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Effects of Cognitive and Emotional Functioning on Treatment Outcomes

An Investigation of the Effects of Cognitive and Emotional Functioning on Treatment Outcomes

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03050632
Acronym
CEO
Enrollment
0
Registered
2017-02-13
Start date
2019-09-30
Completion date
2022-12-31
Last updated
2019-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Disorders

Keywords

working memory, adherence

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.

Interventions

BEHAVIORALN-back

The N-back task is a measure of working memory in which individuals need to make a response to targets which are repeated letters either in a row (i.e., one-back) or in every-other-letter format (i.e., two-back).

BEHAVIORALWhite Bear Task

For this thought suppression task, participants are instructed to inhibit thoughts of a white bear, and to indicate with a pencil mark every time the thought of the white bear occurs to them.

Sponsors

Boston University Charles River Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Meal ComplianceComparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scoresTherapeutic Food and Snack Log.

Secondary

MeasureTime frameDescription
MoodComparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scoresMood Monitoring Form
Delay DiscountingComparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scoresMonetary-Choice Questionnaire
Eating Disorder SymptomsComparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scoresEating Disorder Diagnostic Scale (EDDS)
DepressionComparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scoresCenter for Epidemiologic Studies Depression Scale (CES-D)
Depression, Anxiety, and StressComparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scoresDepression Anxiety Stress Scales (DASS-21)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026