Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
275 participants
OBSERVATIONAL
2015-05-06
2021-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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?
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Optimizing Provider Training in Eating Disorders (OPTED)
NCT05389657
Cognitive-behavioral Therapy vs. Nutrition Counseling for Avoidant/Restrictive Food Intake Disorder
NCT05954728
Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
NCT05587127
MICBT for Non-underweight Adults With Eating Disorders
NCT05503745
Study of Treatment for Adolescents With Bulimia Nervosa
NCT00879151
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Family-based Treatment
Participants will receive family-based treatment.
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.
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).
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
6 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, San Francisco
OTHER
Children's Hospitals and Clinics of Minnesota
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sarah Eckhardt
Principal Investigator
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
47919
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.