Clinical trial NCT03855553: Project CORE: Disseminating Eating Disorders Treatment
Official title: Disseminating Eating Disorders Education and Treatment Across Multiple Levels of Care: Improving Access in the Rhode Island Medicaid Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Anorexia Nervosa/Bulimia
Anorexia Nervosa Restricting Type
Eating Disorders in Adolescence
Keywords: Anorexia Nervosa
Bulimia Nervosa
Eating Disorders
Adolescence
Clinical Training
Community Outreach
Family Based Treatment
Enhanced Cognitive Behavioral Therapy
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion criteria include:

* meets criteria for AN, atypical AN, or BN according to DSM-5 diagnostic criteria
* is currently living at home
* is medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine (e.g., ≥75% of expected body weight, heartrate ≥50 beats per minute)
* if on a psychotropic medication, meets all eligibility criteria while on stable dose of psychotropic medication (8 weeks) for a co-morbid condition
* speaks English
* be available for long-term follow-up.

Exclusion criteria include:

* associated physical illness that necessitates hospitalization
* psychotic illness/other mental illness requiring hospitalization
* current dependence on drugs or alcohol
* physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
* concurrent involvement in other psychological treatment for an eating disorder
* developmental delay that would preclude participation in the intervention.

Primary outcomes:
measure: BMI percentile
timeFrame: post treatment (week 17)
measure: BMI percentile
timeFrame: 1 year follow up
measure: Eating disorder symptomology, as assessed by the EDE-Q.
timeFrame: post treatment (week 17)
measure: Eating disorder symptomology, as assessed by the ED-15.
timeFrame: post treatment (week 17)
measure: Eating disorder symptomology, as assessed by EDE-Q
timeFrame: 1 year follow-up
measure: Eating disorder symptomology, as assessed by ED-15.
timeFrame: 1 year follow-up
measure: Perceived efficacy of treatment, as assessed by the TSPE
timeFrame: post treatment (week 17)
measure: Perceived efficacy of treatment, as assessed by the CSQ
timeFrame: post treatment (week 17)
measure: Perceived efficacy of treatment, as assessed by the CSQ
timeFrame: 1 year follow-up
measure: Perceived efficacy of treatment, as assessed by the TSPE.
timeFrame: 1 year follow-up
measure: Perceived feasibility of treatment, as assessed by the TSPE.
timeFrame: post treatment (week 17)
measure: Perceived feasibility of treatment, as assessed by the CSQ.
timeFrame: post treatment (week 17)
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Weight Control & Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: Weight Control & Diabetes Research Center
name: Andrea B. Goldschmidt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island College
name: Christina Tortolani, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: