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临床试验/NCT02906449
NCT02906449Unknown不适用

Investigating the Physiological, Cognitive, and Psychological Effects of a Cognitive-Based Intervention

Brock University0 个研究点目标入组 70 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
70
主要终点
Five Facet Mindfulness Questionnaire

研究概览

简要总结

The primary purpose of this study is to investigate the effectiveness of a brief mindfulness-based intervention for targeting chronic physiological underarousal and post-concussive symptoms following a mild head injury (MHI), as self-reported by undergraduate university students. For the purposes of this study, MHI is defined (and identified) through our demographic questionnaire as a traumatic-based injury to the head - "Have you ever hit your head with a force sufficient to alter your state of consciousness" (consistent with the Kay et al., 1993 criteria/definition; American Congress of Rehabilitation Medicine - ACRM). The investigators exclude congenital or genetic injuries.

详细描述

Seventy subjects, aged 17 to 30 years old, from Brock University will be recruited to participate in the study. The ability to speak and write in English is a requirement. University students will be invited to participate in the study in a series of individual and group testing/training sessions (n ≤ 15) on five separate occasions (two testing sessions and three training sessions). The testing/training sessions will be on average, one week apart (depending on the availability of the participants). Participants will be invited to review the consent form prior to the first testing session via having it e-mailed to them once recruited. At this time, a discussion about the student's potential allergies and sensitivities will take place during the review of 'Potential Risks'. Participants will be given two copies of the written consent form to be completed (one copy is given to the participant and the other copy is for the researcher). Subjects will be advised that alternate arrangements can be made if they prefer 'same sex' researchers. All participants will be administered the same protocol and questionnaire order. These tests are well-researched and their standard administration times will be applied.

During the first session (pre-test), participants will be greeted individually for the session in a lab setting in the Jack and Nora Walker Lifespan Development Centre testing facilities at Brock University. The consent form will be read aloud to the participants by the researcher for clarification, and participants will be invited to ask any questions at that time or any time throughout the study. Participants will then undergo a 3-minute physiological recording and complete two performance-based neuropsychological measures: the Trail Making Test (TMT) to measure cognitive flexibility and the Colour-Word Interference Test to measure attention.

For the physiological measures, subjects will be introduced to the Polygraph Professional (2008) equipment which measures heart rate, electrodermal activity (EDA), respiration and blood pressure. Silver-silver chloride pads will be used to collect EDA, and will be placed on the index and fourth fingers on the participant's non-dominant hand. Electrodermal activation (EDA) responses are measured in terms of amplitude (i.e., the height of the electrodermal response measured in microsiemens [µS]). A pulse oximeter will be placed on the middle finger of the participant's non-dominant hand to measure HR. Respiration will be recorded via two pneumatic chest bands - the upper will be placed around the chest and the lower, around the abdomen and over their clothing. Blood pressure will be measured via a blood pressure cuff that will be placed on the brachial artery/upper portion of the individual's left arm. All core equipment is cleansed with alcohol swabs after use; the researcher will provide the participant with antibacterial lotion prior to application of electrodes; electrodes will be replaced as needed. The sanitary procedures will be explained to the subject and implemented (e.g., experimenter's use of gloves, and use of cleansed and disinfected equipment using alcohol, etc.).

In addition, the participant will be asked to complete a self-report rating of his/her arousal level before physiological activity is recorded (as used in, for example, Baker and Good [2014], participants are shown a scale (from 1 to 10) on a laminated sheet and asked to provide a self-report rating of their current arousal state (1 - e.g., very relaxed to 10 - e.g., very stressed). Subjects will be seated and will be given time to rest prior to, and during, the recordings. Participants will be asked to remain still in a relaxed and comfortable position (to reduce physical movement) while a recording is taken for a 3- minute period. All physiological data recorded will be coded alphanumerically without personal identifiers.

Following the physiological recordings, the Trail Making Test will be administered, during which the subjects are asked to connect a series of numbered and lettered dots according to a specific set of rules. Subsequently, the Colour-Word Interference Test will be administered, during which subjects are asked to read aloud the colour of ink that various colour words are printed in. All neurocognitive tests will be administered under time constraints as dictated by testing protocol. The participant will then be accompanied to a separate (nearby) room to complete a selection of self-report questionnaires in a group testing environment (i.e., with up to 14 other participants). Note: the BDI-II will be scored immediately after the student has completed testing (i.e., immediately after they leave the testing session).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
17 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Students enrolled in University

排除标准

  • Individuals with food allergies associated with chocolate
  • Individuals with skin sensitivities (e.g., with respect to electrode conductive gel)

结局指标

主要结局

Five Facet Mindfulness Questionnaire

时间窗: 5 weeks from the beginning of the study

The FFMQ is a trait measure of mindfulness (end point minus baseline)

Beck Depression Inventory - 2

时间窗: 5 weeks from the beginning of the study

Measures the intensity of depressive symptoms (end point minus baseline)

Beck Anxiety Inventory

时间窗: 5 weeks from the beginning of the study

Measures the intensity of anxiety symptoms (end point minus baseline)

Autonomic Presentation

时间窗: 5 weeks from the beginning of the study

Sympathetic Nervous System measures - EDA, heart rate, blood pressure

Toronto Mindfulness Scale

时间窗: 5 weeks from the beginning of the study

Measure of state mindfulness (end point minus baseline)

次要结局

  • Trail Making Test(5 weeks from the beginning of the study)
  • Color-Word Interference Test(5 weeks from the beginning of the study)
  • Behaviour Rating Inventory of Executive Function - Adult version(5 weeks from the beginning of the study)
  • HEXACO Personality Inventory - Revised(5 weeks from the beginning of the study)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dawn Good

Principal Investigator

Brock University

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