Eating DisordersNCT00418977
Comparing the Effectiveness of Two Therapies to Treat Signs of Anorexia Nervosa in Adolescents
A study testing Family-Based Therapy ("Maudsley Method") and Individual Supportive Psychotherapy in people with Eating Disorders, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study will compare the effectiveness of two therapies to treat early signs of anorexia nervosa in adolescents. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Family-Based Therapy ("Maudsley Method") and Individual Supportive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Living with family or guardian
- Medically stable for outpatient treatment
- Meets two to three criteria for anorexia nervosa
- Receiving a stable dose of psychotropic medication (if applicable)
Who cannot join
- Meets DSM-IV criteria for anorexia nervosa
- Current psychotic illness, alcohol or drug dependence, or medical or physical conditions known to influence eating, weight, or menstrual status
- Previous participation in study treatment
- Unable to withdraw from current psychological treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Early Identification and Treatment of Anorexia Nervosa
This study will compare the effectiveness of two therapies to treat early signs of anorexia nervosa in adolescents.
Read the detailed description
Eating disorders often result in serious illness and can lead to prolonged health complications, including heart and kidney problems, digestive disorders, nerve damage, and low blood pressure. Anorexia nervosa is a type of eating disorder in which a person does not eat enough for fear of becoming overweight, resulting in extreme weight loss. Women are at a greater risk of developing this disease, particularly when they are between the ages of 12 and 24. Treatments for anorexia nervosa typically include nutrition counseling, psychotherapy, and medication. The purpose of this study is to compare the effectiveness of two therapies to treat adolescents who have signs of anorexia nervosa but have not fully developed the disease.
Potential participants will attend 2 screening visits during which parents and children will complete separate questionnaires and undergo 3 interviews regarding eating behaviors and changes in mood. Once screening evaluations have been completed, eligible participants will be randomly assigned to 1 of 2 treatment groups. Participants assigned to the first group will receive 14 family therapy sessions. All family members living with the child will be asked to attend these sessions with the child. Family members will learn strategies to help the child eat enough at home and will address various issues concerning family relationships. Children will learn how to eat well on their own and will also discuss topics related to family dynamics. Participants assigned to the second group will receive 14 individual therapy sessions that will focus on the child and not include family members. Before each treatment session, parents will speak with the therapist to discuss progress and any new concerns or issues regarding the child's condition. The therapist will then work directly with the child to discuss what may be causing the child's signs of anorexia nervosa and how to handle difficult emotions associated with the disorder. Participants in both treatment groups will attend 1-hour therapy sessions that will occur weekly for 8 sessions, then biweekly for 4 sessions, and monthly for the last 2 sessions. Evaluations, lasting 3 to 4 hours, will occur before treatment begins, immediately following treatment, and 6 and 12 months post-treatment. Evaluations will consist of interviews and questionnaires used to assess whether treatment was effective in preventing participants from developing anorexia nervosa.
- Conditions
- Eating Disorders
- Being tested
- Family-Based Therapy ("Maudsley Method"), Individual Supportive Psychotherapy
- Keywords
- Anorexia Nervosa
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-Based Therapy ("Maudsley Method")Behavioural
Also called FBT, Maudsley Method
The goal of FBT is to resolve the eating disorder and return the patient to healthy psychosocial and physiological development through active family involvement across three treatment phases. In Phase I, therapy is focused on the disordered eating. The therapist primarily makes careful, persistent requests for united parental action toward re-feeding and/or regulating eating habits and directs the discussion so as to create and reinforce a strong parental alliance around their efforts at feeding their child. In Phase II, the goal is to gradually transfer control over eating back to the participant, with the parents still maintaining general oversight and responsibility for continued progression toward healthy habits. In Phase III, the central goal is establishment of a healthy child or adolescent relationship with the parents where disordered eating is not the basis of interaction.
