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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00071578
Other study ID # K23MH066330
Secondary ID K23MH066330DSIR
Status Completed
Phase N/A
First received October 29, 2003
Last updated June 26, 2013
Start date October 2003
Est. completion date July 2007

Study information

Verified date June 2013
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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


Description:

Binge Eating Disorder (BED) is associated with impairments in physical, psychological, and social functioning. Research has revealed relationships between disordered eating and both low self-esteem and negative emotional states.

Participants in this study will complete assessment interviews regarding their eating disorder and associated problems. Similar assessments will be conducted at the end of the study. Participants will then be randomly assigned to one of two therapy groups. Participants in one group will focus on the role of self-esteem, self-awareness, and personal effectiveness in binge eating. Participants in the other group will focus on the role of negative emotions and binge eating. Both treatments will involve a 30 to 40 minute pre-treatment individual orientation session, followed by 20 weeks of weekly group therapy. Sessions will take place over 22 weeks, or approximately 6 months (18 weekly sessions followed by 2 biweekly sessions). Follow-up assessments will take place at 3 months, 6 months, and 12 months after study completion to assess maintenance of treatment effects.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of Binge Eating Disorder

- Reside in the San Francisco Bay Area

- Willing to commit to the study requirements

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Group Psychotherapy-Negative Emotion Focus
20 weekly sessions, 2 hours, group format
Group Psychotherapy- Self-Esteem Focus
20 weekly sessions, 2 hours, group format

Locations

Country Name City State
United States Stanford University Medical Center Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary frequency of binge eating prior 4 weeks No
Secondary Emotional Eating Scale prior 7 days No
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