Ethics Proposal

Version 1. 25/04/10 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 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? Version 1. 25/04/10 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?

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. Version 1. 25/04/10

Where can I get more information?

You can contact the researcher, Nicola Rist: [email protected] or the research supervisor, Prof. Rona Moss-Morris: [email protected]. Version 1. 25/04/10

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. Version 1. 25/04/10

______

Name of Participant Date Signature

______

Name of Person Date Signature taking consent

When completed, 1 for participant; 1 for researcher site file. Version 1. 25/04/10

[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.

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 [email protected].

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: [email protected] Or The Samaritans, who offer a confidential helpline – Tel: 08457 909090 Email: [email protected]

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. 8 P1 Version Number: 1

Date: 25/04/2010

9 (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.

Thank you very much for your time

PARTICIPANT ID ______

DATE(dd/mm/yy) ______

10 P1 Version Number: 1

Date: 25/04/2010

11 Sociodemographic Questionnaire

1. Are you? Male Female

2. How old are you? ______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

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

Date: 25/04/2010 Not stated

5. What is your marital status? (see over) Single

Married

Living with a partner

Separated

Divorced

Widowed

6. Who do you live with? Husband/wife/steady partner

Spouse/partner and children

Parents

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

(Please specify)______13

9. Educational level (highest achieved): No formal

GCSE/O level or equivalent

A level or equivalent

Degree

Postgraduate

(Please specify)______

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? ______

Date: 25/04/2010

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.

15 Version Number: 1

Date: 25/04/2010 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.

A Very Li Very Some Much Little ttl Much e 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.

Date: 25/04/2010 14. Unusual body sensations scare me. 15. When I am nervous, I worry that I might be mentally ill. 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.

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”).

Date: 25/04/2010

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?