NCT00071578

Brief Summary

This study will compare two different approaches for the treatment for Binge Eating Disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2003

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

October 1, 2003

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2003

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

June 27, 2013

Status Verified

June 1, 2013

Enrollment Period

3.8 years

First QC Date

October 29, 2003

Last Update Submit

June 26, 2013

Conditions

Eating Disorders

Keywords

PsychotherapyTreatment

Outcome Measures

Primary Outcomes (1)

  • frequency of binge eating

    prior 4 weeks

Secondary Outcomes (1)

  • Emotional Eating Scale

    prior 7 days

Study Arms (2)

1

EXPERIMENTAL

Group therapy Negative Emotion Focus

Behavioral: Group Psychotherapy-Negative Emotion Focus

2

PLACEBO COMPARATOR

Group Psychotherapy- Self Esteem Focus

Behavioral: Group Psychotherapy- Self-Esteem Focus

Interventions

Group Psychotherapy-Negative Emotion FocusBEHAVIORAL

20 weekly sessions, 2 hours, group format

1
Group Psychotherapy- Self-Esteem FocusBEHAVIORAL

20 weekly sessions, 2 hours, group format

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Binge Eating Disorder
  • Reside in the San Francisco Bay Area
  • Willing to commit to the study requirements

You may not qualify if:

  • Unstable medical problems
  • History of bipolar illness or schizophrenia
  • Receiving treatment for an eating disorder (or unwillingness to discontinue treatment upon study entry)
  • Membership in weight-loss groups such as Weight Watchers or Jenny Craig (or unwillingness to discontinue membership upon study entry)
  • Use of medications affecting weight or appetite. Antidepressants are acceptable, but doses of any psychiatric medication must have been stable for at least 3 months prior to study start
  • Breast-feeding
  • Require gastric-bypass surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305-5722, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Debra L Safer, MD

    Stanford University Dept of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst professor

Study Record Dates

First Submitted

October 29, 2003

First Posted

October 30, 2003

Study Start

October 1, 2003

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

June 27, 2013

Record last verified: 2013-06

Locations

US(1)