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Ethics proposal
Additional documents
-
Study Adverts
Participant information sheet
Consent Form
Debriefing statement
Questionnaire booklet
VPT protocol
VPT verbal instructions for participants
Version 1. 25/04/10
Participant Information Sheet
(Version no. 1, 25/4/10)
Study Title:
Cognitive and emotional risk factors for developing postconcussional
syndrome: A prospective investigation of outcome following mild traumatic brain
injury (MTBI).
Researcher: Nicola Rist
Study number: XXXX
Ethics number: ID1174
Version number: 1
Please read this information carefully before deciding to take part in this
research. If you are happy to participate you will be asked to sign a consent
form.
Thank you for volunteering to take part in this study. The information provided on this
sheet is for your information and for you to keep.
Who is conducting the research?
I am Nicola Rist and I am a student on the MSc Health Psychology programme. I am
conducting research as part of a wider on-going research project which is being
conducted by researchers from the Schools of Medicine and Psychology, University
of Southampton, and Southampton General Hospital.
What is the purpose of the study?
Mild traumatic brain injury (MTBI) is a common event. Most people who have MTBI
recover quickly. However around 20-30% experience ongoing symptoms and
develop a condition known as a post concussional syndrome (PCS), which is a
chronic and disabling condition. The purpose of this study is to try and find out who
might be at risk of developing PCS and who recovers quickly. This study will also
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help us to develop further intervention programmes to prevent the development of
PCS.
I have not suffered a MTBI, so why is my contribution important?
Recruiting ‘healthy control’ participants is a vital part of the research, to provide a
comparison between the data collected from participants who have suffered a MTBI
and people like yourself who have not.
What will happen to me if I take part?
If you decide to take part you will be asked to complete a 10 minute computer task
followed by a questionnaire booklet, which should take about 10-15 minutes to fill
out. The computer task will involve you briefly seeing a series of paired pictures and
words and responding to them by pressing buttons on the keyboard. The
questionnaire booklet will ask you about your experience of anxiety and depression
related symptoms and about how respond to things like “changes in your heart-rate”.
All of the questions require a ‘tick-box’ type response. The questionnaire booklet will
also include questions related to your age, gender, education, occupation/income,
marital status, and ethnicity.
Are there any benefits in my taking part?
Although you will not benefit yourself directly by taking part, your data will be useful
for helping us understand who might be at risk of developing PCS. This study will
potentially aid the development of intervention programmes to prevent the people
suffering from PCS.
Are there any risks involved?
The content of tasks may cause very mild psychological arousal (i.e. you might feel a
little uncomfortable being asked about how you’ve been feeling lately), but this
should be no more risky than joining in conversations which happen in everyday life.
Will my participation be confidential?
The information you provide will be kept safe and confidential, in compliance with the
Data Protection Act and University policy. The information you provide will only be
available to the research team.
What happens if I change my mind?
You have the right to withdraw from the study at any time without your legal rights
being affected.
What happens if something goes wrong?
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In the very unlikely event that you have any concerns or complaints with regards to
this study you can contact the Chair of the Ethics Committee, Department of
Psychology, University of Southampton, Southampton, SO17 1BJ. Phone: (023)
8059 5578.
Where can I get more information?
You can contact the researcher, Nicola Rist: naf@soton.ac.uk or the research
supervisor, Prof. Rona Moss-Morris: remm@soton.ac.uk.
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Participant Identification Number:
CONSENT FORM
Title of Project: Cognitive and emotional risk factors for developing postconcussional
syndrome: A prospective investigation of outcome following mild traumatic brain
injury.
(Ref:)
Name of Researcher: Nicola Rist, MSc Health Psychology
Name of Supervisor: Professor Rona Moss-Morris, Professor of Health Psychology,
Please initial boxes
1. I confirm that I have read and understand the information sheet dated 25/04/2010
(Version 1) for the above study. I have had the opportunity to consider the information,
ask questions and have had these answered satisfactorily.
