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Trial record 30 of 126 for:    Recruiting, Not yet recruiting, Available Studies | "Eating Disorders"

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

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ClinicalTrials.gov Identifier: NCT03050632
Recruitment Status : Not yet recruiting
First Posted : February 13, 2017
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Michael Otto, Boston University Charles River Campus

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.


Condition or disease Intervention/treatment Phase
Eating Disorders Behavioral: N-back Behavioral: White Bear Task Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Investigation of the Effects of Cognitive and Emotional Functioning on Treatment Outcomes
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Mood [ Time Frame: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores ]
    Mood Monitoring Form

  2. 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

  3. 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)

  4. 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)

  5. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050632


Contacts
Contact: Michael W Otto, PhD 617-353-9610 mwotto@bu.edu
Contact: Ani C Keshishian, B.A. 617-504-4522 akeshish@bu.edu

Locations
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston University Charles River Campus

Responsible Party: Michael Otto, Professor of Psychology, Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT03050632     History of Changes
Other Study ID Numbers: 4209
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Otto, Boston University Charles River Campus:
working memory
adherence

Additional relevant MeSH terms:
Feeding and Eating Disorders
Mental Disorders