Treatment Outcome in Eating Disorders
1 other identifier
observational
275
0 countries
N/A
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2015
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 6, 2015
CompletedFirst Submitted
Initial submission to the registry
May 18, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedJuly 28, 2021
July 1, 2021
5.7 years
May 18, 2018
July 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Treatment moderators
Measured at end of treatment (an average of 6-9 months) and at 6 and 12 month follow-up.
Study Arms (4)
Family-based Treatment
Participants will receive family-based treatment.
Enhanced Cognitive behavioral therapy
Participants will receive enhance cognitive behavioral therapy.
Family-based Treatment for ARFID
Participants will receive family-based treatment modified for Avoidant/Restrictive Food Intake Disorder (ARFID).
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.
Interventions
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, 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 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.
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 33267919DERIVED
Biospecimen
Labs
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 18, 2018
First Posted
July 26, 2018
Study Start
May 6, 2015
Primary Completion
January 1, 2021
Study Completion
January 1, 2021
Last Updated
July 28, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share