Clinical Trials Logo

Clinical Trial Summary

The primary hypotheses are:

- A procedurally distinct family therapy is an effective and essential way to reduce bingeing and purging in adolescents with BN, and leads to the long-term amelioration of bulimic symptoms.

- Family therapy is an effective way to bring about meaningful improvements in family interaction.

- Family therapy will produce significantly larger reductions in bulimic symptoms and improved family interaction in adolescents with BN compared to a control supportive psychotherapy.


Clinical Trial Description

Bulimia nervosa (BN) is a disabling eating disorder and affects as many as 2% of young women. It is a major source of psychiatric and medical morbidity that often impairs several areas of functioning. Even more alarming is the fact that BN is occurring with increasing frequency among adolescents and preadolescents. Applying stringent diagnostic criteria for BN, studies have found 2-5% of adolescent girls surveyed qualify for diagnosis of BN. Research specific to treatment of child and adolescent eating disorders remains limited. No psychological treatment has been systematically evaluated in the treatment of adolescents with BN. However, a series of studies from the Maudsley Hospital in London have shown that family therapy (the 'Maudsley Approach') is effective in the treatment of adolescents with anorexia nervosa (AN). These studies have shown that involving the parents and siblings in treatment has beneficial effects on reversing the course of the eating disorder as well as improving family interaction. A preliminary report from the Maudsley group has also shown that the 'Maudsley Approach' may be helpful in the treatment of adolescents with BN. Because most young adolescents still live with their families of origin, this raises the interesting clinical question that adolescent BN patients can also be successfully treated with family therapy.

The proposed study has two specific aims:

1. To adapt and pilot a recently developed family therapy manual for adolescent AN for use in the treatment of adolescent BN patients.

2. To compare the efficacy of this conceptually and procedurally distinct family therapy treatment with individual control psychotherapy.

To achieve these aims, we propose a five-year controlled treatment study to be carried out at The University of Chicago. Eighty newly referred adolescent patients meeting DSM-IV diagnostic criteria for BN will be randomly allocated to one of two groups: 1) family therapy or 2) the individual supportive control treatment. All patients will receive the same medical evaluation and monitoring throughout the study period. Assessment of psychiatric and medical outcome measures will be carried out at the onset of treatment, during treatment, at the end of treatment, and again at one-year follow-up. The clinical outcome variables assessed will include the EDE, KSADS, RSE, and EE. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00518843
Study type Interventional
Source University of Chicago
Contact
Status Completed
Phase Phase 2
Start date April 2001
Completion date May 2006

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04174703 - Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing N/A
Terminated NCT04278755 - Binge Eating & Birth Control Phase 2
Withdrawn NCT02978742 - Evaluating and Implementing a Smartphone Application Treatment Program for Bulimia Nervosa and Binge Eating Disorder N/A
Withdrawn NCT00988481 - Topiramate Augmentation in Bulimia Nervosa Partial Responders Phase 4
Completed NCT00184301 - A Comparison Study of Treatments Given to Patients With Concurrent Eating Disorder and Personality Disorder. N/A
Completed NCT00522769 - Cognitive Behavioral Therapy to Treat Bulimia Nervosa in Adolescents Phase 1/Phase 2
Completed NCT00304187 - Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa Phase 2
Recruiting NCT04409457 - Self-Control in Bulimia Nervosa N/A
Recruiting NCT05509257 - Naltrexone Neuroimaging in Teens With Eating Disorders Early Phase 1
Recruiting NCT05862389 - Study on the Mechanism of Eating Disorder
Recruiting NCT05937243 - Identifying Effective Technological-based Augmentations to Enhance Outcomes From Self-help Cognitive Behavior Therapy for Binge Eating N/A
Recruiting NCT05728021 - Smartphone-based Aftercare for Inpatients With Bulimia Nervosa N/A
Completed NCT03781921 - The Neural Bases of Emotion Regulation in Bulimia Nervosa
Completed NCT02553824 - FDA Approved Medication to Reduce Binge Eating and/or Purging Phase 1
Terminated NCT04041024 - Decision-making and Risk-taking in Bulimia N/A
Completed NCT04265131 - Emotion Regulation in Eating Disorders: How Can Art Therapy Contribute to Treatment Outcome? N/A
Recruiting NCT06431854 - Evaluation of a New Treatment Program for Adolescents With Eating Disorders: MINERVA Program N/A
Recruiting NCT02960152 - Periodontal Impact of Eating Disorders (the PERIOED Study) N/A
Completed NCT00916071 - Association Between Attention Deficit Hyperactivity Disorder and Bulimia Nervosa in Outpatients With Eating Disorders N/A
Terminated NCT00308776 - Cholecystokinin for Reducing Binge Eating in People With Bulimia Nervosa N/A