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

Not Applicable

Completed

Conditions: Eating Disorders

Interventions: Behavioral: Individual Supportive Psychotherapy
Behavioral: Family-Based Therapy ("Maudsley Method")

Registration Number: NCT00418977

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 59

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual Supportive Psychotherapy	Individual Supportive Psychotherapy	Participants will receive individual supportive psychotherapy (ISP)
Family Based Therapy	Family-Based Therapy ("Maudsley Method")	Participants will receive family based therapy (FBT)

Primary Outcome Measures

Name	Time	Method
Body Mass Index (BMI) Z-score	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

Name	Time	Method
Height	up to 1 year	This variable informs the calculation of the outcome variable of BMI Z-score.
Weight	up to 1 year	This variable informs the calculation of the outcome variable of BMI Z-score.
BMI	up to 1 year	body mass index. This variable informs the calculation of the outcome variable of BMI Z-score.
BMI Percentile	up to 1 year	Body Mass Index (BMI) percentile. This is not a primary outcome variable.