Eating DisorderNCT03599921
Treatment Outcome in Eating Disorders
An observational study of Eating Disorder, run by Children's Hospitals and Clinics of Minnesota.
Trial summary
Do the current eating disorder treatments, i.e., Family-based Treatment (FBT) and Enhanced Cognitive behavioral therapy (CBT-E), offered at the Center for the Treatment of Eating Disorders (CTED) demonstrate effectiveness? Specifically, which type of treatment is most effective for which diagnoses? Participants with… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Eating Disorder
- What is being tested?
- Family-based treatment, Enhanced Cognitive behavioral therapy and Family-based treatment modified for ARFID
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 275 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2015to 1 Jan 2021
- Phase
- Observational
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The investigators plan to enroll 1000 patients, both male and female, ages 6 to adult (18 and older) over a 5 year period. Patients who have been given a Diagnostic and Statistical Manual, 5th Edition (DSM-5) eating disorder diagnosis, and who are seeking outpatient treatment will all be approached for consent to participate in this study.
Who may be able to join
- Patients must be at least 6 years of age, attending the CTED clinic for outpatient treatment of a Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosed eating disorder in order to be included in this study.
Who cannot join
- Participants who are receiving inpatient services only and will not return to CTED for outpatient treatment.
- Participants with a co-morbid medical disorder known to influence eating or weight.
- Participants presenting with a significant psychotic disorder.
- Participants who are acutely suicidal.
- Participants who demonstrate significant substance abuse and/or substance dependence.
About this study
Do the current eating disorder treatments, i.e., Family-based Treatment (FBT) and Enhanced Cognitive behavioral therapy (CBT-E), offered at the Center for the Treatment of Eating Disorders (CTED) demonstrate effectiveness? Specifically, which type of treatment is most effective for which diagnoses? Participants with Anorexia Nervosa (AN), Bulimia Nervosa (BN), Other Specified Feeding or Eating Disorder (OSFED), or Unspecified Feeding or Eating Disorder (UFED) in this study will self select one of the two treatment groups, FBT or CBT-E.
Additionally, does Family-based Treatment (FBT) modified for Avoidant/Restrictive Food Intake Disorder (ARFID) and Family-based Treatment (FBT) combined with the Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders (FBT+UP for ARFID) demonstrate effectiveness for patients with an Avoidant/Restrictive Food Intake Disorder (ARFID) diagnosis?
Read the detailed description
Given a significant number of patients who presented for treatment at the Center for the Treatment of Eating Disorders (CTED) and were enrolled in this effectiveness study met criteria for a diagnosis of Avoidant/Restrictive Food Intake Disorder (ARFID), and because there are currently no randomized control trials systematically evaluating children/adolescents with ARFID, a secondary aim was added to this study.
The secondary aim will evaluate the preliminary effectiveness of two treatment groups including: Family-based Treatment (FBT) modified for ARFID and Family-based Treatment (FBT) combined with the Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders (FBT+UP for ARFID) for ARFID patients.
- Conditions
- Eating Disorder
- Being tested
- Family-based treatment, Enhanced Cognitive behavioral therapy, Family-based treatment modified for ARFID, FBT + UP for ARFID
- Keywords
- Family-based Treatment, Enhanced Cognitive Behavioral Therapy, Anorexia Nervosa, Other Specified Feeding or Eating Disorder, Bulimia Nervosa, Unspecified Feeding or Eating Disorder, Avoidant/Restrictive Food Intake Disorder, Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Avoidant Restrictive Food Intake Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based treatmentBehavioural
Family-based treatment, or FBT, is the leading evidenced based therapy for children and adolescents with an eating disorder.
The treatment is a talking type of treatment that involves the whole family and primarily focuses on helping parents play an active and positive role in helping to restore the patient's weight, then hand control of eating back to the patient as is age appropriate. Toward the end of treatment, it is concerned with developmental issues that may have been impacted by the illness.
Enhanced Cognitive behavioral therapyBehavioural
Enhanced Cognitive behavioral therapy, or CBT-E, is a leading evidence based treatment for adolescents and adults with an eating disorder.
The treatment is a one-to-one talking type of treatment that primarily focuses on what is keeping the eating problem going. It is therefore mainly concerned with the present and the future. It addresses the origins of the problem as needed.
