Motivating Factors That Play a Role in Bulimia Nervosa

NCT ID: NCT00304174

Last Updated: 2016-05-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2016-05-31

Brief Summary

This study will evaluate whether people with bulimia nervosa will binge eat in a structured laboratory setting and display behavioral patterns similar to those of individuals who are dependent on drugs.

Detailed Description

Bulimia nervosa (BN) is a serious eating disorder that is characterized by frequent uncontrolled eating binges. These binges are often followed by compensatory behavior, including the following: self-induced vomiting; misuse of laxatives, diuretics, enemas, or other medications to induce purging; fasting; or excessive exercise. If left untreated, BN can lead to many serious health issues: tooth decay; irregular menstruation; bowel damage; constipation; heart and kidney disease; intestinal damage; puffiness, especially in the face and fingers; increased hair growth on the face and body; and mineral imbalances in the body. Similar to drug abuse disorders, food-related thinking and disordered eating behavior can interfere with other occupational and social activities, as well. This study will evaluate whether people with bulimia nervosa will binge eat in a structured laboratory setting and display behavioral patterns similar to those of individuals who are dependent on drugs.

Interested participants will first report to the study site for a screening visit, during which they will be assessed for eligibility using blood tests and an interview. Eligible participants will return to the study site on 3 additional days. Participants will be asked to refrain from eating or drinking between 10 P.M. each night before reporting to the study site and 10 A.M. the next day. Each day, participants will receive breakfast, after which they will not be allowed to eat or drink until the end of the day. Participants will then use a computer program to earn food (a yogurt shake) by tapping on the keyboard. More taps on the keyboard will result in a larger amount of food earned by the end of the day. Once experimentation is complete on Day 1, participants will be instructed to eat as much as they can. On Days 2 and 3, participants will be given a small serving of the yogurt shake prior to beginning the computer task. Following the computer task, they will be instructed to either eat until they are comfortable (without restricting or binging), or eat as much as they can. A private bathroom will be available if needed. All participants, including those who did not meet criteria for participation, will be offered treatment at the study clinic once the study is complete.

Conditions

Bulimia Nervosa; Eating Disorders

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects with bulimia nervosa

Participants with bulimia nervosa

Motivation to eat

Intervention Type: BEHAVIORAL

Participants will use a computer program to earn food (a yogurt shake) by tapping on the keyboard. More taps on the keyboard will result in a larger amount of food earned by the end of the day. Once experimentation is complete on Day 1, participants will be instructed to eat as much as they can. On Days 2 and 3, participants will be given a small serving of the yogurt shake prior to beginning the computer task. Following the computer task, they will be instructed to either eat until they are comfortable (without restricting or binging), or eat as much as they can.

Controls between 80-120% of ideal weight

Controls without bulimia nervosa

Motivation to eat

Intervention Type: BEHAVIORAL

Participants will use a computer program to earn food (a yogurt shake) by tapping on the keyboard. More taps on the keyboard will result in a larger amount of food earned by the end of the day. Once experimentation is complete on Day 1, participants will be instructed to eat as much as they can. On Days 2 and 3, participants will be given a small serving of the yogurt shake prior to beginning the computer task. Following the computer task, they will be instructed to either eat until they are comfortable (without restricting or binging), or eat as much as they can.

Interventions

Motivation to eat

Participants will use a computer program to earn food (a yogurt shake) by tapping on the keyboard. More taps on the keyboard will result in a larger amount of food earned by the end of the day. Once experimentation is complete on Day 1, participants will be instructed to eat as much as they can. On Days 2 and 3, participants will be given a small serving of the yogurt shake prior to beginning the computer task. Following the computer task, they will be instructed to either eat until they are comfortable (without restricting or binging), or eat as much as they can.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Participants with Bulimia Nervosa:

• Meets DSM-IV criteria for bulimia nervosa
• Duration of illness is greater than 1 year
• Self-induces vomiting
• Weighs between 80% and 120% of ideal weight
• Female

Control Group:

• Weighs between 80% and 120% of ideal weight
• Female
• Ages 18-45
• No current or past psychiatric illness
• No history of eating disorder

Exclusion Criteria

Participants with Bulimia Nervosa:

• Significant medical illness
• Current Axis I illness other than major depression
• Severe or very severe depression
• At risk for suicide
• Currently taking medication
• History of drug or alcohol abuse within the 6 months prior to study entry
• Pregnant
• Male

Control Group:

• Significant medical illness
• Currently taking medication
• History of drug or alcohol abuse within the 6 months prior to study entry
• Pregnant
• Male
• History of any eating disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

B. T. Walsh, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute at Columbia University Medical Center

Locations

Eating Disorders Clinic, New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Other Identifiers

R21MH065024-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DNBBS 72-NBR

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

#5049/#6178R

Identifier Type: -

Identifier Source: org_study_id