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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:

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.

Current Primary Outcome: Functional near-infrared spectroscopy [ Time Frame: Day 1 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Body mass index [ Time Frame: Day 1 and 1 year ]
  Body mass index, calculated from height and weight measurements
• Eating disorder examination (EDE) [ Time Frame: Day 1 and 1 Year ]
  Used to assess eating disorder symptom frequency and severity, including binge eating episode frequency.
• Wechsler Abbreviated Scale of Intelligence (WASI™) [ Time Frame: Day 1 ]
• Mini-International Neuropsychiatric Interview (MINI) [ Time Frame: Day 1 ]
• Button pressing go/no-go task [ Time Frame: Day 1 ]
• Go/no-go sipping task [ Time Frame: Day 1 ]
• Psychosocial self-report measures [ Time Frame: Day 1 and 1 Year ]
  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
• Positive and Negative Affect Schedule (PANAS) [ Time Frame: Day 1 ]
  This measure will assess mood ratings before the participant completes the standard go/no-go task and the sipping go/no-go task
• Generalized Labeled Magnitude Scale (gLMS) [ Time Frame: Day 1 ]

Original Secondary Outcome: Same as current

Information By: Drexel University

Dates:
Date Received: August 5, 2013
Date Started: June 2011
Date Completion:
Last Updated: October 6, 2014
Last Verified: October 2014