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

• ClinicalTrials.gov Identifier: NCT03050632
• Recruitment Status: Withdrawn
• First Posted: February 13, 2017
• Last Update Posted: July 10, 2019
• Sponsor: Boston University Charles River Campus
• Information provided by (Responsible Party): Michael Otto, Boston University Charles River Campus

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.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 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: September 2019
• Estimated Primary Completion Date: November 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

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.

Outcome Measures

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)

Eligibility Criteria

• 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:

None

Contacts and Locations

Locations

United States, Massachusetts

Boston University

Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Boston University Charles River Campus

More Information

• Responsible Party: Michael Otto, Professor of Psychology, Boston University Charles River Campus
• ClinicalTrials.gov Identifier: NCT03050632
• Other Study ID Numbers: 4209
• First Posted: February 13, 2017
• Last Update Posted: July 10, 2019
• Last Verified: July 2019

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