Use of CBD products by individuals with MS

Participant Information

Please read the information below before you proceed on to the survey.

Thank you for showing an interest in this study. This is a project being led by Pippa Mundy (Trainee Clinical Psychologist, University of Birmingham) alongside the West Midlands Rehabilitation Centre, Birmingham Community Healthcare NHS Foundation Trust (the sponsoring organisation of the research). The research has HRA ethical approval (311720).

Who are the Research Team? 

Dr. Theresa Powell (Chief Investigator, Principal Investigator, and Academic Supervisor), Pippa Mundy (Trainee Clinical Psychologist), Dr. Sudha Balakrishnan (Consultant in Rehabilitation Medicine), Dr. Gary Law (Associate Professor in Clinical Psychology) and Mr Conor Wood (Research team).

Background to the Research

As you may be aware, the popularity of CBD and its claimed health benefits has led to numerous CBD products being available to buy over the counter. This has led to an increase in interest and curiosity about how it could help different patient groups. Whilst it has been suggested anecdotally (by both people with MS and clinicians) that CBD oil may have positive effects for individuals with MS, no clinical trials to date have been conducted to support this.

The only trials that have been carried out relate to Sativex. Sativex is an oromucosal (absorbed into the lining of your mouth) spray, containing THC. It is licensed to relieve spasticity for people with MS. Thus, the focus of this research will be on over the counter CBD products (which only contain minute amounts of THC), in order to provide much needed information regarding the perceived physical, emotional and cognitive benefits that CBD specifically has for people with MS. 

Can I take part?

If you fulfil these criteria, your participation in this study would be most appreciated. Please only continue if you:

-          Are aged 18 or over

-          Can read and understand written English

-          Live in the United Kingdom

-          Have a diagnosis of Multiple Sclerosis (MS)

-          Have experience of using legal (containing less than 1mg THC/THCV/CBN) over the counter CBD products, either currently or in the past.

We are interested your experience, whether it is positive, negative or neutral.

What do I have to do?

You will be asked to complete an online survey. Clicking Next Page at the bottom of this page will take you to a tick-box consent form confirming your willingness to participate, concluding with a final declaration statement. The survey should take you approximately 10 minutes to complete and will ask you questions regarding the reasons why you take CBD products and your experiences of taking them e.g. in relation to your physical health and mental wellbeing. Finally, you will be asked to provide some demographic information about yourself including your age, gender identity, and ethnicity. This will help us interpret the results.

Unfortunately, you will not be able to save your progress on the survey, or come back to it later, so please set aside approximately 10 minutes to complete it.

Will you be able to identify me?

No, your participation is completely anonymous. Electronic files (such as the survey data) will be stored securely on encrypted devices. To further maintain confidentiality, we will not require any personally identifiable information to be entered onto the survey platform. The data files will only be accessible to the research team. No personally identifying information will be published in the report. 

Research data will be retained by the Birmingham Community Healthcare NHS Foundation Trust for a period of ten years. After agreed periods of retention have expired and in accordance with the Birmingham Community Healthcare Information Handling Policy, electronic data will be securely erased.

What happens if I disclose any illegal CBD or cannabis usage?

The survey is anonymous so we cannot identify you. Given the survey is anonymous, the data complies with data protection and any disclosure will only be included in the analysis if it is directly relevant to the research question and can be integrated meaningfully into the results and discussion.

 Can I change my mind about taking part?

You can stop the survey at any time and your data will not be saved. However, please note that once you press FINISH SURVEY at the end of the survey, your data will be saved and you will not be able to withdraw from the study.

General Data Protection Regulations (GDPR)

We, as Birmingham Community Healthcare NHS Foundation Trust researchers, are responsible for looking after your information and using it properly. We will store the anonymised research data securely at the Birmingham Community Healthcare NHS Foundation Trust for 10 years after the end of the study. This is in accordance with the Birmingham Community Healthcare Information Handling Policy. 

Further information about your rights with respect to your personal data is available at https://www.bhamcommunity.nhs.uk/privacy-notices

How will my data be used?

All data from the survey will be extracted and analysed using an NHS computer connected to an NHS secure server in order to answer the research question. The results from this research will be written up into a thesis report. The thesis may be submitted for publication in a professional journal, available to a large amount of people. You can opt-in to receive a summary of the research findings if you wish. 

Further information about how your data during this research is used is available at https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/data-protection-and-information-governance/gdpr-guidance/templates/template-wording-for-generic-information-document/. 

What are the benefits to me in taking part?

We believe that this research will help clinicians understand more about CBD products and how they might benefit those with MS. By taking part, you will be helping to expand the scientific evidence for CBD in MS care.

Are there any risks to me in taking part?

Whilst we don’t believe the survey is particularly intrusive or sensitive in nature, we acknowledge that thinking about the symptoms or the impact of your MS may be distressing or worrying for you. Remember, you can stop the survey at any time without your data being saved. Please contact the support organisations we have listed below if you need further support.

Support organisations I can contact:

Multiple Sclerosis Organisations:

MS Society

www.mssociety.org.uk

0808 800 8000

MS UK

www.ms-uk.org

0800 783 0518

Overcoming MS

www.overcomingms.org

Multiple Sclerosis Trust

www.mstrust.org.uk

0800 032 38 39

Shift MS

www.shift.ms/about-us

Medical and Wellbeing Support

If you have concerns or questions about your MS, please consult your MS clinical team or your GP.

For wellbeing/mental health support, you can also contact your GP. Alternatively, you can contact:

Samaritans (24/7 helpline for anyone experiencing emotional distress)

116 123

jo@samaritans.org.uk

Mind – mental health charity

www.mind.org.uk

0300 102 1234 (9pm-6pm Monday-Friday)

Who can I contact for more information?

Pippa Mundy 

(Trainee Clinical Psychologist, University of Birmingham and Birmingham Community Healthcare NHS Foundation Trust)

philippa.massingberd-mundy@nhs.net

Dr Theresa Powell

(Consultant Clinical Psychologist, Research and Innovation Lead, Adult and Specialist Rehabilitation Division, Birmingham Community Healthcare NHS Foundation Trust)

theresa.powell1@nhs.net

Dr Sudha Balakrishnan

(Consultant in Rehabilitation Medicine, Birmingham Community Healthcare NHS Foundation Trust) 

sudha.balakrishnan1@nhs.net.