Differential Contributions of Online Stress and Pain-explicit Mindfulness Treatment Groups to Processes, Patient Experience and Outcomes in Chronic Pain: A Randomized Controlled Trial and Qualitative Analysis
Phase: NA
Conditions: Chronic Pain
Sponsor: Government of Jersey

Reference: 2020HCSREC04  
 
N.B. please note that the discrepancy in date highlighted in my previous submission 
is related to the fact that, whilst we initially on 21 February 2019 (I have amended the 
date to this), then again in August 2019 for simplification. However, the study was 
submitted to the Ethics Research board for amendments again on 24/05/2022 (this 
was the date initially submitted as was the final submission for the currently approved 
document) because operationally and due to covid we have had to delay the start of 
the study and change to online provision (hence why I initially entered this date), for 
their meeting on 26/05/2022 and their confirmation of approval on 30/05/2022 (email 
evidence included below)  
 
Title: Differential contributions of stress and pain-explicit 
mindfulness treatment groups to processes, patient experience 
and outcomes in chronic pain. A randomized controlled trial 
and qualitative analysis 
 
 
From: HCS Research Ethics Committee <HCSResearchEthicsCommittee@gov.je>  
Sent: 30 May 2022 13:48 
To: Alessio Agostinis <A.Agostinis@health.gov.je> 
Cc: Julia Morris <julia.morris@health.gov.je>; Jonathan Bond 
<J.Bond2@health.gov.je>; Moyra Journeaux <m.journeaux@health.gov.je> 
Subject: RE: minor/major amendments for Committee's attention Ref: 
2020HCSREC04 AA 
 
Hello Alessio, 
 
Following the HCS REC meeting on Thursday 26 May , I am pleased to inform you 
that your amendment to the study: 
 
Reference: 2020HCSREC04 
 
Title: Differential contributions of stress and pain-explicit mindfulness treatment 
groups to processes, patient experience and outcomes in chronic pain. A randomized 
controlled trial and qualitative analysis  
 
Was noted with no ethical issues. 
 
Please keep this email as a record of the HCS REC confirmation that there are no 
ethical issues. 
 
Many thanks, 
Aoife 
Dr Aoife Journeaux | MB BCh BAO 
HCS REC Administrator  
E: HCSResearchEthicsCommittee@gov.je  

 
HSSD Research Ethic’s Committee v2018  
Page 2 of 68 
 
 
I occasionally send work emails outside the hours of 8:30 am- 5:30pm Monday to Friday.  If you do 
receive an email from me there is no expectation of a reply outside your normal hours. 
 
Please note: the HCS REC Email box is checked once a week. Your email may not be responded to 
immediately. 
 
 
 
 
 
From: Alessio Agostinis  
Sent: 24 May 2022 14:01 
To: Moyra Journeaux <m.journeaux@health.gov.je> 
Cc: Julia Morris <julia.morris@health.gov.je>; Jonathan Bond 
<J.Bond2@health.gov.je> 
Subject: minor/major amendments for Committee's attention 
 
Dear  Moyra, 
 
We are requesting  to go from face to face to online delivery. Nothing else. We have 
amended the Ethics form to reflect.  
 
We decided to go online mainly due to covid at the time, but since then Breathworks 
also offered to have one of their teachers help us out with it (meaning half the 
workload and less impact on our clinic). I can’t remember if I checked about it being a 
minor or major amendments. In any case, I cannot find a minor amendments form 
and can’t recall if we discussed it or emailed about it, when we were considering 
changing.  
 
See attached. I understand you are meeting this Thursday (for minors might be ok) 
and then in July. We are keen to start as we have delayed for so long and I am also 
in the process of moving on from my pain clinic role (in the next 12-15 months). We 
would most appreciate the committee’s consideration of this and really sorry about 
being so late in submitting.  
 
With kindest regards 
 
Alessio  
 
  
Dr Alessio Agostinis 
Consultant Clinical Psychologist 
  
Direct +44 (0)1534 444669 

 
HSSD Research Ethic’s Committee v2018  
Page 3 of 68 
 
  
Government of Jersey 
Pain Management Centre 
Overdale Hospital 
Westmount Road| St Helier | 
Jersey | JE1 3LP  
  
 
 
 
   
 
 
 
 
 
 
 
 
 
Application Pack  
HSSD Research Ethic’s Committee 
Application for HSSD Research Ethical Approval  
 

 
HSSD Research Ethic’s Committee v2018  
Page 4 of 68 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version: January 2018 
Approved By: HSSD Research Ethics Committee 
Review Date: One year  
 

 
HSSD Research Ethic’s Committee v2018  
Page 5 of 68 
 
Health & Social Services Department 
Research Ethics Committee  
 
 
Confidential 
 
PLEASE NOTE: 
 
Please read this form and accompanying notes before attempting to complete it in order to 
avoid unnecessary duplication of answers. 
 
This form is intended to be used for HSSD research proposals: 
• 
Proposed projects where participants are accessed via HSSD 
• 
Proposed projects where investigator/researchers are employees of HSSD 
• 
Proposed projects that will be sponsored by HSSD 
 
Projects that are part of a multi-centre trial that have already received Multi-centre Research 
Ethics Committee (MREC) approval, please also supply a copy of the full MREC 
application and approval as an appendix 
 
Projects that are part of an academic programme where ethical opinion will also be required 
from a university Research Ethics Committee (REC), please also supply a copy of the full 
university Research Ethics application and approval as an appendix 
 
 
 
 
• Please complete all sections of this from.  Where a section is not relevant to the 
proposed research project, please write "n/a” in the space provided. 
 
• Cross-referencing of answers is not acceptable e.g. responses such as "refer to 
protocol" or "see above” must be avoided. 
 
 
• Please see supplementary notes for applicants (at the end of this application form) for 
guidance on completing the research ethics application form 
 

 
HSSD Research Ethic’s Committee v2018  
Page 6 of 68 
 
• Please note that a favourable opinion from the HSSD Research Ethics Committee does 
not constitute permission to carry out a research project. A favourable opinion means 
that the HSSD Research Ethics Committee is satisfied that ethical issues in planning 
the research project have been addressed to the satisfaction of the committee. 
Permission to carry out research still has to be obtained from the research site and 
department head. 
 
• Please note that research being undertaken as part of an academic programme of 
study can only be granted HSSD Research Ethics approval pending a favourable 
opinion being granted by the university faculty REC. A record of this will need to be 
forwarded to the HSSD REC prior to commencing the research project in Jersey. 
 
 
 
 
 
 

 
HSSD Research Ethic’s Committee v2018  
Page 7 of 68 
 
 Health & Social Services Department 
Research Ethics Committee  
 
Applicant’s Checklist 
 
 
Title of Study: 
Differential contributions of stress and pain-explicit mindfulness treatment 
groups to processes, patient experience and outcomes in chronic pain. A 
randomized controlled trial and qualitative analysis  
Lead 
researcher: 
Dr Alessio Agostinis 
 
• 
This document MUST be completed and submitted as part of the application form. 
Please ensure ONE copy of each document, as detailed below, is attached as an 
appendix to this application form in the order that they appear on the list. ALL 
appendices MUST have dates and version numbers clearly marked. 
 
• 
Indicate ‘yes/no’ as applicable, and continue your document list on a separate 
continuation sheet if necessary. 
 
