Understanding The Effects of Acute Stressors and Negative Emotion on Eating Behavior in Binge-Eating Disorder: The Role of Stressor-Induced Changes in Reward and Cognitive Control
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mclean Hospital
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Decision-making behavior (actual decisions)
Study Overview
Brief Summary
The investigators are doing a study of women with and without binge-eating disorder to learn more about what happens when people engage in everyday decision-making activities. The investigators are interested in learning more about brain activity during everyday decision-making and how everyday decision-making relates to a variety of daily experiences. Examples of everyday decisions include deciding which product to buy, deciding what to eat for a snack, and deciding how to spend free time.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Inclusion Criteria for All Participants:
- •Normal or corrected to normal vision and hearing
- •Verbal and written fluency in English
- •Right-handed
- •Body mass index of 20-35 kg/m^2
- •Additional Inclusion Criteria for Participants with Binge-Eating Disorder:
- •DSM-5 binge-eating disorder
Exclusion Criteria
- •Exclusion Criteria for All Participants:
- •Impaired cognition or other neurological/cognitive problems
- •Contraindications to MRI (e.g., certain metal implants, claustrophobia)
- •Currently/recently/potentially pregnant, seeking to become pregnant in the near future, or breastfeeding
- •Serious and/or unstable medical diseases and conditions, and certain other medical diseases and conditions
- •Recent low weight
- •Certain medications (e.g., insulin)
- •Current/recent frequent recreational drug use, or history of frequent recreational drug use in early adolescence
- •Extreme dietary limitations (e.g., veganism), pervasive food allergies, or limited exposure to popular snack foods
- •Current/recent suicidality
- •Current/recent changes in treatment for mental illness
- •Study-relevant research experience
- •Additional Exclusion Criteria for Comparison Participants:
- •Personal history of eating disorders or recurrent binge eating
- •Personal history of any other mental illness, including serious substance use problems
- •First-degree relative with current or past eating or psychotic disorder
- •Significant recent change in weight
- •Additional Exclusion Criteria for Participants with Binge-Eating Disorder:
- •Severe mental illness (e.g., psychotic disorder, severe agoraphobia)
- •Certain other current/recent mental illness, including severe substance use problems, that would limit study participation or safety
- •Recent anorexia nervosa spectrum disorder, avoidant-restrictive food intake disorder, or bulimia nervosa spectrum disorder
Arms & Interventions
Speaking Activity and Talking Activity
Participants will engage in a speaking activity first and a talking activity second.
Intervention: Talking Activity (Behavioral)
Speaking Activity and Talking Activity
Participants will engage in a speaking activity first and a talking activity second.
Intervention: Speaking Activity (Behavioral)
Talking Activity and Speaking Activity
Participants will engage in a talking activity first and a speaking activity second.
Intervention: Speaking Activity (Behavioral)
Talking Activity and Speaking Activity
Participants will engage in a talking activity first and a speaking activity second.
Intervention: Talking Activity (Behavioral)
Outcomes
Primary Outcomes
Decision-making behavior (actual decisions)
Time Frame: Up to 1 hour post-intervention
Decisions (i.e., percent of goal-inconsistent decisions from challenge trials)
Decision-related BOLD activation (reward regions-of-interest)
Time Frame: Up to 1 hour post-intervention
Percent change in blood oxygen level-dependent (BOLD) signal in response to decision making in regions involved in reward (e.g., nucleus accumbens, insula)
Decision-related BOLD activation (executive function regions-of-interest)
Time Frame: Up to 1 hour post-intervention
Percent change in blood oxygen level-dependent (BOLD) signal in response to decision making in regions involved in executive function (e.g., dorsolateral prefrontal cortex, inferior frontal gyrus)
Secondary Outcomes
No secondary outcomes reported
Investigators
Kristin Nicole Javaras
Assistant Psychologist, Division of Women's Mental Health, McLean Hospital; Assistant Professor of Psychology, Department of Psychiatry, Harvard Medical School
Mclean Hospital