (CBT-E), offered at the Center for the Treatment of Eating Disorders (CTED) demonstrate effectiveness? Specifically, which type of treatment is most effective for which diagnoses? Participants with Anorexia Nervosa (AN), Bulimia Nervosa (BN), Other Specified Feeding or Eating Disorder (OSFED), or Unspecified Feeding or Eating Disorder (UFED) in this study will self select one of the two treatment groups, FBT or CBT-E.

Additionally, does Family-based Treatment (FBT) modified for Avoidant/Restrictive Food Intake Disorder (ARFID) and Family-based Treatment (FBT) combined with the Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders (FBT+UP for ARFID) demonstrate effectiveness for patients with an Avoidant/Restrictive Food Intake Disorder (ARFID) diagnosis?

Detailed Description

Given a significant number of patients who presented for treatment at the Center for the Treatment of Eating Disorders (CTED) and were enrolled in this effectiveness study met criteria for a diagnosis of Avoidant/Restrictive Food Intake Disorder (ARFID), and because there are currently no randomized control trials systematically evaluating children/adolescents with ARFID, a secondary aim was added to this study.

The secondary aim will evaluate the preliminary effectiveness of two treatment groups including: Family-based Treatment (FBT) modified for ARFID and Family-based Treatment (FBT) combined with the Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders (FBT+UP for ARFID) for ARFID patients.

Study Timeline

• Study Start: 2015-05-06
• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-07-26
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

• Patients must be at least 6 years of age, attending the CTED clinic for outpatient treatment of a Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosed eating disorder in order to be included in this study.

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Exclusion Criteria

• Participants who are receiving inpatient services only and will not return to CTED for outpatient treatment.
• Participants with a co-morbid medical disorder known to influence eating or weight.
• Participants presenting with a significant psychotic disorder.
• Participants who are acutely suicidal.
• Participants who demonstrate significant substance abuse and/or substance dependence.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Family-based Treatment	Family-based treatment	Participants will receive family-based treatment.
Enhanced Cognitive behavioral therapy	Enhanced Cognitive behavioral therapy	Participants will receive enhance cognitive behavioral therapy.
Family-based Treatment for ARFID	Family-based treatment modified for ARFID	Participants will receive family-based treatment modified for Avoidant/Restrictive Food Intake Disorder (ARFID).
FBT + UP for ARFID	FBT + UP for ARFID	Participants will receive family-based treatment with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents, named FBT + UP for ARFID.

Primary Outcome Measures

Name	Time	Method
Therapy effectiveness	Measured at end of treatment (an average of 6-9 months) and at 6 and 12 month follow-up.	1) Evaluate which therapies work effectively for the treatment of eating disorders, and which types of treatments are most effective for specific diagnoses.

Secondary Outcome Measures

Name	Time	Method
Treatment moderators	Measured at end of treatment (an average of 6-9 months) and at 6 and 12 month follow-up.	1) Explore predictors and moderators of treatment outcome.