Document 
Enclosed? 
Appendix № 
Version № 
Date 
Applicant’s Checklist (this form) 
Mandatory 
 
 
 
HSSD Research Ethics application 
form 
Mandatory 
 
      
      
List of references (APA format) 
Mandatory 
1 
      
      
Summary C.V. for lead researcher 
Mandatory 
2 
 
 
Letter(s) of invitation to participants/ 
Advert  
Y 
 / N 
 
3 
      
      
Participant Information Sheet(s)  
Y 
 / N 
 
4 
      
      
Participant and treatment provider 
consent form(s) 
Y 
 / N 
 
5 
      
      
Course facilitators conent form 
Y 
 / N 
 
 
      
      
Written permission(s) from relevant 
personnel/organisation (eg. to use 
facilities and/or access participants) 
Y 
 / N 
 
6 
      
      
Interview schedule(s) or topic 
guide(s) 
Y 
 / N 
 
      
      
      

 
HSSD Research Ethic’s Committee v2018  
Page 8 of 68 
 
Validated questionnaire(s) 
Y 
 / N 
 
      
      
      
Non-validated questionnaire(s) 
Y 
 / N 
 
      
      
      
Gannt Chart/Timeline 
Y 
 / N 
 
      
      
      
Copies of recruitment advertisement 
material(s) 
Y 
 / N 
 
      
      
      
Risk Assessment form(s) 
Y 
 / N 
 
7 
      
      
Copy of CRB Certificate (if 
applicable) 
Y 
 / N 
 
8 
      
      
Signature of Supevisor(s) OR line 
manager 
Y 
 / N 
 
9 
      
      
Have you signed and dated form? 
Y 
 / N 
 
10 
      
      
Other documents 
(Please specify below, as necessary) 
Y 
 / N 
 
 
 
 
      
Y 
 / N 
 
      
      
      
      
Y 
 / N 
 
      
      
      
      
Y 
 / N 
 
      
      
      

 
HSSD Research Ethic’s Committee v2018  
Page 9 of 68 
 
 Health & Social Services Department 
Research Ethics Committee  
 
Application for Research Ethical opinion of a Proposed Research Study 
 
Part 1 Applicant details 
 
Applicant name: 
Dr Alessio Agostinis 
 
 
Student or staff member?: 
Staff Member 
 
 
Programme of study or staff 
department: 
Pain Clinic 
 
 
New application: 
 
 or           
Resubmission: 
X 
(Please  X  in appropriate box) 
 
 
Title of study: 
Differential contributions of stress and pain-explicit mindfulness 
treatment groups to processes, patient experience and outcomes 
in chronic pain. A randomized controlled trial and qualitative 
analysis 
 
 
Application version: 
1.1 
 
 
Date of application: 
01/02/2019 
 
 
Date of REC meeting to which 
application is being 
submitted: 
 
21/02/2019 
 
 
• Applicants who are intending to complete the proposed research as part of an 
academic programme MUST discuss their proposal with their supervisor and have it 
signed off before submitting the application for ethical review.   
 
For office use: 
HSSD REC reference number  
 
 
_______________________ 
 
Reviewer 1   
 
_  ______  _____   Reviewer 2   
 
 
_______________ 

 
HSSD Research Ethic’s Committee v2018  
Page 10 of 68 
 
• HSSD employees (where the proposed research project is not part of an academic 
programme) MUST discuss their proposal with their Head of Department and have it 
signed off before submitting the application for ethical review.   
 
• 
Once you have completed your application form, and it has been signed by you and 
your Supervisor/Head of Department, please submit ONE copy of your application and 
all 
appendices 
(as 
detailed 
on 
the 
applicant 
checklist) 
by 
email 
to: 
L.delaCour@health.gov.je or by post to: Reverend Maureen Turner, Secretary - Health 
& Social Services Research Ethics Committee, General Hospital, Gloucester Street, St 
Helier. 
 
• 
Applications must be received by 4pm on the submission deadline. 

 
HSSD Research Ethic’s Committee v2018  
Page 11 of 68 
 
Health & Social Services Department 
Research Ethics Committee  
 
 
 
I confirm that: 
 
• The information in this application is, to the best of my knowledge, accurate and I 
take full responsibility for it; 
• I undertake to abide by the ethical principles embodied in the good practice 
guidelines identified in this application; 
• I will not start data collection until all relevant ethical opinions are in place including 
university faculty REC, IRAS, NRES, or MREC as appropriate. 
• If the research is approved, I undertake to adhere, without deviation, to the study as 
outlined in the application; 
• If I need to make any changes to the study, including to the timescale, I will inform 
the HSSD Research Ethics Committee before implementing any changes. Where 
the study is part of an academic programme, I will also seek advice from the 
university faculty REC; 
• I am aware of my responsibility to be up-to-date and compliant with the 
requirements of the law and relevant guidelines relating to data security; 
• I understand that personal data about me as a researcher and this application will 
be held by the HSSD Research Ethics Committee and that this will be managed 
according to the principles established in the Data Protection (Jersey) Law 2005; 
• I will provide a brief end of project report to the HSSD Research Ethics Committee 
on the completion of my project; 
• I will advise the HSSD Research Ethics Committee of any publications that are a 
product of the study. 
 
 
Name: 
Dr Alessio Agostinis 

 
HSSD Research Ethic’s Committee v2018  
Page 12 of 68 
 
Signed: 
 
Date: 
07/08/2019 
 
 
• Please ensure that your academic supervisor/line manager has seen and agreed to 
support this proposal; they must sign this form to indicate they are happy for the 
proposal to be submitted. All relevant signatures must be obtained before submitting 
this application. Failure to have all the required signatures will result in your 
application being returned to you, which may delay your review. 
 
• Applicants should note that it is their responsibility to submit their proposal in sufficient 
time, particularly when working to tight/strict deadlines. This includes allowing 
adequate time prior to submission for the supervisor/line manager to read the proposal, 
provide feedback, and review any amendments before agreeing to support the 
proposal and signing the application form overleaf. 
 
Please note:One of the bleow must be completed before an application can be 
accepted 
 
Approval from Academic Supervisor 
 
I confirm that the applicant has discussed their research proposal with me, and that I have 
read and agree to support this application. 
 
 
 
Name: 
Insert supervisor's name here 
Signed: 
 
 
Date:  
 
 

 
HSSD Research Ethic’s Committee v2018  
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OR 
 
 
 
Approval from Line Manager 
 
I confirm that the applicant has discussed their research proposal with me. I understand the 
purpose of the research and am aware of all the implications (including time) that 
conducting this research may have. I am in agreement with the research and support this 
application.  
 
 
 
Name: 
Dr Chad Taylor, Pain Clinic Lead 
 
 
Signed: 
 
 
 
Date:  
07/08/2019 
 
 
 
 

 
HSSD Research Ethic’s Committee v2018  
Page 14 of 68 
 
  
Health & Social Services Department 
Research Ethics Committee  
 
Application Form 
 
Part 2: 
Introduction  
 
 
1.     Title of research project 
Differential contributions of stress and pain-explicit mindfulness treatment groups to 
processes, patient experience and outcomes in chronic pain. A randomized controlled
trial and qualitative analysis 
 
 
2. 
Project Details 
 
Project location: 
Jersey 
Project duration: 
24 months  
Expected start date: 
July 2022 
Expected end date: 
    April 2024 
 
 
3. 
Lead researcher (the applicant) 
NB. The lead researcher must submit a copy of their current CV (max. 2 sides of A4) with this application. 
 
Name of applicant: 
Dr Alessio Agostinis 
Status:  (eg.MSc student; Doctoral student; staff
researcher; other – please specify) 
Consultant Clinical Psychologist and Staff Researcher 
Address for correspondence: 
Pain Management Centre, Overdale Hospital, Westmount 
Road, Westmount, Jersey JE2 3LP 
Contact telephone number: 
01534444669 
Contact email address: 
    a.agostinis@health.gov.je  
Professional position  
(if applicable): 
Consultant Clinica Psychologist (SOJ),  
Honorary Visiting Research Associate Liverpool John Moores
University 

 
HSSD Research Ethic’s Committee v2018  
Page 15 of 68 
 
Experience of research methods: 
Degree in Applied Psychology (inc. research methods and 
analysis and qualitative thesis) Doctoral Training Qualification
in Clinical Psychology (including published quantitative 
thesis), various audit, research posters/projects, presentation 
at conferences; research methods study throughout both 
degrees and ongoing learning.  
 
 
4. 
Other individuals who may work on the research project 
NB. If there are more than two additional researchers, please note their details on a separate sheet and 
append to this application. A summary CV (max. 2 sides of A4) for each additional person must accompany 
this application. 
 
