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OpenTrials
Completed

NCT Number: NCT03599921

Treatment Outcome in Eating Disorders

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?

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Family-based treatment

Behavioral

Family-based treatment, or FBT, is the leading evidenced based therapy for children and adolescents with an eating disorder.

The treatment is a talking type of treatment that involves the whole family and primarily focuses on helping parents play an active and positive role in helping to restore the patient's weight, then hand control of eating back to the patient as is age appropriate. Toward the end of treatment, it is concerned with developmental issues that may have been impacted by the illness.

Enhanced Cognitive behavioral therapy

Behavioral

Enhanced Cognitive behavioral therapy, or CBT-E, is a leading evidence based treatment for adolescents and adults with an eating disorder.

The treatment is a one-to-one talking type of treatment that primarily focuses on what is keeping the eating problem going. It is therefore mainly concerned with the present and the future. It addresses the origins of the problem as needed.

Family-based treatment modified for ARFID

Behavioral

Family-based treatment modified for individuals with an ARFID diagnosis is a proposed therapy for treating ARFID.

The treatment is a talking type of treatment that involves the whole family and primarily focuses on helping parents play an active and positive role in helping to restore patient's weight and variety in eating, as needed.

FBT + UP for ARFID

Behavioral

Family-based treatment combined with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents is a proposed therapy for treating ARFID.

The treatment is a talking type of treatment that involves the whole family and begins with focus on psychoeducation, family engagement, and weight gain as needed. The Unified Protocol is then added to build skills that empower the patient to cope with difficult emotions, address avoidance, and increase tolerance of emotions or disgust responses.

Primary outcomes

  1. Therapy effectiveness

    Time frame: Measured at end of treatment (an average of 6-9 months) and at 6 and 12 month follow-up.

    • Evaluate which therapies work effectively for the treatment of eating disorders, and which types of treatments are most effective for specific diagnoses.

Secondary outcomes

  1. Treatment moderators

    Time frame: Measured at end of treatment (an average of 6-9 months) and at 6 and 12 month follow-up.

    • Explore predictors and moderators of treatment outcome.

Sponsors and collaborators

Lead sponsor

Children's Hospitals and Clinics of Minnesota

Other

Collaborators

  • University of California, San Francisco

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jul 26, 2018
Registry last updated
Jul 28, 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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