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Project CORE: Disseminating Eating Disorders Treatment

Primary Purpose

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

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Family Based Treatment
Enhanced Cognitive Behavioral Therapy
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa/Bulimia focused on measuring Anorexia Nervosa, Bulimia Nervosa, Eating Disorders, Adolescence, Clinical Training, Community Outreach, Family Based Treatment, Enhanced Cognitive Behavioral Therapy

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Weight Control & Diabetes Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FBT

CBT-E

Arm Description

10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.

10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.

Outcomes

Primary Outcome Measures

BMI percentile
BMI percentile
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 21, 2019
Last Updated
February 22, 2021
Sponsor
The Miriam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03855553
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FBT
Arm Type
Experimental
Arm Description
10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.
Arm Title
CBT-E
Arm Type
Experimental
Arm Description
10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.
Intervention Type
Behavioral
Intervention Name(s)
Family Based Treatment
Other Intervention Name(s)
FBT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT-E
Intervention Description
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).
Primary Outcome Measure Information:
Title
BMI percentile
Time Frame
post treatment (week 17)
Title
BMI percentile
Time Frame
1 year follow up
Title
Eating disorder symptomology, as assessed by the EDE-Q.
Description
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.
Time Frame
post treatment (week 17)
Title
Eating disorder symptomology, as assessed by the ED-15.
Description
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.
Time Frame
post treatment (week 17)
Title
Eating disorder symptomology, as assessed by EDE-Q
Description
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.
Time Frame
1 year follow-up
Title
Eating disorder symptomology, as assessed by ED-15.
Description
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.
Time Frame
1 year follow-up
Title
Perceived efficacy of treatment, as assessed by the TSPE
Description
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.
Time Frame
post treatment (week 17)
Title
Perceived efficacy of treatment, as assessed by the CSQ
Description
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.
Time Frame
post treatment (week 17)
Title
Perceived efficacy of treatment, as assessed by the CSQ
Description
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.
Time Frame
1 year follow-up
Title
Perceived efficacy of treatment, as assessed by the TSPE.
Description
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.
Time Frame
1 year follow-up
Title
Perceived feasibility of treatment, as assessed by the TSPE.
Description
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.
Time Frame
post treatment (week 17)
Title
Perceived feasibility of treatment, as assessed by the CSQ.
Description
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.
Time Frame
post treatment (week 17)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin R. Stalvey
Phone
(401) 793-8962
Email
estalvey@lifespan.org
First Name & Middle Initial & Last Name or Official Title & Degree
Eva-Molly Dunbar
Email
epetittodunbar@my.uri.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea B. Goldschmidt, Ph.D.
Organizational Affiliation
Weight Control & Diabetes Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christina Tortolani, Ph.D.
Organizational Affiliation
Rhode Island College
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Weight Control & Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin R. Stalvey
Phone
401-793-8962
Email
estalvey@lifespan.org
First Name & Middle Initial & Last Name & Degree
Eva-Molly Dunbar
Email
epetittodunbar@my.uri.edu
First Name & Middle Initial & Last Name & Degree
Andrea B. Goldschmidt, Ph.D.
First Name & Middle Initial & Last Name & Degree
Christina Tortolani, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Project CORE: Disseminating Eating Disorders Treatment

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