2. I understand that my participation is voluntary and that I am free to withdraw at any
time without giving any reason and that there will be no adverse consequence for myself as
a result.
4. I can confirm that I have not suffered from a head injury at any point in the last 5 years
and that I am not currently suffering from chronic pain symptoms, any other neurological
disorder or significant health condition.
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_______________
________________
_________________
Name of Participant
_________________
Date
Signature
________________
__________________
Name of Person
taking consent
Date
When completed, 1 for participant; 1 for researcher site file.
Signature
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[Cognitive and emotional risk factors for developing postconcussional
syndrome: A prospective investigation of outcome following mild traumatic
brain injury.]
Verbal Script for Research Participants
I am Nicola Rist an Msc Health Psychology student at the University of
Southampton. I am requesting your participation in a study regarding risk factors for
developing postconcussional syndrome. You have been recruited as a ‘healthy
control participant’. This will involve completing a computer-based task (which should
take 10-15 minutes) and a short questionnaire booklet (which should take 15-20
minutes to complete). I will give you full instructions for how to complete the
computer-task and the questionnaires.
Personal information will not be released to or viewed by anyone other than
researchers involved in this project. Results of this study will not include your name
or any other identifying characteristics.
Your continued participation in this research will be taken as evidence of your
giving informed consent to participate in this study and for your data to be used for
the purposes of research, and that you understand that published results of this
research project will maintain your confidentiality. Your participation is voluntary and
you may withdraw your participation at any time. If you have any questions please
ask them now.
If you have questions about your rights as a participant in this research, or if you feel
that you have been placed at risk, you may contact the Chair of the Ethics
Committee, Department of Psychology, University of Southampton, Southampton,
SO17 1BJ. Phone: (023) 8059 5578.
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Cognitive and emotional risk factors for developing postconcussional syndrome: A
prospective investigation of outcome following lid traumatic brain injury.
Written Debriefing Statement
The aim of this study was to gain insight into the cognitive and emotional factors which
may contribute to the development of post-concussional syndrome (PCS). It is expected
that results from this study will contribute to the information gained by researchers as part
of a wider research project, and ultimately guide the development of interventions
designed to reduce the possibility of people developing PCS. Once again, results of this
study will not include your name or any other identifying characteristics. If you would like to
be informed of the findings of my MSc research project, please provide me with your email
address and I will send you the results around August 2010.
If you have any further questions please contact me, Nicola Rist, at naf306@soton.ac.uk.
Thank you for your participation.
Signature ______________________________
Date __________________
Name:_____________________________________________________________
If anything which you have seen or experienced whilst taking part in this research has
upset you please make it known to the researcher (contact details above) or make contact
with:
The University of Southampton Counselling Services - Tel: +44 (0)23 8059 3719 (internal
23719) Email: counser@soton.ac.uk
Or The Samaritans, who offer a confidential helpline – Tel: 08457 909090 Email:
jo@samaritans.org
If you have questions about your rights as a participant in this research, or if you feel that
you have been placed at risk, you may contact the Chair of the Ethics Committee,
Department of Psychology, University of Southampton, Southampton, SO17 1BJ.
Phone: (023) 8059 5578.
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(Ref:)
Cognitive and emotional risk factors for developing postconcussional
syndrome: A prospective investigation of outcome following mild traumatic brain
injury (MTBI).
Questionnaire Booklet
(TO BE COMPLETED BY RESEARCH PARTICIPANTS)
Thank you for agreeing to participate in this study.
There are no right or wrong answers to these questions. We are most interested in your
own personal views rather than those of your family.
 We ask you to answer the questions as honestly and as quickly as
possible.
 As there are a lot of questions to answer in this booklet, please take a
short break if you find it hard to keep your mind on the statements.
This questionnaire booklet is completely
CONFIDENTIAL.
It will only be seen by the researchers involved in the study.
