Treatment Outcome in Eating Disorders

Eating Disorder Clinical Trial

Official title:

Treatment Outcome in Eating Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599921
• Other study ID #: 47919
• Status: Completed
• Start date: May 6, 2015
• Est. completion date: January 1, 2021

Study information

• Verified date: July 2021
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Eating Disorder
• Feeding and Eating Disorders

Intervention

Behavioral:
• Family-based treatment
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
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
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota	University of California, San Francisco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapy effectiveness	1) Evaluate which therapies work effectively for the treatment of eating disorders, and which types of treatments are most effective for specific diagnoses.	Measured at end of treatment (an average of 6-9 months) and at 6 and 12 month follow-up.
Secondary	Treatment moderators	1) Explore predictors and moderators of treatment outcome.	Measured at end of treatment (an average of 6-9 months) and at 6 and 12 month follow-up.