Name: 
Dr Ben Rosser  
Status: (eg. research supervisor; clinical 
supervisor; researcher; 
statistician) 
Researcher 
Clinical Psychologist & Lecturer, Natural Sciences & 
Psychology, Liverpool John Moores University 
Contact telephone number: 
0151 904 6298 
Contact email address: 
B.A.Rosser@ljmu.ac.uk 
Name: 
Mr Jonathan Bond 
Status: (eg. research supervisor; clinical 
supervisor; researcher; 
statistician) 
Assistant Psychologist, Research Assistant 
Contact telephone number: 
0153445609 
Contact email address: 
J.Bond2@health.gov.je  
Name: 
Dr Nigel Minihane 
Status: (eg. research supervisor; clinical 
supervisor; researcher; 
statistician) 
Primary Care Board Lead and GP 
Contact telephone number: 
01534833821; 07797713081 
Contact email address: 
minihane@gmail.com   
Name: 
Colin Duff 
Status: (eg. research supervisor; clinical 
supervisor; researcher; 
statistician) 
Business and Research Manager, Breathworks CIC 
Treatment Integrity 
Contact telephone number: 
0161 834 1110 
Contact email address: 
colin.duff@breathworks.co.uk  

 
HSSD Research Ethic’s Committee v2018  
Page 16 of 68 
 
 
 
5. 
Academic supervision: (if proposed research is part of an academic programme of study) 
 
 
Primary supervisor: 
 
 
Email address: 
 
 
 
Type academic supervisor's name here 
 
Type email address here 
 
Additional supervisor(s): 
(if relevant): 
 
Email address: 
 
 
 
Type any other supervisors' names here 
 
 
Type email addresses here 
 
 
 
6. 
Who is sponsoring the proposed research? 
 
 
Eg. University, HSSD Head of Department/Consultant, pharmaceutical company, device 
manufacturer, charity or other organisation 
 
Dr Chad Taylor, Pain Clinic Consultant and Lead (HCS); Breathworks Foundation has agreed 
to supply one teacher to provide three courses online alongisde a local teacher, to help 
minimise the impact on our clinical delivery We have also submitted a research grant 
application. The latter has since been 
declined.(Clulow)__________________________________________________________________
 
If the proposed research is sponsored by a pharmaceutical company, has that company agreed to 
abide by: 
 
I. 
The Association of the British Pharmaceutical Industry Guidance on Insurance and 
compensation in the event of injury in Phase 1 clinical trials 2012 (patient studies)? 
 
   Yes                         
   No 
 
 
II. 
The Association of the British Pharmaceutical Industry Guidelines for Phase 1 Clinical Trials 

 
HSSD Research Ethic’s Committee v2018  
Page 17 of 68 
 
2012? 
 
   Yes                         
   No 
 
 
 
 
 
 
 
 
 
 
 
 
7. 
Good research practice: 
Please confirm that the research will be carried out in accordance with the 4 Ethical Principles of 
Research – autonomy, beneficence, non-malificence and justice and in accordance with recognised 
standards of practice as in the Declaration of Helsinki 
 
 
I agree to undertake the proposed research, as outlined in this application, in accordance
with the 4 Ethical Principles of Research and the Declaration of Helsinki. 
 
Please state which other professional codes of conduct you will abide by (if applicable): 
 
Type your statement of practice here 
 
 
 
8. 
Will you require ethical opinion from another source? 
 
 
   Yes                         
   No 
 
If Yes, which other ethics committee approval do you require? i.e. university faculty REC, MREC etc. 
___________________________________________________________________________________________________________ 
 
 
 

 
HSSD Research Ethic’s Committee v2018  
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Part 3: 
The research 
 
1. Type of research proposed: 
Please indicate whether the proposed research is: 
   Quantitative 
 Qualitative 
Both 
If other please detail: 
 
 
 
2. Outline of the research: 
Please provide a brief outline of the proposed research under the sub-headings below. 
N.B. below we included a scientic and lay person abstracts for your assistance as by way of 
introducing the project briefly. 
 
200-word lay abstract 
Mindfulness is a popular set of knowledge and practical techniques that can help people cope 
with stress. It includes meditation practices, everyday small practices to break and change usual 
habits, as well as understanding and developing competencies to be more aware of thoughts, 
emotions and physical sensations. Mindfulness can help not to excessively react to them, or 
becoming distressed by them. 
 
In persistent pain (pain that lasts more than three months), mindfulness is thought to improve 
depression, quality of life, and even how sore people feel.  
 
There are numerous versions of mindfulness and mindfulness-based therapies. One approach,  
Acceptance and Commitment Therapy (ACT), is based on science (as opposed to religion or 
common sense). ACT helps people to learn about and apply skills to cope with thoughts, 
emotions and sensations without getting upset, distracted or impeded by them. It also assists 
people to develop the ability to set clear goals that matter in their life. ACT evaluates successful 
outcomes in this areas (called ‘processes’) and how they link to changes in pain, mood and 
stress. However, more puritan mindfulness courses tend to only focus on the latter. 
 
Research on mindfulness courses for chronic pain, can show that people improve, but not so 
well what changes in people’s experience and skills, or how they apply these.  We also know 
that pain sufferers who attend mindfulness courses for stress, may say it is not so relevant to 
their pain difficulties. 
 

 
HSSD Research Ethic’s Committee v2018  
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In this study we want to explore how both mindfulness for stress and mindfulness for pain 
courses, online, contribute to: 
- 
 how specific areas of ACT and other mindfulness learning change  
If/how these link with practical skills and any emotional or improvements in the participants’ 
quality of life, use of medication or GP visits. To help us evaluate this, we will ask participants to 
complete scientifically accepted questionnaires and interview them. We will then use statistical 
methods and qualitative methods to evaluate change.   
 
This may help us with better supporting chronic pain sufferers with choices around mindfulness 
as a standalone or as part of attending intensive pain-coping programmes involving different 
professions. 
 
Scientific abstract of the work proposed 
In chronic (persistent) pain, mindfulness can improve coping, depression, quality of life, and 
reduce pain intensity. Both Acceptance and Commitment Therapy (ACT; Hayes, Strosahl et al. 
1999) and mindfulness research, including Mindfulness Based Stress Reduction (MBSR, Kabat-
Zinn 1982) and Mindfulness Based Cognitive Therapy (MBCT, Segal, Williams et al. 2002) 
provide theoretical and/or practical frameworks for mindful process measurement.  
 
However, numerous methodological and contextual limitations exist within the context of pain 
management centres that are increasingly providing mindfulness based interventions to pain 
sufferers.  This has potential implications for whether implementing mindfulness skills is done 
with clarity, good governance about whether, where and how it is helpful, or whether it even can 
be harmful, duplicate other treatments or unnecessarily burden pain sufferers with something 
that is not needed. In this context, it also has significant implications on any required 
development of teachers’ competencies.  
 
No current research has attempted to unify ACT and other mindfulness process measurement 
(how people get to change – as opposed to what change they achieve) or to establish the 
potential contribution and relevance of different specific mindfulness courses in chronic pain 
patients’ treatment pathways and outcomes. 
 
A community-based multidisciplinary-pain-management naïve sample (N=100) of chronic pain 
patients will be recruited in primary care and placed on a time-set waiting list and then randomly 
allocated to one of two standardised active online mindfulness treatments - stress or pain group 

 
HSSD Research Ethic’s Committee v2018  
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conditions. Measurement will include theoretically validated process and outcome measurement. 
Treatment adherence and fidelity will be independently evaluated from recorded sessions and 
inter-rater agreement checks performed.  
 
Quantitative analysis will be performed to include descriptive statistics, analysis of variance, 
session-by-session process change trends, and post-hoc analysis on GP and A&E visits. 
 
