Treatment Outcome in Eating Disorders

Sponsor
Children's Hospitals and Clinics of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT03599921
Collaborator
University of California, San Francisco (Other)
275
67.9

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Family-based treatment
  • Behavioral: Enhanced Cognitive behavioral therapy
  • Behavioral: Family-based treatment modified for ARFID
  • Behavioral: FBT + UP for ARFID

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 Design

Study Type:
Observational
Actual Enrollment :
275 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Treatment Outcome in Eating Disorders
Actual Study Start Date :
May 6, 2015
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Family-based Treatment

Participants will receive family-based treatment.

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

Participants will receive enhance cognitive behavioral therapy.

Behavioral: 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 for ARFID

Participants will receive family-based treatment modified for Avoidant/Restrictive Food Intake Disorder (ARFID).

Behavioral: 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

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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Children's Hospitals and Clinics of Minnesota
  • University of California, San Francisco

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sarah Eckhardt, Principal Investigator, Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT03599921
Other Study ID Numbers:
  • 47919
First Posted:
Jul 26, 2018
Last Update Posted:
Jul 28, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sarah Eckhardt, Principal Investigator, Children's Hospitals and Clinics of Minnesota
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2021