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Cognitive Behavioral Therapy for Adolescents With Bulimia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00755391
First Posted: September 19, 2008
Last Update Posted: October 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
New York State Psychiatric Institute
  Purpose
This pilot study will evaluate the effectiveness of individual cognitive behavioral therapy (CBT) and supportive psychotherapy (SP) in reducing bulimic symptoms among adolescents.

Condition Intervention
Bulimia Nervosa Behavioral: cognitive behavior therapy Behavioral: Supportive Psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for Adolescents With Bulimia

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Eating Disorder Examination scores [ Time Frame: 28 days ]

Enrollment: 8
Study Start Date: February 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: supportive psychotherapy
supportive psychotherapy: 14 sessions
Behavioral: Supportive Psychotherapy
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
Behavioral: cognitive behavior therapy
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 12 and 18
  2. DSM-IV diagnosis of bulimia nervosa or sub-threshold bulimia nervosa (binge eating and/or purging at least once per week)

Exclusion Criteria:

  1. Diagnosis of bipolar disorder
  2. Current psychosis
  3. Drug or alcohol abuse in the past 3 months
  4. Acute Suicidal Risk
  5. Major depression producing significant functional impairment
  6. Significant medical illness
  7. Weight outside of normal weight range (between 85% and 120% of the 50th percentile for age as measured by standard growth charts)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755391


Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Robyn Sysko, PhD New York State Psychiatric Institute
  More Information

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00755391     History of Changes
Other Study ID Numbers: 4819
First Submitted: September 18, 2008
First Posted: September 19, 2008
Last Update Posted: October 26, 2012
Last Verified: October 2012

Keywords provided by New York State Psychiatric Institute:
BN and subthreshold BN

Additional relevant MeSH terms:
Bulimia
Bulimia Nervosa
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders