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Project CORE: Disseminating Eating Disorders Treatment

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Lifespan

Status and phase

Unknown
Phase 1

Conditions

Anorexia Nervosa/Bulimia
Anorexia Nervosa Restricting Type
Eating Disorders in Adolescence

Treatments

Behavioral: Enhanced Cognitive Behavioral Therapy
Behavioral: Family Based Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03855553
1319865

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

FBT
Experimental group
Description:
10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.
Treatment:
Behavioral: Family Based Treatment
CBT-E
Experimental group
Description:
10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.
Treatment:
Behavioral: Enhanced Cognitive Behavioral Therapy

Trial contacts and locations

1

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Central trial contact

Erin R. Stalvey; Eva-Molly Dunbar

Data sourced from clinicaltrials.gov

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