Clinical trial NCT03050632: Effects of Cognitive and Emotional Functioning on Treatment Outcomes
Official title: An Investigation of the Effects of Cognitive and Emotional Functioning on Treatment Outcomes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Eating Disorders
Keywords: working memory
adherence
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2017-02-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Residential patients
* Females 18 and older
* Able to provide informed consent for the study
* Sufficient command of the English language
* Have experience using a computer and mouse
* Diagnosed with an Eating Disorder

Exclusion Criteria:

None

Primary outcomes:
measure: Meal Compliance
timeFrame: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Secondary outcomes:
measure: Mood
timeFrame: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
measure: Delay Discounting
timeFrame: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
measure: Eating Disorder Symptoms
timeFrame: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
measure: Depression
timeFrame: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
measure: Depression, Anxiety, and Stress
timeFrame: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
References: