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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00755391
Other study ID # 4819
Secondary ID
Status Completed
Phase N/A
First received September 18, 2008
Last updated October 25, 2012
Start date February 2008
Est. completion date February 2010

Study information

Verified date October 2012
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This pilot study will evaluate the effectiveness of individual cognitive behavioral therapy (CBT) and supportive psychotherapy (SP) in reducing bulimic symptoms among adolescents.


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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 18 Years
Eligibility 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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Eating Disorder Examination scores 28 days No
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