Qualitative thematic analysis will complement and bolster the findings of the quantitative phase 
to include additional process variables unaccounted for by the ACT model, patient experience 
and descriptive comparison of the two active conditions, including descriptive statistics 
comparing frequency of reported themes between the two treatments. 
 
i. 
Aims and objectives: 
 
This study aims to explore and better understand the contribution of standardised group-based 
mindfulness courses to theoretically valid and coherent mindful-change processes.  
OBJECTIVES 
1. To explore the differential contribution of standardised stress and pain-explicit group-
based mindfulness courses on mindful-change process as  described in the Acceptance 
and Commitment Therapy (ACT) psychological flexibility model (Hayes, Strosahl et al. 
1999) on a chronic pain population that is naïve to multidisciplinary pain treatment. 
2. To improve on methodological and confounding issues inherent in current research on 
mindfulness for chronic pain. 
3. To contribute to the understanding of the potential relevance and role of standardised 
stress and pain explicit mindfulness courses in chronic pain treatment outcomes and 
pathways. 
 
 
 
 
 
a. Hypotheses and/or research question(s) to be addressed: 
 

 
HSSD Research Ethic’s Committee v2018  
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Quantitative project 
What is the differential contribution of online stress and pain explicit mindfulness courses to 
mindful-change process variables and outcomes? More specifically: 
 
What individual contribution do mindfulness for stress (MfS; Hennessy 2017) and Mindfulness 
for Health – Mindfulness Based Pain Management (MfH-MBPM; Burch and Penman 2013) 
courses make to Acceptance and Commitment Therapy (ACT) processes and relevant chronic 
pain outcomes in pain-management-naïve chronic pain sufferers?  
Which associations exist between weekly course content and specific process change?  
 
Qualitative project 
Given consideration of: 
a) The practical impossibility of quantitatively measuring all the relevant process variables,  
b) The potential questionnaire burden, and  
c) The sheer number of processes and mechanisms contained within both ACT and chronic 
pain literature on mindfulness courses and meditation,  
we aim to utilise thematic analysis to complement the quantitative findings. This will allows us to 
explore the impact of both versions of courses, reduce questionnaire burden in the quantitative 
analysis, and contribute to answering the following questions.  
a) Which relevant ACT-process variables are reported by participants and how have they 
changed?  
b) Do participants report the presence of other contributing variables considered within the 
mindfulness-groups literature in chronic pain, such as group cohesion, engagement and 
the impact of teachers’ experience on reported change? 
c) How frequently are these variables reported across the two groups, and in which 
direction? (improvement/deterioration/no change). This component will take the form of 
descriptive statistics and qualitative comparison of occurrence within patients’ interview-
derived themes. 
 

 
HSSD Research Ethic’s Committee v2018  
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ii.     Rationale, to include a brief synopsis of the background to the research: 
Mindfulness can be defined operationally as Paying attention; on purpose in the present moment 
and non-judgmentally (Kabat-Zinn 2013) 
 
Evidence-based (often referred to as ‘secular’) mindfulness has seen an exponentially 
increasing interest in the scientific literature and the estimated number of published scientific 
journals has recently been reported to have grown from one single journal in 1982, to 667 
scientific publications in 2016 (Kabat-Zinn 2017) and in excess of 30,000 Media Pieces in 
Newspapers (Van Dam, van Vugt et al. 2018)  
 
(extract from Kabat-Zinn 2017) 
However, there are unknowns around the mechanisms (the ‘vehicles’ of change) by which 
mindfulness works, and that these must be understood in order to avoid continued professional 
and public misinformation, poor research and ultimately, potential harm to the end user. (Van 
Dam, van Vugt et al. 2018).  
 
ISSUES WITH AND IMPLICATIONS OF WHAT WE CURRENTLY DEFINE AS MINDFULNESS 
AND ITS APPLICATION TO CHRONIC PAIN 

 
HSSD Research Ethic’s Committee v2018  
Page 23 of 68 
 
 
Within the context of the exponential growth of interest in and research of mindfulness (e.g. 
Kabat-Zinn 2017, Van Dam, van Vugt et al. 2018) including in the treatment of chronic pain 
(Bawa, Mercer et al. 2015, Hilton, Hempel et al. 2017), several factors have contributed to the 
consideration for the current project: 
1. The integration of mindfulness based interventions in gold-standard multidisciplinary 
treatments for chronic pain, such as ACT (BPS 2013),  
2. Researchers’ calls to improve intention to treat, to better understand facets of what is 
understood to be mindfulness, better targetting of and a more unified approach to 
mindfulness-change process variables – thus aiming to reduce treatment burden. 
3. There are relevant mindful mechanisms and processes specifically in chronic pain that 
have made a case from both the ACT and the more purist mindfulness research derived 
from group based interventions or meditation alone in chronic pain – and that are not 
currently typically or routinetly  included in mindfulness groups research for chronic pain.  
4. Methodological issues including  
a. lack of clarity about providers’ competencies and requirements in chronic pain, 
b.  arbitrary removal of essential components of a given intervention,  
c. often no active or waiting list control condition and  
d. no consideration at all of utilising a theoretically valid and coherent process-
measurement frameworks nor consideration for the teachers’ competencies 
requirements when delivering mindfulness courses to chronic pain patients 
(e.g. Dobkin 2008, Day, Jensen et al. 2014, Van Dam, Hobkirk et al. 2014, Day 2017, Harrison, 
Scott et al. 2017, Hilton, Hempel et al. 2017). 
 
From reviewing the evidence quoted, the research on mindfulness for chronic pain has 
exclusively utilised standardised mindfulness groups typically aimed at stress populations, 
excluded less researched pain explicit (contextually relevant to pain) mindfulness group 
interventions, ignored theoretically valid mindful-process measurement provided by the ACT 
framework, or not controlled appropriately for significant counfouding factors.   
 
This debate is increasingly important considering that recently published audit data suggets that 

 
HSSD Research Ethic’s Committee v2018  
Page 24 of 68 
 
mindfulness in one format or the other, or as part of ACT-based multidisciplinary treatment is 
being provided regularly in pain management centres in the UK . This has been leading, 
possibly premautrely, to discussion about providing training in mindfulness competencies for 
pain practitioners such as mindfulness enquiry or leading meditations (e.g. Williams, Watson et 
al. 2017), which may lead, in turn, to implementing professional skills without sound, targetted 
and theoretically evidenced rationale.   
 
METHODOLOGICAL ISSUES WITH CURRENT MINDFULNESS RESEARCH AND THE 
IMPROVEMENTS WITH THIS STUDY 
 
The current research will therefore aim to address and control, some of the currently reported 
methodological issues in research on group mindfulness based interventions (MBIs), including:  
- 
Utilising a waiting list for the whole group as a control prior to randomisation. This will act 
as a pseudo treatment-as-usual condition and will track key outcome and process 
measures across this time. 
- 
Utilising two active interventions, Mfs and MfH-MBPM, with standardised, transparent, 
comparable in content, time and delivery process that can therefore be easily evaluated 
for adherence and treatment fidelity. 
- 
Using established and matched teacher’s competence in line with UK Network standards 
(MBTT 2011)for the intervention delivered. 
- 
Utilising the same ‘dosage’ and type of interventions (groups with similar structure, 
delivery times and requirements for practice) utilising MfH-MBPM and MfS  (Burch and 
Penman 2013, Hennessy 2017) 
- 
Using appropriate psychometric and qualitative analysis and targetting of explicit 
process-change.    
- 
Reporting adverse side effects 
- 
Measures in line with IMMPACT recommendations for research on chronic pain 
(Dworking et al., 2005). 
 
iii. 
Study design, to include recruitment and sampling strategy, inclusion/exclusion 
criteria, sample size and justification: 

 
HSSD Research Ethic’s Committee v2018  
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In order to address the research questions, the current study will be divided in and 
presented as separate quantitative and qualitative components:  
 
Quantitative study: 
 
Design and Method 
DESIGN 
A waiting-list controlled, randomised, pilot trial of mindfulness based group treatment comparing 
two active standardised interventions (mindfulness for stress vs. mindfulness for pain/health) 
SETTING AND STUDY POPULATION 
An opportunity sample via general practice, waiting-room advert and GP supported recruitment 
in Jersey, serving a population of 106,000, will be invited to take part in the study.  
RECRUITMENT 
All general practices in Jersey will be invited to take part in this study. They will be recruited 
through the Jersey Primary Care Body and Social Media Advertising.  
 
