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Effects of Cognitive and Emotional Functioning on Treatment Outcomes (CEO)

Primary Purpose

Eating Disorders

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
N-back
White Bear Task
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring working memory, adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Boston University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Working Memory Intervention (N-back)

"White Bear" Task

Arm Description

Participants will complete the working memory priming task either for the first 3 days of the intervention or the last 3 days of the intervention, with order counterbalanced across participants. The working memory prime is the N-back test, 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) (Jaeggi et al., 2010).

Participants will complete this non-working-memory control task either for the first 3 days of the intervention or the last 3 days of the intervention, depending on counterbalanced order. The task consists of a procedure developed by Wegner and colleagues (1987) in a study of thought suppression, which instructs participants 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.

Outcomes

Primary Outcome Measures

Meal Compliance
Therapeutic Food and Snack Log.

Secondary Outcome Measures

Mood
Mood Monitoring Form
Delay Discounting
Monetary-Choice Questionnaire
Eating Disorder Symptoms
Eating Disorder Diagnostic Scale (EDDS)
Depression
Center for Epidemiologic Studies Depression Scale (CES-D)
Depression, Anxiety, and Stress
Depression Anxiety Stress Scales (DASS-21)

Full Information

First Posted
January 2, 2017
Last Updated
July 8, 2019
Sponsor
Boston University Charles River Campus
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1. Study Identification

Unique Protocol Identification Number
NCT03050632
Brief Title
Effects of Cognitive and Emotional Functioning on Treatment Outcomes
Acronym
CEO
Official Title
An Investigation of the Effects of Cognitive and Emotional Functioning on Treatment Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Why Stopped
With change of personnel and lab resources, this study was not feasible without independent funding
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University Charles River Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders
Keywords
working memory, adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Working Memory Intervention (N-back)
Arm Type
Experimental
Arm Description
Participants will complete the working memory priming task either for the first 3 days of the intervention or the last 3 days of the intervention, with order counterbalanced across participants. The working memory prime is the N-back test, 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) (Jaeggi et al., 2010).
Arm Title
"White Bear" Task
Arm Type
Placebo Comparator
Arm Description
Participants will complete this non-working-memory control task either for the first 3 days of the intervention or the last 3 days of the intervention, depending on counterbalanced order. The task consists of a procedure developed by Wegner and colleagues (1987) in a study of thought suppression, which instructs participants 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.
Intervention Type
Behavioral
Intervention Name(s)
N-back
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
White Bear Task
Intervention Description
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.
Primary Outcome Measure Information:
Title
Meal Compliance
Description
Therapeutic Food and Snack Log.
Time Frame
Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Secondary Outcome Measure Information:
Title
Mood
Description
Mood Monitoring Form
Time Frame
Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Title
Delay Discounting
Description
Monetary-Choice Questionnaire
Time Frame
Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Title
Eating Disorder Symptoms
Description
Eating Disorder Diagnostic Scale (EDDS)
Time Frame
Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Title
Depression
Description
Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame
Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Title
Depression, Anxiety, and Stress
Description
Depression Anxiety Stress Scales (DASS-21)
Time Frame
Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Cognitive and Emotional Functioning on Treatment Outcomes

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