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

Mount Sinai Health System logo

Mount Sinai Health System

Status

Completed

Conditions

Eating Disorders

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00418977
DSIR 84-CTS
K23MH074506 (U.S. NIH Grant/Contract)
GCO 04-0978

Details and patient eligibility

About

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

Full 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.

Enrollment

59 patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

59 participants in 2 patient groups

Family Based Therapy
Experimental group
Description:
Participants will receive family based therapy (FBT)
Treatment:
Behavioral: Family-Based Therapy ("Maudsley Method")
Individual Supportive Psychotherapy
Active Comparator group
Description:
Participants will receive individual supportive psychotherapy (ISP)
Treatment:
Behavioral: Individual Supportive Psychotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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