Viewing Study NCT03050632


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Study NCT ID: NCT03050632
Status: WITHDRAWN
Last Update Posted: 2019-07-10
First Post: 2017-01-02
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Effects of Cognitive and Emotional Functioning on Treatment Outcomes
Sponsor: Boston University Charles River Campus
Organization:

Study Overview

Official Title: An Investigation of the Effects of Cognitive and Emotional Functioning on Treatment Outcomes
Status: WITHDRAWN
Status Verified Date: 2019-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: With change of personnel and lab resources, this study was not feasible without independent funding
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CEO
Brief Summary: The investigators are interested about the degree to which individuals can persist with individualized treatment goals when their cues (external such as food, or internal such as anxiety) are high for impulsive/maladaptive behavior (e.g., purging, not eating, etc.). The investigators want to find specific high-difficulty situations in which to assess whether participants remain mindful of the big picture and are willing to work toward therapeutic goals. Also, the investigators want to rate the participants degree of success (e.g., proportion of calories eaten) assessed more objectively.

The theory is that working memory capacity (WMC) modulates the ability to keep longer-term goals in mind when faced by current stress/temptations. For example, the ability to control drinking when one has an implicit urge to drink is predicted by WMC. The ability to apply a novel emotional regulation skill at a time of stress is also predicted by WMC. Indeed, the generic ability to pursue goals in the future (as assessed by the discounting of the value of future goals) is reliably predicted by WMC. There is also evidence that activation of brain regions associated with WMC (by direct activation of the dorsolateral prefrontal cortex via transcranial magnetic stimulation (TMS), or by having a person complete a relevant cognitive task) improves delay discounting.

Accordingly, the investigators are proposing a study that both assesses the link between WMC and relevant the clinical measures noted above, as well as changes in these measures following activation of WM with a cognitive prime (WM task). The overall design calls for an initial WMC assessment, followed by randomization to complete 3 days of a WM prime and then 3 days of a no prime group, or vice versa. The investigators then assess the clinical outcomes noted above across the following 6 days, with a WM prime first or no prime first occurring prior to the targeted behaviors. The investigators will prime WM prior to participant's evening meal, with the WM intervention offered during the free time before this meal.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: