Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT02906449 |
| Other study ID # |
DGBrockU |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
September 15, 2016 |
| Last updated |
September 19, 2016 |
| Start date |
October 2016 |
| Est. completion date |
August 2017 |
Study information
| Verified date |
September 2016 |
| Source |
Brock University |
| Contact |
Dawn E Good, PhD, CPsych |
| Phone |
905-688-5550 |
| Email |
dawn.good[@]brocku.ca |
| Is FDA regulated |
No |
| Health authority |
Canada: Ethics Review Committee |
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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).
During this group testing session, participants will be asked to complete a selection of
untimed, self-paced self-report questionnaires that measure the following: psychopathology -
e.g., depressive and anxiety symptoms (Beck Depression Inventory [BDI], Beck Anxiety
Inventory [BAI]); executive functioning (Behavior Rating Inventory of Executive Function -
Adult [BRIEF-A]); trait mindfulness (Five Facet Mindfulness Questionnaire [FFMQ]),
personality characteristics (HEXACO Personality Inventory - Revised [HEXACO-PI-R]) and
lastly demographics (Everyday Living Questionnaire), which includes a measure of
post-concussive symptoms (Post-Concussion Symptom Scale [PCS]). The first session is
expected to take approximately 1.5 hours to complete in total.
Following the completion of the first testing session, participants will be instructed to
sign-up for a cognitive training session, which will take place within one week following
the pre-test session. Participants will be randomly assigned to either a mindfulness
training session (experimental group; n = 35) or a relaxation training session (control
group; n = 35).
Both the mindfulness training group and the relaxation training group will meet for
approximately 30 minutes each week, across three separate training sessions. Participants
will be greeted as a group for the session in a lab setting in the Jack and Nora Walker
Lifespan Development Centre testing facilities at Brock University. Participants in the
mindfulness training group will partake in an interactive training session, which will
involve learning core mindfulness-related concepts, as well as engaging in progressively
advanced mindfulness exercises. Note: For exercises involving the consumption of food
products, participants will be notified in advance (and immediately before the exercises) of
the food products that will be involved in the exercise. Participants will be cautioned to
take into consideration any food allergies and/or dietary restrictions they may have -
precautions will be taken such that the risk of food allergies is minimized (e.g., selecting
foods that are nut-free). Following the formal mindfulness sessions, participants will be
instructed to complete daily "homework" exercises (for approximately 5 minutes per day),
which will be accessible as handouts and audio recordings on a Brock University Sakai site.
Participants will be asked to complete an online questionnaire (taking approximately one
minute to complete) each day to record details regarding their daily mindfulness practice.
The procedure for the relaxation training sessions will be similar to the mindfulness
sessions. Participants in the relaxation training group will partake in an interactive
training session, which will involve learning about the link between stress and cognition,
as well as engaging in progressively advanced relaxation techniques focused on reducing
anxiety or stress prior to cognitively-demanding tasks. Following the formal relaxation
sessions, participants will be instructed to complete daily "homework" exercises (for
approximately 5 minutes per day), which will be accessible as handouts and audio recordings
on a Brock University Sakai site. Participants will be asked to complete an online
questionnaire (taking approximately one minute to complete) each day to record details
regarding their daily relaxation practice.
At the end of every training session (for the mindfulness group and control group),
participants will be asked to complete a short self-report questionnaire, measuring state
mindfulness (i.e., the Toronto Mindfulness Scale [TMS]).
During the final session (post-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 post-test session will follow the same procedure as the
pre-test session (as described earlier). Participants will complete the same physiological,
neuropsychological, and self-report measures as described in the pre-test session, with two
exceptions: (1) a shorter version of the Everyday Living Questionnaire (and attached
Post-Concussion Symptom Scale) will be used to assess changes in post-concussive symptoms
since the first testing session. As well, athletic, educational, familial, and pre-test
medical history information will not be reassessed. The post-test session will take
approximately 1.5 hours to complete.
Upon completion of the study (at the end of the post-test session), participants will be
debriefed as to the nature and purpose of the study, and thanked for their participation.
Overall, participation in the study will not exceed 6 hours. Included in the debriefing form
is counselling contact information for Brock University Counselling Services should any
negative emotions surface as a result of participation in the study. Participants will also
receive contact information for the principal investigator/faculty supervisor, principal and
co-student investigators. Finally, participants will be thanked for their time and
participation, and will be invited to review the results of the study at its completion (by
August 2017).
