- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00755391
Cognitive Behavioral Therapy for Adolescents With Bulimia
October 25, 2012 updated by: New York State Psychiatric Institute
This pilot study will evaluate the effectiveness of individual cognitive behavioral therapy (CBT) and supportive psychotherapy (SP) in reducing bulimic symptoms among adolescents.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients will be randomized to have an equal chance of either receiving CBT or SP.
Participants will include both individuals with DSM-IV bulimia nervosa (BN), and patients with sub-threshold BN.
Adolescent patients will be treated at the New York State Psychiatric Institute, with a target recruitment of 20 patients completing the study.
Participants in both conditions will be assessed prior to treatment and at the end of treatment.
This trial is intended to serve as a pilot investigation to determine the feasibility and utility of a larger controlled study in this population.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
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New York, New York, United States, 10032
- New York State Psychiatric Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 12 and 18
- DSM-IV diagnosis of bulimia nervosa or sub-threshold bulimia nervosa (binge eating and/or purging at least once per week)
Exclusion Criteria:
- Diagnosis of bipolar disorder
- Current psychosis
- Drug or alcohol abuse in the past 3 months
- Acute Suicidal Risk
- Major depression producing significant functional impairment
- Significant medical illness
- Weight outside of normal weight range (between 85% and 120% of the 50th percentile for age as measured by standard growth charts)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
---|---|
Placebo Comparator: supportive psychotherapy
supportive psychotherapy: 14 sessions
|
The supportive psychotherapy treatment used in this study will involve identifying issues underlying your child's eating disorder and giving your child information about the psychological processes that tend to maintain or continue eating disorder symptoms.
|
Active Comparator: cognitive behavior therapy
cognitive behavior therapy: 14 sessions
|
The cognitive behavioral therapy used in this study will focus on developing patterns of regular eating, addressing body image issues, and ways to cope with situations that trigger eating disordered behaviors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Eating Disorder Examination scores
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robyn Sysko, PhD, New York State Psychiatric Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
September 18, 2008
First Submitted That Met QC Criteria
September 18, 2008
First Posted (Estimate)
September 19, 2008
Study Record Updates
Last Update Posted (Estimate)
October 26, 2012
Last Update Submitted That Met QC Criteria
October 25, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4819
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.
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