Project CORE: Disseminating Eating Disorders Treatment
Disseminating Eating Disorders Education and Treatment Across Multiple Levels of Care: Improving Access in the Rhode Island Medicaid Population
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2019
Typical duration for phase_1
1 active site
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
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 21, 2019
CompletedFirst Posted
Study publicly available on registry
February 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedFebruary 23, 2021
August 1, 2020
3 years
February 21, 2019
February 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
BMI percentile
post treatment (week 17)
BMI percentile
1 year follow up
Eating disorder symptomology, as assessed by the EDE-Q.
Patient will complete the Eating Disorder Examination Questionnaire (EDE-Q) to assess the frequency and severity of specific eating disorder behaviors and cognitions. Averages of the 28-item measure range from 0 to 6, with higher score indicating higher eating disorder symptomology.
post treatment (week 17)
Eating disorder symptomology, as assessed by the ED-15.
Patient will complete the Eating Disorder 15 (ED-15) to assess the frequency and severity of specific eating disorder behaviors and cognitions. Average scores from the 15-item measure range from 1 - 5, with higher scores indicating higher eating disorder symptomology.
post treatment (week 17)
Eating disorder symptomology, as assessed by EDE-Q
Patient will complete the Eating Disorder Examination Questionnaire (EDE-Q) to assess the frequency and severity of specific eating disorder behaviors and cognitions. Average scores of the 28-item measure range from 0 to 6, with higher score indicating higher eating disorder symptomology.
1 year follow-up
Eating disorder symptomology, as assessed by ED-15.
Patient will complete the Eating Disorder 15 (ED-15) to assess the frequency and severity of specific eating disorder behaviors and cognitions. Average scores from the 15-item measure range from 1 - 5, with higher scores indicating higher eating disorder symptomology.
1 year follow-up
Perceived efficacy of treatment, as assessed by the TSPE
One item from the Treatment Suitability and Patient Expectancy (TSPE) survey will assess how successful the patient perceived treatment to be. This item ranges from 0 - 10, with higher scores indicating higher perceived efficacy.
post treatment (week 17)
Perceived efficacy of treatment, as assessed by the CSQ
The Client Satisfaction Questionnaire (CSQ) is an 8-item measure that assesses how successful the patient perceived treatment to be. Average scores range from 1 - 4, with higher scores indicating higher satisfaction and perceived efficacy.
post treatment (week 17)
Perceived efficacy of treatment, as assessed by the CSQ
The Client Satisfaction Questionnaire (CSQ) is an 8-item measure that assesses how successful the patient perceived treatment to be. Average scores range from 1 - 4, with higher scores indicating higher satisfaction and perceived efficacy.
1 year follow-up
Perceived efficacy of treatment, as assessed by the TSPE.
One item from the Treatment Suitability and Patient Expectancy (TSPE) survey will assess how successful the patient perceived treatment to be. This item ranges from 0 - 10, with higher scores indicating higher perceived efficacy.
1 year follow-up
Perceived feasibility of treatment, as assessed by the TSPE.
One item from the Treatment Suitability and Patient Expectancy (TSPE) survey will assess how feasible the patient perceived treatment to be. This item ranges from 0 - 10, with higher scores indicating higher feasibility.
post treatment (week 17)
Perceived feasibility of treatment, as assessed by the CSQ.
Two items from the 8-item Client Satisfaction Questionnaire (CSQ) will assess how suitable/feasible treatment was based on the patient's needs, family dynamics, schedule constraints, etc. Average scores range from 1 - 4, with higher scores indicating higher feasibility.
post treatment (week 17)
Study Arms (2)
FBT
EXPERIMENTAL10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.
CBT-E
EXPERIMENTAL10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.
Interventions
10 families will be randomized to receive 10 - 16 weeks of Family Based Treatment (FBT), the "gold standard" in eating disorder treatment for adolescents. FBT is a highly structured behavioral intervention in which caregivers are charged with the primary task of re-feeding their child and normalizing his or her eating behaviors and weight status.
10 families will be randomized to receive 10 - 16 weeks of Enhanced Cognitive Behavioral Therapy (CBT-E), a clinically validated treatment for adolescent eating disorders. CBT-E is a short-term, individual treatment focused on normalizing eating behaviors and modifying underlying cognitions that contribute to the maintenance of eating disorder behaviors (e.g., over-importance of shape and weight in one's self-evaluation).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Weight Control & Diabetes Research Center
Providence, Rhode Island, 02903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea B. Goldschmidt, Ph.D.
Weight Control & Diabetes Research Center
- PRINCIPAL INVESTIGATOR
Christina Tortolani, Ph.D.
Rhode Island College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2019
First Posted
February 26, 2019
Study Start
January 1, 2019
Primary Completion
January 1, 2022
Study Completion
January 1, 2022
Last Updated
February 23, 2021
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share