Thank you very much for your time
PARTICIPANT ID _________________
DATE(dd/mm/yy) _________________
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Sociodemographic Questionnaire
1. Are you?
Male
2. How old are you?
Female
_______ years
3. Date of birth ________ (dd)/________(mm)/__________(yyyy)
4. Please tick the appropriate box which best describes your ethnic origin.
a) Black or Black British
Caribbean
African
Any other Black background
b) White
British
Irish
Any other White background
c) Asian or Asian British
Indian
Pakistani
Bangladeshi
Any other Asian background
d) Mixed
White & Black Caribbean
White & Black African
White & Asian
Any other mixed background
e) Other ethnic groups
Chinese
Any other ethnic group
Not stated
5. What is your marital status? (see over)
Single
Married
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Living with a partner
Separated
Divorced
Widowed
6. Who do you live with?
Husband/wife/steady partner
Spouse/partner and children
Parents
Alone
Other
7. Do you have any dependants? (Please state the number)
Children under 5
________
Children over 5
________
Elderly relative
________
Other
________
8. Usual place of residence:
Owner occupied flat or house
Privately rented flat or house
Flat or house rented from local authority
Other
(Please specify)_________________________________________
9. Educational level (highest achieved):
No formal
GCSE/O level or equivalent
A level or equivalent
Degree
Postgraduate
Other
(Please specify)________________________________________
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10. What is your occupation (if you are not currently working, what was your
previous occupation)?
11. If you are married or living with a partner what is your partner’s occupation?
____________________________________________________________________
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HADS
Read each item and circle one of the replies below each item which comes closest to how you have been
feeling during the past week. Don't take too long over your replies; your immediate reaction to each item will
probably be more accurate than a long thought out response.
1. I feel tense or 'wound-up':
1.
2.
3.
4.
8. I feel as if I am slowed down:
Most of the time
A lot of the time
From time to time, occasionally
Not at all
1.
2.
3.
4.
2. I still enjoy the things I used to enjoy:
1.
2.
3.
4.
9. I get a sort of frightened feeling like
'butterflies' in the stomach:
Definitely as much
Not quite as much
Only a little
Hardly at all
1.
2.
3.
4.
3. I get a sort of frightening feeling as
if something awful is about to happen:
1.
2.
3.
4.
Very definitely and quite badly
Yes, but not too badly
A little, but it doesn't worry me
Not at all
1.
2.
3.
4.
As much as I always could
Not quite as much now
Definitely not so much now
Not at all
1.
2.
3.
4.
A great deal of the time
A lot of the time
From time to time but not too often
Only occasionally
1.
2.
3.
4.
Not at all
Not often
Sometimes
Most of the time
Definitely
Usually
Not often
Not at all
As much as I ever did
Rather less than I used to
Definitely less than I used to
Hardly at all
13. I get sudden feelings of panic:
1.
2.
3.
4.
7. I can sit at ease and feel relaxed:
1.
2.
3.
4.
Very much indeed
Quite a lot
Not very much
Not at all
12. I look forward with enjoyment to things:
6. I feel cheerful:
1.
2.
3.
4.
Definitely
I don't take as much care as I should
I may not take quite as much care as ever
I take just as much care as ever
11. I feel restless as if I have to be on the move:
5. Worrying thoughts go through my mind:
1.
2.
3.
4.
Not at all
Occasionally
Quite often
Very often
10. I have lost interest in my appearance:
4. I can laugh and see the funny side of things:
1.
2.
3.
4.
Nearly all the time
Very often
Sometimes
Not at all
Very often indeed
Quite often
Not very often
Not at all
14. I can enjoy a good book or radio or TV programme:
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1.
2.
3.
4.
Often
Sometimes
Not often
very seldom
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ASI
Circle the one phrase that best represents the extent to which you agree with the item.
