Back to resultsCognitive Behavior Therapy for Adolescents With Bulimia
Primary Purpose
Bulimia Nervosa
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Bulimia Nervosa focused on measuring Bulimia Nervosa, EDNOS, Adolescents
Eligibility Criteria
Inclusion Criteria:
- Current or prior DSM IV diagnosis of Bulimia Nervosa or Sub-threshold Bulimia Nervosa (those who meet all DSM-IV criteria for BN, but engage in subjective binge-eating episodes and binge/purge at a frequency of at least once per week for 3 months, whereas meeting full DSM-IV criteria for BN requires binge eating and purging twice per week for 3 months)
- Major Depression
Exclusion Criteria:
- Diagnosis of bipolar disorder, current psychosis, drug or alcohol abuse in past 3 months, acute suicidal risk, major depression producing significant functional impairment, significant medical illness, weight outside of normal weight range.
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CBT, SP
Arm Description
cognitive behavioral therapy, supportive psychotherapy
Outcomes
Primary Outcome Measures
Binge-eating a purging (EDE scores)
Secondary Outcome Measures
Full Information
NCT ID
NCT00974038
First Posted
September 9, 2009
Last Updated
October 25, 2012
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT00974038
Brief Title
Cognitive Behavior Therapy for Adolescents With Bulimia
Official Title
Cognitive Behavior Therapy for Adolescents With Bulimia Nervosa
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We are interested in studying two different psychological treatments for eating disorders for adolescents (ages 12-18). The study is designed to help adolescents who are having problems with binge eating and/or purging. The treatment consists of 14 sessions of approximately one-hour each over about three months.
Detailed Description
Interested adolescents will have a phone screen and then come in for an in-person psychiatric evaluation. If eligible and interested, they will be randomly assigned to 4 months of outpatient treatment (free of charge) that is either 1) cognitive-behavioral therapy or 2) supportive psychotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa
Keywords
Bulimia Nervosa, EDNOS, Adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT, SP
Arm Type
Experimental
Arm Description
cognitive behavioral therapy, supportive psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
psychotherapy
Intervention Description
1) cognitive-behavioral therapy or 2) supportive psychotherapy
Primary Outcome Measure Information:
Title
Binge-eating a purging (EDE scores)
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current or prior DSM IV diagnosis of Bulimia Nervosa or Sub-threshold Bulimia Nervosa (those who meet all DSM-IV criteria for BN, but engage in subjective binge-eating episodes and binge/purge at a frequency of at least once per week for 3 months, whereas meeting full DSM-IV criteria for BN requires binge eating and purging twice per week for 3 months)
Major Depression
Exclusion Criteria:
Diagnosis of bipolar disorder, current psychosis, drug or alcohol abuse in past 3 months, acute suicidal risk, major depression producing significant functional impairment, significant medical illness, weight outside of normal weight range.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robyn Sysko, Ph.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Study Director
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Links:
URL
http://eatingdisordersclinic.org
Description
Eating Disorders Clinic website
Learn more about this trial
Cognitive Behavior Therapy for Adolescents With Bulimia
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