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

This study is currently recruiting participants.
Study NCT00418977.   Last updated on March 3, 2008.   Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Comparing the Effectiveness of Two Therapies to Treat Signs of Anorexia Nervosa in Adolescents
Official Title  Early Identification and Treatment of Anorexia Nervosa
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 Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Diagnostic criteria of anorexia nervosa [ Time Frame: Measured at pre-treatment, post-treatment, and 6 and 12 months post-treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measure 
Condition  Eating Disorders
Intervention  Behavioral: Family-Based Therapy ("Maudsley Method")
Behavioral: Individual Supportive Psychotherapy
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  60
Start Date  September 2005
Completion Date August 2010
Eligibility 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
Gender Both
Ages 10 Years to 17 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Lauren Alfano         lauren.alfano@mssm.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00418977
Organization ID K23 MH074506
Secondary IDs †† DSIR 84-CTS
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Katharine Loeb, PhD     Mount Sinai School of Medicine    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date March 2008
First Received Date  January 3, 2007
Last Updated Date March 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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