If any of the item concern something that is not part of your experience (e.g., “It scares
me when I feel shaky” for someone who has never trembled or had the “shakes”),
answer on the basis of how you think you might feel if you had such experience.
Otherwise, answer all items on the basis of your own experience.
Very
Little
1. It is important to me not to appear nervous.
2. When I cannot keep my mind on task, I worry that I
might be going crazy.
3. It scares me when I feel “shaky” (trembling).
4. It scares me when I feel faint.
5. It is important to me to stay in control of my emotions.
6. It scares me when my heart beats rapidly.
7. It embarrasses me when my stomach growls.
8. It scares me when I am nauseous.
9. When I notice that my heart is beating rapidly, I worry
that I might have a heart attack.
10. It scares me when I become short of breath.
11. When my stomach is upset, I worry that I might be
seriously ill.
12. It scares me when I am unable to keep my mind on a
task.
13. Other people notice when I feel shaky.
14. Unusual body sensations scare me.
15. When I am nervous, I worry that I might be mentally
ill.
15
A
Little
Some
Much
Very
Much
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16. It scares me when I am nervous.
THE END!
YOU HAVE REACHED THE END OF THIS QUESTIONNAIRE BOOKLET.
THANK YOU SO MUCH FOR SPENDING THE TIME FILLING THIS IN.
YOUR RESPONSES ARE EXTREMELY IMPORTANT FOR OUR
RESEARCH.
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Date: 25/04/2010
Study Title:
Cognitive and emotional risk factors for developing postconcussional
syndrome: A prospective investigation of outcome following mild traumatic brain
injury (MTBI).
Visual Probe Task Protocol
The visual probe task will consist of 16 practice trials, followed by 2 buffer trials and 192
experimental trials. The 48 stimulus pairs will consist of 16 threat-neutral picture pairs,
16 threat-neutral word pairs, 8 neutral-neutral filler picture pairs and 8 neutral-neutral
filler word pairs which were presented four times each.
Each trial will start with a central fixation cross for 500 ms, followed by a stimulus pair
(either picture-pair or word-pair) for 500 ms and 1250 ms, with one item of each pair
presented above, and one below, the central position. Immediately after the offset
of the stimulus pair, a small arrow (probe) will appear in the position of one of the items
of the stimulus pair. The arrow will either point to the left or right. Participants are
required to press one of two response keys, as quickly and as accurately as possible, to
indicate the direction of the arrow. Inter-trial interval will be 500 ms.
Each of the 32 critical stimulus pairs will consist of a health-threat item and a control
item which lacks threat content. Half will be picture-pairs and half word-pairs (i.e., 16
threat-neutral picture pairs, 16 threat-neutral word pairs). An additional 16 neutral–
neutral stimulus pairs (half picture-pairs, half word-pairs) will be used to assess baseline
RT. Each stimulus pair will be presented four times. Picture and word trials will be
presented in mixed random order. Threat words will be health related (e.g., illness,
collapse, hospitalized) and threat pictures had comparable content to threat words (e.g.,
picture of an individual in a wheelchair corresponding to the word “paralysed”).
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Version Number: 1
Date: 25/04/2010
Study Title:
Cognitive and emotional risk factors for developing postconcussional
syndrome: A prospective investigation of outcome following mild traumatic brain
injury (MTBI).
Verbal instructions for participants
Please adjust the chair etc. so you are as comfortable as possible and make sure that
you can see the screen in front of you clearly.
When the task begins you will see a cross in the middle of the screen. Please fix your
eyes on this cross when it appears.
Following this, either 2 pictures or 2 words will appear on the screen.
Immediately following this a small arrow will appear on the screen. The arrow will either
point to the left
or to the right
.
If the arrow points to the left please press the response key marked X and if it points to
the right please press the response key marked Y.
Please press the response key as fast as you can, but try and be as accurate as
possible!
There will be 16 practice trials and then 192 experimental trials, which we will use the
data from.
Are you ready to get started?
Do you have any questions?
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