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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03050632
Other study ID # 4209
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2019
Est. completion date December 2022

Study information

Verified date July 2019
Source Boston University Charles River Campus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2022
Est. primary completion date November 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
N-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).
White 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.

Locations

Country Name City State
United States Boston University Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston University Charles River Campus

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Meal Compliance Therapeutic Food and Snack Log. Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Secondary Mood Mood Monitoring Form Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Secondary Delay Discounting Monetary-Choice Questionnaire Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Secondary Eating Disorder Symptoms Eating Disorder Diagnostic Scale (EDDS) Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Secondary Depression Center for Epidemiologic Studies Depression Scale (CES-D) Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Secondary Depression, Anxiety, and Stress Depression Anxiety Stress Scales (DASS-21) Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
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