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

July 8, 2019 updated by: Michael Otto, Boston University Charles River Campus

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Boston University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Working Memory Intervention (N-back)
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).
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).
Placebo Comparator: "White Bear" Task
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Meal Compliance
Time Frame: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Therapeutic Food and Snack Log.
Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood
Time Frame: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Mood Monitoring Form
Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Delay Discounting
Time Frame: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Monetary-Choice Questionnaire
Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Eating Disorder Symptoms
Time Frame: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Eating Disorder Diagnostic Scale (EDDS)
Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Depression
Time Frame: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
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
Depression, Anxiety, and Stress
Time Frame: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Depression Anxiety Stress Scales (DASS-21)
Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University Charles River Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 2, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (Actual)

February 13, 2017

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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