CASE IDENTIFICATION 
Over a six months period.  
Once potential participants have consented, searches will be run on GP electronic health 
records to identify suitability. Demographic data including gender, age, ethnicity and 
employment status, pain diagnoses, current medication and dosage, co-morbidities and mental 
health diagnoses will be extracted via GP referral to the study, including that the patients meet 
inclusion criteria and do not meet any of the exclusions. 
 
INCLUSION AND EXCLUSION CRITERIA (PATIENTS) 
Inclusion criteria: 
1. Pain > 3 months 
2. Ability to communicate and literacy in English 
3. Age 18 years or older 
4. No current outstanding medical tests or procedures for conditions expected by the GP to 
interfere with participation in treatment.  
5. Has not previously received non-medical treatment at a specialist pain centre, or 

 
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attended a multidisciplinary pain management programme.  
6. Ability to utilise online video conferencing technology (i.e. ownership of a compatible 
device & necessary technical competence) 
Exclusion criteria: 
7. Patients who are actively suicidal, terminally ill or have dementia, cognitive impairment, 
learning difficulties, or the GP knows of another reason to exclude. 
ETHICAL ISSUES 
Informed consent 
We will obtain approval to contact practices regarding the study with participant’s information 
leaflet and GP information leaflet. We will also obtain informed consent from the treatment 
providers, including in relation to video/audio feed being recorded. Participants will be offered 
opportunity to switch off their cameras.  
 
Confidentiality 
Data will not be accessed outside the research team.  Once collected, checked for inclusion 
criteria and allocated to a randomly generated participant number, data will be anonymised and 
prior to the off-site transfer for blind analysis (the statistician will not be aware of which condition 
stress/pain the participants have been allocated to). Data Transfer Protocols will be utilised in 
line with the Government of Jersey Governance and Data Protection system, to transfer the data 
ahead of analysis.  
 
A participant waiting-list randomised, pilot trial of mindfulness based group treatment comparing 
two active interventions (stress vs pain mindfulness courses) and the waiting-list at recruitment 
time and 8-weeks post recruitment, coinciding with the start of treatment.  
 
Randomisation will be based on computer-generated random numbers and the sample 
randomised, will act as a pseudo-waiting-list control for the eight-week waiting period ahead of 
the intervention.    
 
 
Recruitment details and Participants 
PARTICIPANTS AND DATA COLLECTION 
100 people with chronic pain (defined as > three months duration) will be recruited from 
primary care and social media adverts in Jersey (the social media participants will be 

 
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required to register their interest via their GP who will then refer to the lead researcher). 
Once recruited, participants will be required to complete baseline outcome and process 
measures, 8-weeks ahead of beginning their 8-week course. Randomisation will take 
place at this point to either the stress or the pain course. They will repeat this 
assessment on week 1 of the course and then again at week 4. They will also complete 
only process measures weekly during the course, in order to explore for links between 
weekly course content and specific process change. 
Posttreatment assessment will be completed within four weeks of treamtent completion 
and at 3-month follow up.  
 
How this study will improve on previous research 
 
The current study therefore offers an opportunity to impact on the understanding, application of 
mindfulness and management of chronic pain in the following ways:    
- 
Improved targeting of mindfulness courses as part of multidisciiplinary treatment for 
chronic pain 
- 
A better understanding of  the contribution that mindfulness courses may provide in 
chronic pain patient treatment pathways, as improved understanding of their mindful-
process-change relevance, may allow improved targetting and avoid unecessary 
duplication, treatment burden or even harm. 
- 
Improving the understanding of the requirement for and development of relevant 
teaching/training competencies in mindfulness in this area.  
- 
Potentially contributing to establishing whether full mindfulness courses have a place 
(and what that is) building up to, or as part of multidisciplinary pain management 
programmes or possibly ahead of these, within the community or as an adjunct to them- 
for chornic pain sufferers.  
 
Procedure:  
100 people with chronic pain (defined as > three months duration) will be recruited from primary 
care and social media adverts in Jersey (the social media participants will be required to register 
their interest via their GP). The allocation (stress or pain) will not be concealed from the 
participants, treatment providers or the researcher. However, analysis of the data ill be 
conducted blind to allocation. Post-treatment assessment will be completed within four week of 

 
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treamtent completion and at 3-month follow up. The sample size has been determined to recruit 
8-12 participants for each of four stress and pain courses to be administered with a recruitment 
of 50 and a minimum target of 30 per active intervention.  
 
 
Qualitative study: 
 
DESIGN AND SETTING 
A qualitative study involving semi-structured interviews will be held, with a topic guide informed 
by the ACT psychological flexibility model (Hayes, Strosahl et al. 1999) and Day’s framework for 
mindfulness-relevant processes (Day, Jensen et al. 2014)in chronic pain, and based on 
mindfulness research improvement based on adaptations of Mindfulness Based Cognitive 
Therapy (MBCT) for chronic pain (Day 2017).  
 
Exclusion criteria (in addition to quantitative study criteria): 
Non-completers (participants who completed less than 6/8 course sessions) 
Declined to take part in interviews 
 
SAMPLING 
An opportunity sample from all patients invited to take part to the quantiative research aspect, 
invited as part of the intial quantitative study informed consent process. 
We will invite all participants from the sample, aiming from 10-15 participants from each the 
stress and pain version of the courses, hence a total sample of 30 participants maximum and a 
target of 10 completed interviews for each intervention.  
 
 
iv. 
Proposed method(s) of data analysis 
 
Quantitative: 
PRELIMINARY ANALYSIS 
After randomisation, we will carry out preliminary baseline analysis using independent group t-
tests to establish no signifcant demographic (age, education, duration of pain, number of 
comorbid medical conditions, visits for pain the past three months) or psychometric differences 
between the groups. This will act as a pseudo-waiting list treatment-as-usual (TAU) control 
group.  
 

 
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MAIN ANALYSIS 
Treatment process change and outcomes 
Means, Standard Deviations (SDs), between-group analysis of variance and co-variance 
(ANOVA, Between-Group ANCOVA) results and effect sizes  (Between-Group effect sizes: d) for 
pretreatment, session-by session process change tracking including a practical selection of 
accepted and validated process-change measurement for all six areas of psychological flexibility  
and outcome measurement  related to: 
- pain intensity and interference 
- impact on functioning 
- emotional functioning (depression, pain catastrohpizing) 
- Global impression of functioning 
 
for baseline, half-way,  end-of-treatment and follow up  
 
Analysis will be performed utilising SPSS.  
 
These will include a practical selection of primary outcome measures, treatment process 
measures, as well as measures of emotional functioning, patient rating of change and change in 
medication use.  
 
 
Post-hoc analysis 
Will include number of GP and A&E visits comparing the waiting period and from the end of 
treatment to follow up.  
 
STATISTICAL POWER 
This study will be a modification of a previous pilot test trial of a brief, widely inclusive UK 
primary care setting (McCracken, Sato and Taylor, 2013), to include the whole sample of 
participants acting as a waiting list control, randomly allocated to two active treatment 
conditions. In line with this study which was delivered in a population area of 119,000 people, 
power calculations were not completed, nor were formal predictions of signficant treatment 
effects. This was on the basis that the same treatment format and in a community based sample 
had not been tried before and demonstrated of successful rectuirment of > 60 participants within 
a two-month period and reporting moderate effect sizes for the active condition. Given the whole 
island population of Jersey is estimated currently at 106,000, power calculations will not be 
provided in this study as the sample size was deemed appropriate in the previous that also cited 

 
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a number of studies with similar sample sizes and obtained from populations greater than 
Jersey.  
 
PROCESS AND OUTCOME MEASURES 
Process and outcome measurement has included consideration of factors such participants’ 
burden, requirement for validated ACT and mindfulness groups process measurement  (Day, 
Jensen et al. 2014, Day 2017, Feliu-Soler, Montesinos et al. 2018), relevant recommendations 
on measurement of outcome in chronic pain  (Dworkin, Turk et al. 2005) and our current 
research team resources.  
 
Ultimately, in attempting to have a clearly targeted study, we have been unable to have 
comprehensive quantitative measurement and the qualitative analysis will go some way to 
compensate for that.  
 
Process measures: 
In line with a recent review of validated and acceptable measures of psychological flexibility in 
chronic pain (Feliu-Soler, Montesinos et al. 2018) : 
1) Acceptance  
a. The 7-item Acceptance and Action Questionnaire v.2 (AAQ-II, Bond et.al, 2011) 
will be utilised to measure the person’s change in willingness to experience 
general unpleasant feelings and emotions that are not pain related (not to unfairly 
disadvantage the stress version of the course) 
b. Pain Acceptance The 8-item Chronic Pain Acceptance Questionnaire (Fish, 
McGuire et al. 2010) 
2) Contact with the Present Moment: The Mindful Attention Awareness Scale (Brown and 
Ryan 2003) will be utilised.  
3) Self in context: The Self Experience Questionnaire (Yu, McCracken et al. 2016)(SEQ, 
Yu, McCracken & Norton, 2016) will be utlised. 
4) Cognitive fusion: the Cognitive Fusion Questionnaire (Gillander et. al, 2014)  
5) Values: The Chronic Pain Values Inventory (McCracken and Yang 2006) 
6) Committed Action: The 8-item Committed Action Questionnaire (McCracken, Chilcot et 
al. 2015) 
 
Outcome measures: 
Pain Intensity and interference on quality of life : the Brief Pain Inventory – Short Form  (Tan, 
Jensen et al. 2004), numeric rating scale (NRS) on intensity (scale 0-10) including, worst, least 

 
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average (in the past week) and right now. BPI interference scale for impact on quality of life. 
Emotional Functioning 
a. Pain related distress:  The Pain Catastrophizing Scale (Sullivan, Bishop et al. 1995) 
b. Depression: The Beck Depression Inventory – Fast Screen (Poole, Bramwell et al. 2009) 
Global Impression of Functioning: the Patient’s Global Impression of Change (Guy 1976)will 
allow to consider perceived improvement and deterioration.  
 
Qualitative: 
 
DATA ANALYSIS 
Transcribed data will be managed with NVivo software. All transcripts will be read and reread to 
ensure familiarity with the data. We will use thematic analysis(Braun and Clarke 2006) to identify 
recurring themes across the data and examine relationships between themes. The thematic 
analysis will be undertaken by two researchers independently coding for emerging themes and 
then comparing codes and themes.  
 
TOPIC GUIDE 
Do you have any previous experience in taking part in clinical trials or medical research? 
I’m really interested in finding out what were your initial expectations and feelings about the 
mindfulness course? 
What do you feel you have gained from attending the course? 
What (if any) changes have you noticed in your health/quality of life? [probe for anything getting 
better or worse: health, emotional, physical, practical] 
How do you feel the course has contributed to how you manage chronic pain?  
This study has involved you doing some reading, meditation and practices in everyday life (‘habit 
releasers’). Would you give me a sense as to whether you have managed to engage in these 
practices? [Ask about how long typically they have practiced daily formal meditation; are they 
still practising?; What has stuck and what hasn’t?] 
Is there anything else you would like to say about your experience of the course? 
How do you feel the teacher contributed to your experience of the course? 
What contribution do you feel the group has made to what you have learnt? 
 
Since attending the course: 
- 
Can you tell me if you have noticed any changes in pain? 

 
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- 
Have you started or stopped any other treatments for your pain?  [what and why] (prompt 
re prescribed and other treatments e.g. CBT/diet/complementary medicines/cannabis) 
- 
What have you noticed about your thoughts? [prompt re whether they notice their 
thoughts more or less in the past and future and whether they can bring themselves back 
to the present more or less – and how do they achieve that? ] 
- 
What would you say the course has contributed to how you respond to thoughts and 
emotions?  
- 
How has the course contributed to how you respond to pain within yourself and in what 
you do or don’t do?  
- 
What changes you have noticed in how you manage or experience bad days with pain?  
- 
How has the course influenced what you see is important to you in life?   
- 
What have you noticed in terms of whether you do or do not see important things through 
? [prompt if needed: do you notice whether you avoid important stuff has changed in any 
way? If ‘yes’, how?]  
- 
How do thoughts and feelings shape you as a person and in life?  
General prompts to be used flexibly include:  What was that like? Can you give me an example 
of that? How did you feel about that? 
 
 
 
v. 
Description of site(s) / facilities required: 
 
The study (delivery of courses and interviews) will take place online.  
 
Given the expected sample size (approximately 50 per active condition) for the 
quantitative project, it is likely there will be a requirement to run three courses twice 
per week (two stress and two pain) over eight weeks. This will be done around the 
current pain clinic requirements and At coordinated and pre-agreed times. 
 
 
3. Ethical issues: 
Please summarise what you think are the ethical issues inherent in this study. The 

 
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questions that follow will give you the opportunity to demonstrate how you will manage 
these issues in the conduct of your research. 
 
 
Potential to cause distress 
There is a chance that patients may become upset talking about chronic pain, related or 
unrelated emotional difficulties and there may be risk, during the course or the interviews. If this 
should occur, the participant will be given the option to stop the course/interview and be linked 
with the consultant clinical psychologist overseeing the project (who will be available throughout 
the duration of the courses for supervision) and, if required, case management and signposting 
to the GP or appropriate mental health services. 
Also see Risk Assessment in Appendix. In addition, the lead researcher will remain as 
contactable throughout the project and will provide advice, risk assessment and signposting 
throughout the project. At the outset of each group and as part of group agreement and rules, all 
participants will be made aware of the need to speak to the facilitators should they experience 
any significant adverse physical or emotional difficulties requiring further medical or 
psychological attention.  
 
i. 
Are there any potential risks or adverse effects to participants? 
As well as any physical risks or adverse effects, you should consider the potential for discomfort, 
distress, inconvenience or change in lifestyle for the participants, and explain how these will be 
managed. 
 
See Risk Assessment 
 
ii. 
Are there any particular requirements or abstensions that will be imposed on 
participants? (Eg. multiple attendance sessions; abstention from alcohol, tobacco, etc.). 
 
 
Participants will be required to attend all 8 sessions of the mindfulness course and will 
be classed as completers with a minimum of 6 sessions.  
 
Participants will be required to abstain from alcohol, illegal or otherwise mentally 
impairing substances. 
 
Participants will be required to keep a log of their personal-time practice, read the 
appropriate course manual/book and complete their home mindfulness practice.  
 
 

 
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iii. 
Are there any potential benefits to participants, or to the wider society? 
 
Given the evidence presented earlier and the broader evidence of mindfulness, the 
current costs of attending mindfulness courses, participants will be able to complete a 
full and Breathworks accredited Stress or Pain Course, which also provides the basis for 
future mindfulnes teacher training in line with current UK standards. These courses 
would usually retail in the region of £190-£350 per head.  
As the courses will be offered to a community sample, this will not prevent patients with 
chronic pain from accessing the current provision at the local pain management centre. 
In actual fact, it will give opportunity to more people to access both stress and pain 
coruses.  
 
Above and beyond the benefits to understanding research, they will contribute to 
furthering understanding, improving provision of pain specialist services and to pain 
professionals competency standards.  
 
The benefits of mindfulness go beyond pain and include those to the workplace, team 
working, productivity, stress and performance and general wellbeing.  
 
iv. 
Are there any potential risks or adverse effects to researchers themselves? 
 
Given the open recruitment via social media, there is the potential risk of unknown 
participants’ forensic or problematic history. However, this will be mitigated by 
requesting all participants seek to access the research project via initial contact with 
their GP surgeries.  
 
v. 
Where samples will be taken from the participant, please state which samples, 
the amount and frequency of them and whether the sample would be taken as 
part of the normal patient care or specifically for the purposes of the research? 
If a sample would normally be taken as part of usual patient care - will the 
amount taken be any greater due to the participation of the participant in the 
research? 
 
Not applicable 
 
vi. 
Where the research involves the use of radioactive isotopes, please confirm that 
the dosage proposed to be used in the research has been approved by a 
Radiological Safety Committee or Administration of Radioactive Substances 

 
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Advisory Committee (ARSAC), and that the person(s) who will administer the 
dose is/are properly qualified and hold(s) the necessary certificate(s)? 
 
Not applicable. 
 
vii. Where the research involves the testing of a medicinal product (or medical 
device), please state the regulatory status of the drug/device in question.  Is the 
research being conducted under the terms of a product licence, Clinical Trials 
Certificate (CTC), Clinical Trials Exemption (CTX) or Doctor’s and Dentist’s 
Exemption (DDX)? 
 
Not applicable. 
 
viii. Please indicate whether participants will receive payment or reimbursement for 
taking part in the research study (including reimbursement of expenses). If so, what 
amount? 
 
Not applicable.  
 
ix. 
Please state the relationship, if any, which may/will exist between the 
researcher(s) and potential participants. (Eg. will any of the participants be students, 
subordinates or colleagues of the investigator, or staff members of the University?) 
 
Not applicable. However, given the nature of Jersey, participants may be known to the 
research team, may be acquaintances or fellow colleagues. This is unavoidable.  
 
 
4. Informed consent: 
Will informed consent be obtained from the research participants? 
 
   Yes                         
   No 
 
If ‘YES’, please give details of who will obtain consent and how this will be done, 
including how long participants will have to decide whether or not to take part. If ‘NO’, 
please explain why not. 
 
Participants will be initially approached with support of GP practices and local social 
media pages for working age adults (18 yrs and above), given that chronic pain 
speciality in children and young adults is a specialty within itself.  

 
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Potential participants will have two weeks to contact the researchers for questions and 
to consider opting-in.  
 
Children 
Can you confirm that, where the participant is 16 years old or over, consent to 
participate in the research will be obtained from the young person themselves. 
 
   Yes        (but not applicable in this project)                 
   No 
 
Can you confirm that, where the participant is under 16 years of age but is judged to 
have the maturity and capacity to understand the nature of the research, consent to 
participate in the research will be obtained from the young person themselves. 
 
Not applicable.  
 
 
Please state the manner in which any apparent objection to participation by a 
minor will be handled. 
 
Not applicable. 
 
 
Please state whether and how parental consent, or consent of the legal guardian 
or order/declaration of the court, will be sought in relation to the participation of 
minors. 
 
Not applicable.  
 
NB. Copies of the consent form(s) and Participant Information Sheet(s) to be used in the research must 
accompany this application. 
 
 
5. How will participants who may not adequately understand verbal explanations or 
written information given in English be enabled to consent? 
 
Not applicable. Given the resource for this project, the potential confounding effects to 
the wider group and the manner in which groups are delivered, it will be a requirement 
for potentail participants to be able to understand verbal, written explanations and in 
English.  
 

 
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6. Please state what measures will be taken to ensure that participants are able to 
withdraw from the research at any time without explanation and without fear of 
reprisal should they so wish 
 
This will be included in the consent form.  
 
 
7. Confidentiality of data: 
 
What measures will be taken to protect the confidentiality of participants’ data? 
You should consider data in hard copy, electronic and audio/audio-visual form. You should 
explain how the anonymity of participants is protected during the data collection process, during 
data analysis and at the end of the research project.  
 
All participants will be allocated a participants number/code to protect their identity and 
databases will be anonymised, once paper/online survey data is submitted by the 
participant. The data will be anonymised before being shared with the university 
statistician.  
 
All data will be stored/shared within SOJ or appropriately encrypted USB storage 
devices and University 
 
Who will have control and act as custodian of the data used in / generated by the 
research? 
 
The lead researcher.  
 
Can you confirm that the data will be retained in accordance with the Data 
Protection (Jersey) Law 2005 which states that “data shall not be kept for longer 
than is necessary”? 
 
     Yes, I confirm that data, with regard to computer storage and processing of 
participants’ personal information, will be stored securely and confidentially for no 
longer than is necessary and comply with the Data Protections (Jersey) Law 2005. 
As far as possible, the data supplied and generated during the course of the study 
will remain confidential. 
 
 
8. Vulnerable groups: 

 
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Are you specifically recruiting participants from any of the following groups? 
 
Children under 16 
Pregnant women 
The elderly 
Persons suffering from mental disorder 
Adults with learning disabilities 
Prisoners 
Young offenders 
Other vulnerable groups 
 
 
 
 
 
 
 
 
 
Please explain why it is necessary to conduct research involving such 
participants, and whether the required data could be obtained by any other 
means. 
 
Not applicable 
 
Please state what special or additional arrangements, if any, will be applied, 
particularly in relation to Participant Information Sheets and gaining informed 
consent, to safeguard the interests of such participants. 
 
Not applicable 
 
Please state whether, and if so, how participation in the proposed research 
may/will be of personal benefit to individual participants. 
 
As above 
 
 
9. Disclosure statement: 
 
If you are working with vulnerable adults or minors (under the age of 18 years old), 
please state whether or not you have applied for and/or received a disclosure statement 
from the Criminal Records Bureau (CRB). 
 
   Yes                         
   No 
 
If ‘YES’, please give the disclosure number and date this was made. 
 

 
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Disclosure (certificate) 
number: 
Date of disclosure: 
 
14/08/2017 
 
 
 
Part 4: 
Financial and other arrangements 
 
1. Please state any financial or other interests (including any conflicts of interest) 
that the applicant, supervisor(s) or employer has in relation to the conduct of this 
research. 
 
The Lead Researcher is a Breathworks Accredited Mindfulness Teacher since 2013 and 
trainer since 2018. He is also an ACT practitioner and part of the Brewathworks Work 
Advisory Group (2018). However, given the project will evaluate the data utilsiing both 
Breathworks packages as active interventions, and with equal provision of both 
packages, there is not a direct preference for a given therapeutic approach. Breathworks 
have agreed to support financially the project and contribute to assessing the fidelity of 
the interventions provided. However, the analysis of data will be performed blind by Dr 
Ben Rosser at LJMU, in order to manage any potentail conflict.  There is no financial 
incentive or reward for the applicant, supervisor or employer in conducting this research.  
 
 
2. Please state the amount of payment, if any, that will be paid to the researcher(s) 
[over and above their normal salary]. 
 
None 
 
 
3. What additional costs will be incurred by HSSD through the conduct of the 
research, and how are these to be met? Please state the details of any funding 
which has been secured for the research. 
 
Currently Breathworks are considering the funding of two teachers to deliver the 
mindfulness interventions (flights, accommodation and subsistence), estimated to be in 
the region of £8000 plus £8160 in travel, accommodation and subsistence costs.  
 
We have also applied for in the region of £13000 to cover the qualitative analysis of the 

 
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data. Failing that, we will utilise trained volunteers and support from University (See 
Clulow application form).  
 
The pain clinic lead and project sponsor, Dr Chat Taylor, has agreed for the project to be 
part of the Pain Clinic research work that forms part of the lead researcher and assistant 
psychologist / research assistant remit, and therefore, as part of the job plan of both 
members of staff. It is also in line with the pain clinic strategy around contribution to 
teaching and training on self-managing pain in Jersey. We have however showed the 
monetary value of this contribution as part of any requests for support and grant 
requests.  
 
