NCT00974038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

October 26, 2012

Status Verified

October 1, 2012

Enrollment Period

3.3 years

First QC Date

September 9, 2009

Last Update Submit

October 25, 2012

Conditions

Bulimia Nervosa

Keywords

Bulimia Nervosa, EDNOS, Adolescents

Outcome Measures

Primary Outcomes (1)

  • Binge-eating a purging (EDE scores)

    1 year

Study Arms (1)

CBT, SP

EXPERIMENTAL

cognitive behavioral therapy, supportive psychotherapy

Behavioral: psychotherapy

Interventions

psychotherapyBEHAVIORAL

1\) cognitive-behavioral therapy or 2) supportive psychotherapy

CBT, SP

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Links

MeSH Terms

Conditions

Bulimia Nervosa

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Robyn Sysko, Ph.D.

    New York State Psychiatric Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2009

First Posted

September 10, 2009

Study Start

November 1, 2006

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

October 26, 2012

Record last verified: 2012-10

Locations

US(1)