- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00518843
Family Therapy for Adolescent Bulimia Nervosa
Family Therapy for Adolescent Bulimia Nervosa: A Controlled Comparison
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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:
- To adapt and pilot a recently developed family therapy manual for adolescent AN for use in the treatment of adolescent BN patients.
- 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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- The University of Chicago
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- DSM-IV criteria for bulimia nervosa or partial bulimia nervosa
Exclusion Criteria:
- psychotic illness acute suicidality medical illness that impacts weight pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: FBT-BN
Family-based treatment
|
Mobilizing parents to curtail binge eating and purging
|
|
Active Comparator: SPT
Individual Supportive Psychotherapy
|
Supportive the individual patient to explore factors that might underlie the eating disorder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Binge eating and purging frequency measured by the Eating Disorder Examination
Time Frame: 28 days
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
EDE Subscales
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel Le Grange, PhD, The University of Chiacgo
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10208 (K23 MH01923)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bulimia Nervosa
-
University of California, San DiegoActive, not recruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa | Atypical Bulimia NervosaUnited States
-
Istituto Auxologico ItalianoCatholic University of the Sacred Heart; University of Turin, Italy; Open University and other collaboratorsRecruitingAnorexia Nervosa/BulimiaItaly
-
University Hospital, ToulouseUnknownAnorexia Nervosa/BulimiaFrance
-
Maastricht UniversityZonMw: The Netherlands Organisation for Health Research and Development; Utrecht... and other collaboratorsRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa (Other Specified Eating Disorder) | Atypical Bulimia Nervosa (Other Specified Eating Disorder)Netherlands
-
University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia NervosaUnited States
-
Washington University School of MedicineNational Institute of Mental Health (NIMH)Completed
-
University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia NervosaUnited States
-
Rosemary Claire RodenChildren's Miracle NetworkTerminatedBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
-
Yeshiva UniversityYale UniversityCompletedAnorexia Nervosa | Bulimia Nervosa | Anorexia Nervosa, Atypical | Bulimia; AtypicalUnited States
-
Centre Hospitalier EsquirolNot yet recruitingAnorexia Nervosa | Hyperphagia | Eating Disorders | Boulimia NervosaFrance
Clinical Trials on FBT-BN
-
The University of Tennessee, KnoxvilleNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); The... and other collaboratorsCompleted
-
Stanford UniversityNational Institute of Mental Health (NIMH); University of California, San FranciscoCompletedOnline Training for TherapistsUnited States
-
Stanford UniversityNational Institute of Mental Health (NIMH)RecruitingAnorexia NervosaUnited States, Canada
-
Temple UniversityNational Institute of Mental Health (NIMH)Completed
-
Stanford UniversityNational Institutes of Health (NIH)CompletedOnline Training for TherapistsUnited States
-
Mayo ClinicNational Institute of Mental Health (NIMH)Enrolling by invitationEating DisordersUnited States
-
University of California, San DiegoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedPediatric ObesityUnited States
-
Stanford UniversityNational Institutes of Health (NIH)CompletedAnorexia NervosaUnited States
-
Mental Health Services in the Capital Region, DenmarkRecruitingEating DisordersDenmark
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States