Family-based treatment modified for ARFIDBehavioural
Family-based treatment modified for individuals with an ARFID diagnosis is a proposed therapy for treating ARFID.
The treatment is a talking type of treatment that involves the whole family and primarily focuses on helping parents play an active and positive role in helping to restore patient's weight and variety in eating, as needed.
FBT + UP for ARFIDBehavioural
Family-based treatment combined with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents is a proposed therapy for treating ARFID.
The treatment is a talking type of treatment that involves the whole family and begins with focus on psychoeducation, family engagement, and weight gain as needed. The Unified Protocol is then added to build skills that empower the patient to cope with difficult emotions, address avoidance, and increase tolerance of emotions or disgust responses.
| Study group | Role | What they receive |
|---|---|---|
| Family-based Treatment | Participants will receive family-based treatment. Receives: Behavioral: Family-based treatment | |
| Enhanced Cognitive behavioral therapy | Participants will receive enhance cognitive behavioral therapy. Receives: Behavioral: Enhanced Cognitive behavioral therapy | |
| Family-based Treatment for ARFID | Participants will receive family-based treatment modified for Avoidant/Restrictive Food Intake Disorder (ARFID). Receives: Behavioral: Family-based treatment modified for ARFID | |
| FBT + UP for ARFID | Participants will receive family-based treatment with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents, named FBT + UP for ARFID. Receives: Behavioral: FBT + UP for ARFID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapy effectiveness
- Evaluate which therapies work effectively for the treatment of eating disorders, and which types of treatments are most effective for specific diagnoses.
Measured: Measured at end of treatment (an average of 6-9 months) and at 6 and 12 month follow-up.
Secondary outcomes (1)
Treatment moderators
- Explore predictors and moderators of treatment outcome.
Measured: Measured at end of treatment (an average of 6-9 months) and at 6 and 12 month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start6 May 2015
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Sarah Eckhardt, Children's Hospitals and Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599921
- Sponsor's protocol ID
- 47919
- Status last verified
- Jul 2021
- First submitted
- 18 May 2018
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Le Grange D, Eckhardt S, Dalle Grave R, Crosby RD, Peterson CB, Keery H, Lesser J, Martell C. Enhanced cognitive-behavior therapy and family-based treatment for adolescents with an eating disorder: a non-randomized effectiveness trial. Psychol Med. 2022 Oct;52(13):2520-2530. doi: 10.1017/S0033291720004407. Epub 2020 Dec 3.
PubMed 33267919
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcome in Eating Disorders
- ClinicalTrials.gov ID
- NCT03599921
- Acronym / sponsor ID
- 47919
- Conditions
- Eating Disorder
- Keywords
- Family-based Treatment, Enhanced Cognitive Behavioral Therapy, Anorexia Nervosa, Other Specified Feeding or Eating Disorder, Bulimia Nervosa, Unspecified Feeding or Eating Disorder, Avoidant/Restrictive Food Intake Disorder, Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 6 May 2015 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 26 Jul 2018 (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.
Do the current eating disorder treatments, i.e., Family-based Treatment (FBT) and Enhanced Cognitive behavioral therapy (CBT-E), offered at the Center for the Treatment of Eating Disorders (CTED) demonstrate effectiveness? Specifically, which type of treatment is most effective for which diagnoses? Participants with Anorexia Nervosa (AN), Bulimia Nervosa (BN), Other Specified Feeding or Eating Disorder (OSFED), or Unspecified Feeding or Eating Disorder (UFED) in this study will self select one of the two treatment groups, FBT or CBT-E.
Additionally, does Family-based Treatment (FBT) modified for Avoidant/Restrictive Food Intake Disorder (ARFID) and Family-based Treatment (FBT) combined with the Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders (FBT+UP for ARFID) demonstrate effectiveness for patients with an Avoidant/Restrictive Food Intake Disorder (ARFID) diagnosis?
Detailed description
Given a significant number of patients who presented for treatment at the Center for the Treatment of Eating Disorders (CTED) and were enrolled in this effectiveness study met criteria for a diagnosis of Avoidant/Restrictive Food Intake Disorder (ARFID), and because there are currently no randomized control trials systematically evaluating children/adolescents with ARFID, a secondary aim was added to this study.
