Self-regulatory Control and Eating: A Neuroimaging Study of Bulimia Nervosa

The purpose of this study will be to replicate previous findings of deficits in prefrontal activation during response inhibition tasks in bulimia nervosa and extend these findings by demonstrating similar deficiencies in activity during a functional behavioral task that requires the inhibition of eating. Findings from this study will potentially help to elucidate the underlying neural mechanisms of bulimia nervosa, and thus inform treatment and prevention efforts.

Study Overview

• Status: Completed
• Conditions: Bulimia Nervosa

Detailed Description

Bulimia nervosa (BN), is a serious psychiatric disorder that has high rates of comorbidity and often results in role impairment for the suffer. Thus far, although psychosocial and behavioral risk factors and correlates of BN have been extensively researched, relatively few studies have focused on brain-based determinants of BN. Identification of neural mechanisms associated with self-regulatory control that may be integral in the development, maintenance, and prevention of this debilitating condition would better inform treatment development and eating disorder prevention efforts.

Participation in this study consists of a 3-3.5 hours study visit as well a a one year follow up visit. The first portion of initial study visit is part of the screening process, in which individuals will complete several questionnaires and be interviewed by the study researcher in order to confirm eligibility. If a participant is eligible after the screening portion, they move onto the rest of the initial visit. During the initial visit, participants will complete a button pressing go/no-go task as well as a sipping go/no-go task, all while wearing a functional near-infrared spectroscopy (fNIR) device.

At a one year follow up appointment, individuals will again complete a variety of self-report questionnaires and be interviewed by the study researcher, thus completing the same measures used as screening tools in the initial visit.

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women (ages 18-45 years) with bulimia nervosa and age, BMI, and IQ-matched controls.

Description

Inclusion Criteria:

• Female
• Right-handed
• Age 18-45
• Between 85 and 120% of ideal body weight based on height
• Currently meeting proposed DSM-5 criteria for Bulimia Nervosa (at least one objective bulimic episode and compensatory purging episode per week for the past three months)
• Purging via self-induced vomiting
• Duration of illness of at least 6 months

Exclusion Criteria:

• Current significant medical illness
• Any disorder or condition resulting in difficulty swallowing (e.g., dysphagia)
• History of neurological disorders or diseases (e.g., stroke, seizures, heart disease, head trauma with loss of consciousness)
• Drug or alcohol abuse in the past 6 months or any history of alcohol or drug dependence
• Use of marijuana or any other illegal drug (e.g., cocaine, heroin, ecstasy) in the week before the study visit
• IQ less than 75
• Pregnancy, lactation, or planning to become pregnant in the next year
• Allergy to sucrose, dairy, wheat, gluten, apples (i.e., any of the ingredients in the strawberry yogurt shake or in the standardized meal prior to study participation)
• Participants rating the strawberry yogurt shake as a 5 or lower on a 9-point category scale of liking will be excluded from further study
• Meeting the criteria for a diagnosis of Attention Deficit Hyperactivity Disorder
• Any other current major Axis I disorder, other than major depressive disorder (MDD) or generalized anxiety disorder (GAD)
• Inability to consent
• Prisoner

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Women with Bulimia Nervosa; fNIR - Functional near-infrared spectroscopy measured-brain activity
Healthy Controls; fNIR - Functional near-infrared spectroscopy measured-brain activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functional near-infrared spectroscopy	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	Body mass index, calculated from height and weight measurements	Day 1 and 1 year
Eating disorder examination (EDE)	Used to assess eating disorder symptom frequency and severity, including binge eating episode frequency.	Day 1 and 1 Year
Wechsler Abbreviated Scale of Intelligence (WASI™)		Day 1
Mini-International Neuropsychiatric Interview (MINI)		Day 1
Button pressing go/no-go task		Day 1
Go/no-go sipping task		Day 1
Psychosocial self-report measures	Measures to be administered include: Power of Food Scale (PFS), Beck Anxiety Inventory (BAI), Center for Epidemiological Studies Depression Scale (CES-D), Barratt Impulsivity Scale, Version 11 (BIS), Eating Loss of Control Scale (ELOCS), Difficulties in Emotion Regulation Scale (DERS), and Behavioral Inhibition and Behavioral Activation (BIS/BAS) Scales	Day 1 and 1 Year
Positive and Negative Affect Schedule (PANAS)	This measure will assess mood ratings before the participant completes the standard go/no-go task and the sipping go/no-go task	Day 1
Generalized Labeled Magnitude Scale (gLMS)		Day 1

Collaborators and Investigators

• Sponsor: Michael Lowe

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: August 5, 2013
• First Submitted That Met QC Criteria: August 30, 2013
• First Posted (ESTIMATE): September 5, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 7, 2014
• Last Update Submitted That Met QC Criteria: October 6, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Neuroimaging; Bulimia Nervosa; Bulimia; Response Inhibition; fNIR
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Hyperphagia; Bulimia; Bulimia Nervosa
• Other Study ID Numbers: 1F31MH097406 (NIH)