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临床试验/NCT03050632
NCT03050632撤回不适用

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

Boston University Charles River Campus1 个研究点 分布在 1 个国家开始时间: 2019年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Meal Compliance

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

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).

干预措施: N-back (Behavioral)

"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.

干预措施: White Bear Task (Behavioral)

结局指标

主要结局

Meal Compliance

时间窗: Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores

Therapeutic Food and Snack Log.

次要结局

  • Mood(Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores)
  • Delay Discounting(Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores)
  • Eating Disorder Symptoms(Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores)
  • Depression(Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores)
  • Depression, Anxiety, and Stress(Comparison of day 5 to day 8 scores taking into account intervention type, intervention order, and baseline scores)

研究者

发起方
Boston University Charles River Campus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Otto

Professor of Psychology

Boston University Charles River Campus

研究点 (1)

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