NCT00755391

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.

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 Feb 2008

Typical duration 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

February 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2008

Completed
1.4 years 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

2 years

First QC Date

September 18, 2008

Last Update Submit

October 25, 2012

Conditions

Keywords

BN and subthreshold BN

Outcome Measures

Primary Outcomes (1)

  • Eating Disorder Examination scores

    28 days

Study Arms (2)

supportive psychotherapy

PLACEBO COMPARATOR

supportive psychotherapy: 14 sessions

Behavioral: Supportive Psychotherapy

cognitive behavior therapy

ACTIVE COMPARATOR

cognitive behavior therapy: 14 sessions

Behavioral: cognitive behavior therapy

Interventions

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.

cognitive behavior therapy

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.

supportive psychotherapy

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

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

MeSH Terms

Conditions

Bulimia Nervosa

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Robyn Sysko, PhD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2008

First Posted

September 19, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

October 26, 2012

Record last verified: 2012-10

Locations