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Clinical Trials/NCT03599921
NCT03599921
Completed
N/A

Treatment Outcome in Eating Disorders

Children's Hospitals and Clinics of Minnesota0 sites275 target enrollmentMay 6, 2015
ConditionsEating Disorder

Overview

Phase
N/A
Intervention
Not specified
Conditions
Eating Disorder
Sponsor
Children's Hospitals and Clinics of Minnesota
Enrollment
275
Primary Endpoint
Therapy effectiveness
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 6, 2015
End Date
January 1, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Eckhardt

Principal Investigator

Children's Hospitals and Clinics of Minnesota

Eligibility Criteria

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.

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.

Outcomes

Primary Outcomes

Therapy effectiveness

Time Frame: 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 Outcomes

  • Treatment moderators(Measured at end of treatment (an average of 6-9 months) and at 6 and 12 month follow-up.)

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