Eating DisordersCEONCT03050632
Effects of Cognitive and Emotional Functioning on Treatment Outcomes
A study testing N-back and White Bear Task in people with Eating Disorders, run by Boston University Charles River Campus at 1 site in United States.
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.). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Eating Disorders
- What is being tested?
- N-back and White Bear Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Eating Disorders
- Being tested
- N-back, White Bear Task
- Keywords
- working memory, adherence
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-backBehavioural
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 TaskBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Working Memory Intervention (N-back) | Experimental | 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). Receives: Behavioral: N-back |
| "White Bear" Task | Placebo comparator | 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. Receives: Behavioral: White Bear Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meal Compliance
Therapeutic Food and Snack Log.
Measured: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Secondary outcomes (5)
Mood
Mood Monitoring Form
Measured: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Delay Discounting
Monetary-Choice Questionnaire
Measured: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Eating Disorder Symptoms
Eating Disorder Diagnostic Scale (EDDS)
Measured: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Depression
Center for Epidemiologic Studies Depression Scale (CES-D)
Measured: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Depression, Anxiety, and Stress
Depression Anxiety Stress Scales (DASS-21)
Measured: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study startSep 2019 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: With change of personnel and lab resources, this study was not feasible without independent funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Otto, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050632
- Sponsor's protocol ID
- 4209
- Acronym
- CEO
- Status last verified
- Jul 2019
- First submitted
- 2 Jan 2017
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Effects of Cognitive and Emotional Functioning on Treatment Outcomes
- ClinicalTrials.gov ID
- NCT03050632
- Acronym / sponsor ID
- CEO / 4209
- Conditions
- Eating Disorders
- Keywords
- working memory, adherence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: With change of personnel and lab resources, this study was not feasible without independent funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Working Memory Intervention (N-back) | Experimental | Behavioral: N-backParticipants 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). |
| "White Bear" Task | Placebo comparator | Behavioral: White Bear TaskParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-backThe 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). | Behavioural | Working Memory Intervention (N-back) |
| White Bear TaskFor 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. | Behavioural | "White Bear" Task |
Primary outcome
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.
5 secondary outcomes
Mood
Time frame: 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
Eating Disorder Symptoms
Time frame: 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
Depression, Anxiety, and Stress
Time frame: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-back and White Bear Task in people with Eating Disorders, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meal Compliance (time frame: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.