The secondary aim will evaluate the preliminary effectiveness of two treatment groups including: Family-based Treatment (FBT) modified for ARFID and Family-based Treatment (FBT) combined with the Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders (FBT+UP for ARFID) for ARFID patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Family-based Treatment | – | Behavioral: Family-based treatmentParticipants will receive family-based treatment. |
| Enhanced Cognitive behavioral therapy | – | Behavioral: Enhanced Cognitive behavioral therapyParticipants will receive enhance cognitive behavioral therapy. |
| Family-based Treatment for ARFID | – | Behavioral: Family-based treatment modified for ARFIDParticipants will receive family-based treatment modified for Avoidant/Restrictive Food Intake Disorder (ARFID). |
| FBT + UP for ARFID | – | Behavioral: FBT + UP for ARFIDParticipants will receive family-based treatment with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents, named FBT + UP for ARFID. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators plan to enroll 1000 patients, both male and female, ages 6 to adult (18 and older) over a 5 year period. Patients who have been given a Diagnostic and Statistical Manual, 5th Edition (DSM-5) eating disorder diagnosis, and who are seeking outpatient treatment will all be approached for consent to participate in this study.
Key inclusion criteria (1 listed)
- Patients must be at least 6 years of age, attending the CTED clinic for outpatient treatment of a Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosed eating disorder in order to be included in this study.
Key exclusion criteria (5 listed)
- Participants who are receiving inpatient services only and will not return to CTED for outpatient treatment.
- Participants with a co-morbid medical disorder known to influence eating or weight.
- Participants presenting with a significant psychotic disorder.
- Participants who are acutely suicidal.
- Participants who demonstrate significant substance abuse and/or substance dependence.
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 treatmentFamily-based treatment, or FBT, is the leading evidenced based therapy for children and adolescents with an eating disorder. The treatment is a talking type of treatment that involves the whole family and primarily focuses on helping parents play an active and positive role in helping to restore the patient's weight, then hand control of eating back to the patient as is age appropriate. Toward the end of treatment, it is concerned with developmental issues that may have been impacted by the illness. | Behavioural | Family-based Treatment |
| Enhanced Cognitive behavioral therapyEnhanced Cognitive behavioral therapy, or CBT-E, is a leading evidence based treatment for adolescents and adults with an eating disorder. The treatment is a one-to-one talking type of treatment that primarily focuses on what is keeping the eating problem going. It is therefore mainly concerned with the present and the future. It addresses the origins of the problem as needed. | Behavioural | Enhanced Cognitive behavioral therapy |
| Family-based treatment modified for ARFIDFamily-based treatment modified for individuals with an ARFID diagnosis is a proposed therapy for treating ARFID. The treatment is a talking type of treatment that involves the whole family and primarily focuses on helping parents play an active and positive role in helping to restore patient's weight and variety in eating, as needed. | Behavioural | Family-based Treatment for ARFID |
| FBT + UP for ARFIDFamily-based treatment combined with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents is a proposed therapy for treating ARFID. The treatment is a talking type of treatment that involves the whole family and begins with focus on psychoeducation, family engagement, and weight gain as needed. The Unified Protocol is then added to build skills that empower the patient to cope with difficult emotions, address avoidance, and increase tolerance of emotions or disgust responses. | Behavioural | FBT + UP for ARFID |
Primary outcome
Therapy effectiveness
Time frame: Measured at end of treatment (an average of 6-9 months) and at 6 and 12 month follow-up.
1) Evaluate which therapies work effectively for the treatment of eating disorders, and which types of treatments are most effective for specific diagnoses.
1 secondary outcome
Treatment moderators
Time frame: Measured at end of treatment (an average of 6-9 months) and at 6 and 12 month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Derived from this study: PubMed 33267919Le Grange D, Eckhardt S, Dalle Grave R, Crosby RD, Peterson CB, Keery H, Lesser J, Martell C. Enhanced cognitive-behavior therapy and family-based treatment for adolescents with an eating disorder: a non-randomized effectiveness trial. Psychol Med. 2022 Oct;52(13):2520-2530. doi: 10.1017/S0033291720004407. Epub 2020 Dec 3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorder, run by Children's Hospitals and Clinics of Minnesota.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapy effectiveness (time frame: Measured at end of treatment (an average of 6-9 months) and at 6 and 12 month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03599921, which also lists 1 linked publication.
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 28 Jul 2021.