Anorexia Nervosa/BulimiaPhase 1NCT03855553
Project CORE: Disseminating Eating Disorders Treatment
A Phase 1 study testing Family Based Treatment and Enhanced Cognitive Behavioral Therapy in people with Anorexia Nervosa/Bulimia and Anorexia Nervosa Restricting Type, run by The Miriam Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Anorexia Nervosa/Bulimia, Anorexia Nervosa Restricting Type, Eating Disorders in Adolescence
- What is being tested?
- Family Based Treatment and Enhanced Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Eva-Molly Dunbar contact
United States1 site, 1 recruiting
- Recruiting
The Weight Control & Diabetes Research Center
Providence, Rhode Island, 02903
Erin R. Stalvey, 401-793-8962, estalvey@lifespan.org
Eva-Molly Dunbar, epetittodunbar@my.uri.edu
About this study
Official title: Disseminating Eating Disorders Education and Treatment Across Multiple Levels of Care: Improving Access in the Rhode Island Medicaid Population
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.
Read the 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.
- Conditions
- Anorexia Nervosa/Bulimia, Anorexia Nervosa Restricting Type, Eating Disorders in Adolescence
- Being tested
- Family Based Treatment, Enhanced Cognitive Behavioral Therapy
- Keywords
- Anorexia Nervosa, Bulimia Nervosa, Eating Disorders, Adolescence, Clinical Training, Community Outreach, Family Based Treatment, Enhanced Cognitive Behavioral Therapy
- Medical subject headings
- Anorexia Nervosa, Bulimia, Bulimia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Based TreatmentBehavioural
Also called FBT
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 TherapyBehavioural
Also called CBT-E
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).
| Study group | Role | What they receive |
|---|---|---|
| FBT | Experimental | 10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent. Receives: Behavioral: Family Based Treatment |
| CBT-E | Experimental | 10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent. Receives: Behavioral: Enhanced Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI percentile
Measured: post treatment (week 17)
BMI percentile
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: post treatment (week 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 Jan 2019
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia Nervosa/BulimiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea B. Goldschmidt, Ph.D., Principal investigator, Weight Control & Diabetes Research CenterChristina Tortolani, Ph.D., Principal investigator, Rhode Island College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855553
- Sponsor's protocol ID
- 1319865
- Status last verified
- Aug 2020
- First submitted
- 21 Feb 2019
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disseminating Eating Disorders Education and Treatment Across Multiple Levels of Care: Improving Access in the Rhode Island Medicaid Population
- ClinicalTrials.gov ID
- NCT03855553
- Acronym / sponsor ID
- 1319865
- Conditions
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FBT | Experimental | Behavioral: Family Based Treatment10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent. |
| CBT-E | Experimental | Behavioral: Enhanced Cognitive Behavioral Therapy10 families will be randomized to receive 10 - 16 weeks of eating disorder treatment for their adolescent. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Based TreatmentAlso: FBT10 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. | Behavioural | FBT |
| Enhanced Cognitive Behavioral TherapyAlso: CBT-E10 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). | Behavioural | CBT-E |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva-Molly Dunbar contact
Andrea B. Goldschmidt, Ph.D. principal investigator
Weight Control & Diabetes Research Center
Christina Tortolani, Ph.D. principal investigator
Rhode Island College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Family Based Treatment and Enhanced Cognitive Behavioral Therapy in people with Anorexia Nervosa/Bulimia and Anorexia Nervosa Restricting Type, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erin R. Stalvey ((401) 793-8962, estalvey@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI percentile (time frame: post treatment (week 17)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.