Clinical trial NCT03599921: Treatment Outcome in Eating Disorders
Official title: Treatment Outcome in Eating Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eating Disorder
Keywords: 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
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2018-07-26
Enrollment: 275
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Therapy effectiveness
timeFrame: Measured at end of treatment (an average of 6-9 months) and at 6 and 12 month follow-up.
Secondary outcomes:
measure: Treatment moderators
timeFrame: Measured at end of treatment (an average of 6-9 months) and at 6 and 12 month follow-up.
Other outcomes:
Locations:
Study officials:
References:
citation: Le Grange D, Eckhardt S, Dalle Grave R, Crosby RD, Peterson CB, Keery H, Lesser J, Martell C. Enhanced cognitive-behavior therapy and family-based treatment for adolescents with an eating disorder: a non-randomized effectiveness trial. Psychol Med. 2020 Dec 3;52(13):1-11. doi: 10.1017/S0033291720004407. Online ahead of print.