Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00418977
First received: January 3, 2007
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Eating Disorders
Behavioral: Family-Based Therapy ("Maudsley Method")
Behavioral: Individual Supportive Psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Identification and Treatment of Anorexia Nervosa

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Height [ Time Frame: post treatment ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: at post-treatment ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: at post-treatment ] [ Designated as safety issue: No ]
    body mass index

  • BMI Percentile [ Time Frame: at post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BMI Z Score [ Time Frame: at post treatment ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2005
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418977

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Katharine Loeb, PhD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00418977     History of Changes
Other Study ID Numbers: GCO 04-0978, K23MH074506, DSIR 84-CTS
Study First Received: January 3, 2007
Results First Received: March 10, 2014
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Anorexia Nervosa

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Eating Disorders
Mental Disorders
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 25, 2014