Effects of Cognitive and Emotional Functioning on Treatment Outcomes

Eating Disorders Clinical Trial

— CEO  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03050632
• Other study ID #: 4209
• Status: Withdrawn
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Eating Disorders
• Feeding and Eating Disorders

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