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Project CORE: Disseminating Eating Disorders Treatment

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ClinicalTrials.gov Identifier: NCT03855553
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
The Miriam Hospital

Tracking Information
First Submitted Date  ICMJE February 21, 2019
First Posted Date  ICMJE February 26, 2019
Last Update Posted Date February 23, 2021
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2019)
  • BMI percentile [ Time Frame: post treatment (week 17) ]
  • BMI percentile [ Time Frame: 1 year follow up ]
  • Eating disorder symptomology, as assessed by the EDE-Q. [ Time Frame: post treatment (week 17) ]
    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.
  • Eating disorder symptomology, as assessed by the ED-15. [ Time Frame: post treatment (week 17) ]
    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.
  • Eating disorder symptomology, as assessed by EDE-Q [ Time Frame: 1 year follow-up ]
    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.
  • Eating disorder symptomology, as assessed by ED-15. [ Time Frame: 1 year follow-up ]
    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.
  • Perceived efficacy of treatment, as assessed by the TSPE [ Time Frame: post treatment (week 17) ]
    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.
  • Perceived efficacy of treatment, as assessed by the CSQ [ Time Frame: post treatment (week 17) ]
    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.
  • Perceived efficacy of treatment, as assessed by the CSQ [ Time Frame: 1 year follow-up ]
    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.
  • Perceived efficacy of treatment, as assessed by the TSPE. [ Time Frame: 1 year follow-up ]
    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.
  • Perceived feasibility of treatment, as assessed by the TSPE. [ Time Frame: post treatment (week 17) ]
    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.
  • Perceived feasibility of treatment, as assessed by the CSQ. [ Time Frame: post treatment (week 17) ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Project CORE: Disseminating Eating Disorders Treatment
Official Title  ICMJE Disseminating Eating Disorders Education and Treatment Across Multiple Levels of Care: Improving Access in the Rhode Island Medicaid Population
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anorexia Nervosa/Bulimia
  • Anorexia Nervosa Restricting Type
  • Eating Disorders in Adolescence
Intervention  ICMJE
  • Behavioral: Family Based Treatment
    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.
    Other Name: FBT
  • Behavioral: Enhanced Cognitive Behavioral Therapy
    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).
    Other Name: CBT-E
Study Arms  ICMJE
  • Experimental: FBT
    10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.
    Intervention: Behavioral: Family Based Treatment
  • Experimental: CBT-E
    10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.
    Intervention: Behavioral: Enhanced Cognitive Behavioral Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 25, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Erin R. Stalvey (401) 793-8962 estalvey@lifespan.org
Contact: Eva-Molly Dunbar epetittodunbar@my.uri.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03855553
Other Study ID Numbers  ICMJE 1319865
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The Miriam Hospital
Study Sponsor  ICMJE The Miriam Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrea B. Goldschmidt, Ph.D. Weight Control & Diabetes Research Center
Principal Investigator: Christina Tortolani, Ph.D. Rhode Island College
PRS Account The Miriam Hospital
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP