Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment Outcome in Eating Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03599921
Recruitment Status : Active, not recruiting
First Posted : July 26, 2018
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Sarah Eckhardt, 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?


Condition or disease Intervention/treatment
Eating Disorder 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 190 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Outcome in Eating Disorders
Actual Study Start Date : May 6, 2015
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : December 31, 2024

Group/Cohort 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.





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Treatment moderators [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Labs


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The investigators plan to enroll 1000 patients, both male and female, ages 6 to adult (18 and older) over a 5 year period. Patients who have been given a Diagnostic and Statistical Manual, 5th Edition (DSM-5) eating disorder diagnosis, and who are seeking outpatient treatment will all be approached for consent to participate in this study.
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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sarah Eckhardt, Principal Investigator, Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT03599921    
Other Study ID Numbers: 47919
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sarah Eckhardt, Children's Hospitals and Clinics of Minnesota:
Family-based Treatment
Enhanced Cognitive Behavioral Therapy
Anorexia Nervosa
Other Specified Feeding or Eating Disorder
Bulimia Nervosa
Unspecified Feeding or Eating Disorder
Avoidant/Restrictive Food Intake Disorder
Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders