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Clinical Trials/NCT00418977
NCT00418977CompletedNot Applicable

Early Identification and Treatment of Anorexia Nervosa

Icahn School of Medicine at Mount Sinai1 site in 1 country59 target enrollmentStarted: September 1, 2005Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
59
Locations
1
Primary Endpoint
Body Mass Index (BMI) Z-score

Study Overview

Brief Summary

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
10 Years to 17 Years (Child)
Sex
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

Arms & Interventions

Family Based Therapy

Experimental

Participants will receive family based therapy (FBT)

Intervention: Family-Based Therapy ("Maudsley Method") (Behavioral)

Individual Supportive Psychotherapy

Active Comparator

Participants will receive individual supportive psychotherapy (ISP)

Intervention: Individual Supportive Psychotherapy (Behavioral)

Outcomes

Primary Outcomes

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 Outcomes

  • Height(up to 1 year)
  • Weight(up to 1 year)
  • BMI(up to 1 year)
  • BMI Percentile(up to 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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