Project CORE: Disseminating Eating Disorders Treatment

Status Recruiting

Clinical Trial Summary

The goals of this project are to 1) develop training opportunities for master's-level and pre-doctoral psychology students in evidence-based assessment and treatment of adolescent EDs; 2) to provide the healthcare workforce, including licensed health professionals such as primary care physicians and behavioral health interventionists, with knowledge and competence to recognize early symptoms of and intervention strategies for EDs; and 3) to test the efficacy of delivering two evidence-based treatments for adolescent eating disorders, Family Based Treatment (FBT) and Enhanced Cognitive Behavioral Therapy (CBT-E), in the home-based setting.

Clinical Trial Description

The complete project will incorporate three phases. Phase I is designed to gather information from existing licensed health professionals in the community who serve Medicaid populations on their knowledge needs and priorities related to screening and intervening with patients with eating disorders. Phase I will comprise eating disorder psycho-education, implementation of workshops, and supervision among primary care professionals and mental health workers. Responses will inform the content of in-services and program development (e.g., monthly consultation services, ongoing multi-family support groups) provided in Phase II. During Phase II, families containing a child with a restrictive-type eating disorder will be recruited to receive treatment from the clinicians assessed and trained during Phase I. Families will be assigned to receive either Family Based Treatment (FBT) or Enhanced Cognitive Behavioral Therapy (CBT-E) to treat their adolescent's eating disorder. Treatment will occur over 10-16 weeks, depending on the family's needs and availability. Families will be assessed at pre-treatment, post-treatment, and 1-year follow-up. Phase III will consist of follow-up with the families and clinicians, and further development of training/education approaches for the Rhode Island healthcare workforce. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03855553
Study type	Interventional
Source	The Miriam Hospital
Contact	Erin R. Stalvey
Phone	(401) 793-8962
Email	estalvey@lifespan.org
Status	Recruiting
Phase	Phase 1
Start date	January 1, 2019
Completion date	January 2022

View Details

See also
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Terminated	`NCT05073679` - Oral Naltrexone In Pediatric Eating Disorders	Phase 2/Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.