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Project CORE: Disseminating Eating Disorders Treatment

Phase 1
Conditions
Anorexia Nervosa/Bulimia
Eating Disorders in Adolescence
Anorexia Nervosa Restricting Type
Interventions
Behavioral: Enhanced Cognitive Behavioral Therapy
Behavioral: Family Based Treatment
Registration Number
NCT03855553
Lead Sponsor
The Miriam Hospital
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
20
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CBT-EEnhanced Cognitive Behavioral Therapy10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.
FBTFamily Based Treatment10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent.
Primary Outcome Measures
NameTimeMethod
BMI percentile1 year follow up
Eating disorder symptomology, as assessed by the ED-15.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 ED-15.1 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 CSQ1 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.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.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.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.

Eating disorder symptomology, as assessed by the EDE-Q.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.

Perceived efficacy of treatment, as assessed by the TSPEpost 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.

Eating disorder symptomology, as assessed by EDE-Q1 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The Weight Control & Diabetes Research Center

🇺🇸

Providence, Rhode Island, United States

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