James Lock
Study of Treatment for Adolescents with Bulimia Nervosa
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
In the face of scant literature on the subject, we aim to more clearly identify effective treatments for adolescent bulimia nervosa (BN) through a treatment study comparing two current treatments (Cognitive Behavioral Therapy for Adolescents, CBT-A and Family Based Therapy for Bulimia Nervosa, FBT-BN) for the disorder in comparison with a non-specific therapy, Supportive Psychotherapy for Adolescent Bulimia (SPT). Additionally, we hope to provide clinicians with information on treatment efficacy, variables that might influence outcome, and processes that may affect treatment efficacy that will guide them in their efforts to treat adolescent BN.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Behavior: Cognitive Behavioral Therapy for Adolescents
- Behavior: Supportive Psychotherapy
- Behavior: Family Based Therapy for Bulimia Nervosa
Phase:
N/AEligibility
Ages Eligible for Study:
12 years to 18 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Participants will be adolescents living with at least one of their parents and between the ages of 12 and 18 years of age with a DSM IV diagnosis of BN or partial BN (binge eating and purging at least one time per week over a six month period).
Males meeting inclusion criteria will also be entered into the study. They must have age-adjusted BMI greater than 17.5, or ideal body weight (IBW) > 85%. Family, for the purposes of this study, includes members of the subject?s household, including at least one parent or adult guardian. Single parent families, divorced families, step-parents, and other types of families will be allowed to enter the study.
Key Exclusion Criteria:
Potential participants will be excluded if any of the following characteristics are present:
1) psychotic illness or other mental illness requiring hospitalization; bipolar I disorder, depression with active suicidal thoughts and behavior;
2) associated physical illness that necessitates hospitalization;
3) current dependence on drugs or alcohol;
4) current diagnosis of anorexia nervosa or weight less that 85% IBW;
5) physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight;
6) currently taking medication for co-morbid conditions for less than 2-months;
7) currently taking medications that may induce weight loss, e.g., appetite suppressants such as sibutramine, phentermine, and xenical, unless the participant is willing to withdraw from such medications;
8) currently taking medications for symptoms of BN and unwilling to discontinue these prior to initiating treatment in the study
9) previous CBT or FBT treatment for BN
10) married subjects
11) emancipated minors
12) family members will be excluded from engaging in treatment for the following reasons:
a) Current or history of sexual or physical abuse of the patient by family members. Perpetrators of the abuse will be excluded from treatment. Should sexual or physical abuse by a family member occur during the course of treatment, perpetrators will be excluded from ongoing treatment.
b) Substance dependence, psychosis, or severe medical illness that would limit full participation in therapy, or that might put the family member at risk for worsening of their condition during treatment. The decision whether or not to allow these individuals to continue to participate in treatment will be made by the therapist in consultation with the treatment supervisor.
Additional Study Details
Official Title:
Treatment of Bulimic AdolescentsAnticipated start date:
1/15/2009Lead Sponsor:
Stanford UniversityCollaborator(s):
- University of Chicago
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
EfficacyPrimary Outcomes:
- Binge and purge frequency as assessed by the Eating Disorder Examination (EDE)
Secondary Outcomes:
- Changes in the subscale scores of the EDE
Total Number to be Enrolled:
158Total Number to be Enrolled at Stanford:
79More Information
Secondary ID(s):
- eProtocol Number 132056
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
3/20/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
Help