Project CORE: Disseminating Eating Disorders Treatment

Eating Disorders in Adolescence Clinical Trial

Official title:

Disseminating Eating Disorders Education and Treatment Across Multiple Levels of Care: Improving Access in the Rhode Island Medicaid Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03855553
• Other study ID #: 1319865
• Status: Recruiting
• Phase: Phase 1
• Start date: January 1, 2019
• Est. completion date: January 2022

Study information

• Verified date: August 2020
• Source: The Miriam Hospital
• Contact: Erin R. Stalvey
• Phone: (401) 793-8962
• Email: estalvey[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Anorexia Nervosa Restricting Type
• Anorexia Nervosa/Bulimia
• Bulimia
• Bulimia Nervosa
• Disease
• Eating Disorders in Adolescence
• Feeding and Eating Disorders

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	The Weight Control & Diabetes Research Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI percentile		post treatment (week 17)
Primary	BMI percentile		1 year follow up
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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)