Individual Supportive PsychotherapyBehavioural
Also called ISP
The goal of ISP is for the patient to understand and address the psychological issues underlying the origin and maintenance of the eating disorder. This work is done directly with the child/adolescent. In this treatment, eating disorders are seen as complicated (e.g., they tend to mask other underlying difficulties). In Phase I, the aims are to establish a sound therapeutic relationship, obtain a comprehensive description of the eating problem and its development, identify underlying problems that might be responsible for the disordered eating, and inform the patient about the dangers of eating disorders. Phase II encourages participants to explore underlying emotional problems, facilitates self-disclosure and expression of feelings, and fosters independence. Phase III focuses on how other underlying issues might affect future adjustment.
| Study group | Role | What they receive |
|---|---|---|
| Family Based Therapy | Experimental | Participants will receive family based therapy (FBT) Receives: Behavioral: Family-Based Therapy ("Maudsley Method") |
| Individual Supportive Psychotherapy | Active comparator | Participants will receive individual supportive psychotherapy (ISP) Receives: Behavioral: Individual Supportive Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI) Z-score
Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator
Measured: up to 1 year
Secondary outcomes (4)
Height
This variable informs the calculation of the outcome variable of BMI Z-score.
Measured: up to 1 year
Weight
This variable informs the calculation of the outcome variable of BMI Z-score.
Measured: up to 1 year
BMI
body mass index. This variable informs the calculation of the outcome variable of BMI Z-score.
Measured: up to 1 year
BMI Percentile
Body Mass Index (BMI) percentile. This is not a primary outcome variable.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startSep 2005
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Katharine Loeb, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418977
- Sponsor's protocol ID
- GCO 04-0978
- Other IDs
- K23MH074506, DSIR 84-CTS
- Status last verified
- Nov 2015
- First submitted
- 3 Jan 2007
- Last updated
- 23 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Drury CR, Hail L, Rienecke RD, Accurso EC, Coelho JS, Lock J, Le Grange D, Loeb KL. Psychometric properties of the Parent Eating Disorder Examination Questionnaire. Int J Eat Disord. 2023 Sep;56(9):1730-1742. doi: 10.1002/eat.23999. Epub 2023 May 29.
PubMed 37248808Loeb KL, Weissman RS, Marcus S, Pattanayak C, Hail L, Kung KC, Schron D, Zucker N, Le Grange D, Lock J, Newcorn JH, Taylor CB, Walsh BT. Family-Based Treatment for Anorexia Nervosa Symptoms in High-Risk Youth: A Partially-Randomized Preference-Design Study. Front Psychiatry. 2020 Jan 22;10:985. doi: 10.3389/fpsyt.2019.00985. eCollection 2019.
PubMed 32038326
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification and Treatment of Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT00418977
- Acronym / sponsor ID
- GCO 04-0978
- Conditions
- Eating Disorders
- Keywords
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2005
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 5 Jan 2007 (estimated)
- Results
- Posted 28 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the effectiveness of two therapies to treat early signs of anorexia nervosa in adolescents.
Detailed description
Eating disorders often result in serious illness and can lead to prolonged health complications, including heart and kidney problems, digestive disorders, nerve damage, and low blood pressure. Anorexia nervosa is a type of eating disorder in which a person does not eat enough for fear of becoming overweight, resulting in extreme weight loss. Women are at a greater risk of developing this disease, particularly when they are between the ages of 12 and 24. Treatments for anorexia nervosa typically include nutrition counseling, psychotherapy, and medication. The purpose of this study is to compare the effectiveness of two therapies to treat adolescents who have signs of anorexia nervosa but have not fully developed the disease.
Potential participants will attend 2 screening visits during which parents and children will complete separate questionnaires and undergo 3 interviews regarding eating behaviors and changes in mood. Once screening evaluations have been completed, eligible participants will be randomly assigned to 1 of 2 treatment groups. Participants assigned to the first group will receive 14 family therapy sessions. All family members living with the child will be asked to attend these sessions with the child. Family members will learn strategies to help the child eat enough at home and will address various issues concerning family relationships. Children will learn how to eat well on their own and will also discuss topics related to family dynamics. Participants assigned to the second group will receive 14 individual therapy sessions that will focus on the child and not include family members. Before each treatment session, parents will speak with the therapist to discuss progress and any new concerns or issues regarding the child's condition. The therapist will then work directly with the child to discuss what may be causing the child's signs of anorexia nervosa and how to handle difficult emotions associated with the disorder. Participants in both treatment groups will attend 1-hour therapy sessions that will occur weekly for 8 sessions, then biweekly for 4 sessions, and monthly for the last 2 sessions. Evaluations, lasting 3 to 4 hours, will occur before treatment begins, immediately following treatment, and 6 and 12 months post-treatment. Evaluations will consist of interviews and questionnaires used to assess whether treatment was effective in preventing participants from developing anorexia nervosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Based Therapy | Experimental | Behavioral: Family-Based Therapy ("Maudsley Method")Participants will receive family based therapy (FBT) |
| Individual Supportive Psychotherapy | Active comparator | Behavioral: Individual Supportive PsychotherapyParticipants will receive individual supportive psychotherapy (ISP) |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Living with family or guardian
- Medically stable for outpatient treatment
- Meets two to three criteria for anorexia nervosa
- Receiving a stable dose of psychotropic medication (if applicable)
Key exclusion criteria (4 listed)
- Meets DSM-IV criteria for anorexia nervosa
- Current psychotic illness, alcohol or drug dependence, or medical or physical conditions known to influence eating, weight, or menstrual status
- Previous participation in study treatment
- Unable to withdraw from current psychological treatment
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 Therapy ("Maudsley Method")Also: FBT, Maudsley MethodThe goal of FBT is to resolve the eating disorder and return the patient to healthy psychosocial and physiological development through active family involvement across three treatment phases. In Phase I, therapy is focused on the disordered eating. The therapist primarily makes careful, persistent requests for united parental action toward re-feeding and/or regulating eating habits and directs the discussion so as to create and reinforce a strong parental alliance around their efforts at feeding their child. In Phase II, the goal is to gradually transfer control over eating back to the participant, with the parents still maintaining general oversight and responsibility for continued progression toward healthy habits. In Phase III, the central goal is establishment of a healthy child or adolescent relationship with the parents where disordered eating is not the basis of interaction. | Behavioural | Family Based Therapy |
| Individual Supportive PsychotherapyAlso: ISPThe goal of ISP is for the patient to understand and address the psychological issues underlying the origin and maintenance of the eating disorder. This work is done directly with the child/adolescent. In this treatment, eating disorders are seen as complicated (e.g., they tend to mask other underlying difficulties). In Phase I, the aims are to establish a sound therapeutic relationship, obtain a comprehensive description of the eating problem and its development, identify underlying problems that might be responsible for the disordered eating, and inform the patient about the dangers of eating disorders. Phase II encourages participants to explore underlying emotional problems, facilitates self-disclosure and expression of feelings, and fosters independence. Phase III focuses on how other underlying issues might affect future adjustment. | Behavioural | Individual Supportive Psychotherapy |
Primary outcome
Body Mass Index (BMI) Z-score
Time frame: up to 1 year
Z-score was calculated using the Baylor College of Medicine Children's Nutrition Research Center's online BMI calculator
4 secondary outcomes
Height
Time frame: up to 1 year
Weight
Time frame: up to 1 year
BMI
Time frame: up to 1 year
BMI Percentile
Time frame: up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37248808Drury CR, Hail L, Rienecke RD, Accurso EC, Coelho JS, Lock J, Le Grange D, Loeb KL. Psychometric properties of the Parent Eating Disorder Examination Questionnaire. Int J Eat Disord. 2023 Sep;56(9):1730-1742. doi: 10.1002/eat.23999. Epub 2023 May 29.
- Derived from this study: PubMed 32038326Loeb KL, Weissman RS, Marcus S, Pattanayak C, Hail L, Kung KC, Schron D, Zucker N, Le Grange D, Lock J, Newcorn JH, Taylor CB, Walsh BT. Family-Based Treatment for Anorexia Nervosa Symptoms in High-Risk Youth: A Partially-Randomized Preference-Design Study. Front Psychiatry. 2020 Jan 22;10:985. doi: 10.3389/fpsyt.2019.00985. eCollection 2019.
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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.
Katharine Loeb, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-Based Therapy ("Maudsley Method") and Individual Supportive Psychotherapy in people with Eating Disorders, run by Icahn School of Medicine at Mount Sinai 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 4 inclusion and 4 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 23 Dec 2015. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Body Mass Index (BMI) Z-score (time frame: up to 1 year). 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 NCT00418977, which also lists 2 linked publications.
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 Dec 2015; AzTrials last refreshed its copy on 8 Nov 2026.