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Cognitive Behavioral Therapy for Adolescents With Bulimia

Primary Purpose

Bulimia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cognitive behavior therapy
Supportive Psychotherapy
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bulimia Nervosa focused on measuring BN and subthreshold BN

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

supportive psychotherapy

cognitive behavior therapy

Arm Description

supportive psychotherapy: 14 sessions

cognitive behavior therapy: 14 sessions

Outcomes

Primary Outcome Measures

Eating Disorder Examination scores

Secondary Outcome Measures

Full Information

First Posted
September 18, 2008
Last Updated
October 25, 2012
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00755391
Brief Title
Cognitive Behavioral Therapy for Adolescents With Bulimia
Official Title
Cognitive Behavioral Therapy for Adolescents With Bulimia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (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
This pilot study will evaluate the effectiveness of individual cognitive behavioral therapy (CBT) and supportive psychotherapy (SP) in reducing bulimic symptoms among adolescents.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa
Keywords
BN and subthreshold BN

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
supportive psychotherapy
Arm Type
Placebo Comparator
Arm Description
supportive psychotherapy: 14 sessions
Arm Title
cognitive behavior therapy
Arm Type
Active Comparator
Arm Description
cognitive behavior therapy: 14 sessions
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavior therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Psychotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eating Disorder Examination scores
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robyn Sysko, PhD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
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

Learn more about this trial

Cognitive Behavioral Therapy for Adolescents With Bulimia

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