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Comparing the Effectiveness of Two Therapies to Treat Signs of Anorexia Nervosa in Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00418977
Recruitment Status : Completed
First Posted : January 5, 2007
Results First Posted : April 28, 2014
Last Update Posted : December 23, 2015
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:
This study will compare the effectiveness of two therapies to treat early signs of anorexia nervosa in adolescents.

Condition or disease Intervention/treatment Phase
Eating Disorders Behavioral: Family-Based Therapy ("Maudsley Method") Behavioral: Individual Supportive Psychotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Identification and Treatment of Anorexia Nervosa
Study Start Date : September 2005
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
Experimental: Family Based Therapy
Participants will receive family based therapy (FBT)
Behavioral: Family-Based Therapy ("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.
Other Names:
  • FBT
  • Maudsley Method

Active Comparator: Individual Supportive Psychotherapy
Participants will receive individual supportive psychotherapy (ISP)
Behavioral: Individual Supportive Psychotherapy
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.
Other Name: ISP

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Height [ Time Frame: up to 1 year ]
    This variable informs the calculation of the outcome variable of BMI Z-score.

  2. Weight [ Time Frame: up to 1 year ]
    This variable informs the calculation of the outcome variable of BMI Z-score.

  3. BMI [ Time Frame: up to 1 year ]
    body mass index. This variable informs the calculation of the outcome variable of BMI Z-score.

  4. BMI Percentile [ Time Frame: up to 1 year ]
    Body Mass Index (BMI) percentile. This is not a primary outcome variable.

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00418977

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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute of Mental Health (NIMH)
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Principal Investigator: Katharine Loeb, PhD Icahn School of Medicine at Mount Sinai
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Icahn School of Medicine at Mount Sinai Identifier: NCT00418977    
Other Study ID Numbers: GCO 04-0978
K23MH074506 ( U.S. NIH Grant/Contract )
First Posted: January 5, 2007    Key Record Dates
Results First Posted: April 28, 2014
Last Update Posted: December 23, 2015
Last Verified: November 2015
Keywords provided by Icahn School of Medicine at Mount Sinai:
Anorexia Nervosa
Additional relevant MeSH terms:
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Feeding and Eating Disorders
Anorexia Nervosa
Mental Disorders
Signs and Symptoms, Digestive