Dr Taylor has agreed to fund materials (books that are used as course manuals, 
stationery for psychometric and interview material, floor mats, refreshments and 
utilisation of group room within the premises outside of the times used by the clinics 
regular courses). The anticipated cost of books is in the region of £1000, mats & 
stationary £200 & refreshments £40 Total: £1240  
 
Stationary costs will be will be mitigated with the use of online survey tools where 
possible (surveymonkey).  
4. What arrangements are in place for monitoring the conduct of the research, and 
dealing with any issues, complaints or adverse effects which may arise from the 
research? 
[Note that, in the first instance, complaints should be addressed to the Academic Research 
Supervisor or the sponsoring Head of Department] 
 
The lead researcher will be the point of contact for any adverse effects (distressing 
thoughts or emotions) arising from the intervention. However, to mitigate this, no 
participant with current diagnosis of PTSD or active psychiatric condition requiring 
treatment, or drugs and alcohol dependence will be accepted on the trial (part of the 
exclusion criteria) as part of the recruitment process.  
 
 
 
 
 
 

 
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APPENDIX 
 
 
 
Appendix 1 
List of References 
 
Baer, R. A., Hopkins, J., Krietemeyer, J., Smith, G. T., & Toney, L. (2006). Using 
Self-Report Assessment Methods to Explore Facets of 
Mindfulness. Assessment, 13(1), 27-45. 
 
Bawa, F. L. M., Mercer, S. W., Atherton, R. J., Clague, F., Keen, A., Scott, N. W., & 
Bond, C. M. (2015). Does mindfulness improve outcomes in patients with 
chronic pain? Systematic review and meta-analysis. British Journal of General 
Practice, 65(635), e387-e400. doi:10.3399/bjgp15X685297 
 
Bond, F. W., Hayes, S. C., Baer, R. A., Carpenter, K. M., Guenole, N., Orcutt, H. K., . 
. . Zettle, R. D. (2011). Preliminary psychometric properties of the Acceptance 
and Action Questionnaire-II: a revised measure of psychological inflexibility 
and experiential avoidance. Behav Ther, 42(4), 676-688. 
doi:10.1016/j.beth.2011.03.007 
 
BPS. (2013). Guidelines for Pain Management Programmes in Adults. Retrieved from 
https://www.britishpainsociety.org/static/uploads/resources/files/pmp2013_mai
n_FINAL_v6.pdf 
 
Braun V. and Clarke V. (2006) Using thematic analysis in psychology. Qualitative 
research in Psychology; 3(2):77-101. 
 

 
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Brown, K. W., & Ryan, R. M. (2003). The benefits of being present: mindfulness and 
its role in psychological well-being. J Pers Soc Psychol, 84(4), 822-848.  
 
Burch, V. (2008). Living Well with Pain and Illness: Piatkus. 
 
Burch, V., & Penman, D. (2013). Mindfulness for Health: A practical guide to relieving 
pain, reducing stress and restoring wellbeing: Little, Brown Book Group. 
 
Day, M. A. (2017). Overview of the eight-session treatment. In Mindfulness-Based 
Cognitive Therapy for Chronic Pain: A Clinical Manual and Guide, (pp. 89-
113): John Wiley & Sons Ltd. 
 
Day, M. A., Jensen, M. P., Ehde, D. M., & Thorn, B. E. (2014). Toward a Theoretical 
Model for Mindfulness-Based Pain Management. Journal of Pain, 15(7), 691-
703. doi:10.1016/j.jpain.2014.03.003 
 
Dobkin, P. L. (2008). "Mindfulness-based stress reduction: What processes are at 
work? (Author abstract) (Report)." Complementary Therapies in Clinical 
Practice 14(1): 8. 
 
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Fish, R. A., B. McGuire, M. Hogan, T. G. Morrison and I. Stewart (2010). "Validation 
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Gillanders, D. T., Bolderston, H., Bond, F. W., Dempster, M., Flaxman, P. E., 
Campbell, L., . . . Remington, B. (2014). The Development and Initial 
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Harrison, A. M., Scott, W., Johns, L. C., Morris, E. M. J., & McCracken, L. M. (2017). 
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Hayes SC, Strosahl K, Wilson KG (1999): Acceptance & Commitment therapy: An 
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Hedges, L. (1981). Distribution Theory for Glass’s Estimator of Effect Size and 
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Hennessy, G. (2017). The Little Mindfulness Workbook: Everyday techniques to help 
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doi:10.1016/j.jcbs.2016.07.006 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix 2 CV 
 
 CV OF LEAD RESEARCHER: DR ALESSIO AGOSTINIS 
 
I obtained my first Bachelor of Sciences with Honours Degree, in Applied Psychology, from 
Liverpool John Moores University in 2002. I subsequently successfully completed a Doctoral 
Degree in Clinical Psychology from the University of Leeds in 2008. This is a highly 
competitive 3-year programme including academic, clinical and research components. It 
terminated with successful completion (and eventual publication in the scientific literature) of 
a Doctoral Thesis (The Role of Analgesia, Mood, Post-Traumatic Stress and Demographic 
Variables in Mimicking Post-Traumatic Amnesia).  I am a registered practitioner with the 
Health Professions Council (HPC reg. n PYL01708) and I have further achieved Associate 
Fellowship status with the British Psychological Society (BPS reg. n 096782), due to my 
length of membership and my service as an Executive Committee Member of the British 
Psychological Society (North East of England Branch) between 2006 and 2008.  I feature 
both on the Charter and the Expert Witnesses Directories of the Society and I am a member 
of the Division of Clinical Psychology within the Society. I am a UK listed mindfulness teacher 
and accredited Breathworks mindfulness teacher and associate mindfulness trainer.  
 
I have trained, practiced and continue to do so with adults presenting with a wide range of 
psychological difficulties, including anxiety, depression and Posttraumatic Stress Disorder 
(PTSD), as well as more complex presentations including physical and psychological co-
morbidities (chronic pain). I provide assessment, psychological therapeutic interventions, 
teaching and training to individuals, groups, health-insurance clients and various 
organisations. My therapy practice is informed by Cognitive Behavioural Therapy (CBT), as 
well as a mindfulness-based evolution of this called Acceptance and Commitment Therapy 
(ACT) and EMDR, a trauma-based adaptive information processing therapy. I have provided 
medico legal expertise in personal injury including the range of psychological conditions and 
persistent (chronic) pain, since 2009. I am employed full time by the States of Jersey as the 
only Clinical Psychologist specialising in Chronic Pain Management. In addition I am the only 
Psychologist in the Channel Islands working within a multidisciplinary intensive Pain 
Management Programme in line to the packages offered elsewhere in the UK. As part of 

 
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ensuring that my level of expertise remains current, I have regular formal supervisory contact 
with my counterparts managing the largest Pain Management Centres in the UK and regular 
mindfulness and therapy supervision.   
 
I further maintain my knowledge base and research skills by attending and submitting 
research data to National and International Conferences, which have included Montreal and 
Milan World Pain Congresses (2010, 2012), British Psychological society NEE Branch 
Conference (2013), States of Jersey Quality Improvement Awards on piloting and 
implementing mindfulness in the local pain service. (2016). I have been an Honorary 
Research Fellow of Liverpool John Moores University since December 2017. 
 
I am the founder and principal of Jersey-based CTT International, a business offering a 
mixture of bespoke psychological consultation, therapy and training, as well as formal 
diagnostic assessments and workplace reasonable adjustments of adult dyslexia. I am also 
the Managing Director of Jersey International Mindfulness Centre Limited (JsyIMC) a 
mindfulness specialist provider to corporates and high performance athletes both in Jersey 
and in the UK. 
 
A list of published conference posters, papers and presentations, as well as of delivered 
mindfulness workshops and teaching is available on request.  
BIOS for the current research and supporting team also include:  
 
Dr Chad Taylor (sponsor), Consultant in Pain Medicine with professional responsibility and 
interest in prescribing for Persistent Non-Malignant Pain (PNMP) including presenting at 
national pain conference (2013) on “Opioid Use, Risk Assessment Stratification and 
Management” 
 
Colin Duff  
(MSc Manchester University) has worked with Breathworks CIC since 2007, coming from a 
background in business and mindfulness teaching.  His role at Breathworks includes liaising 
with academic and health service partners in business and research projects, as well as 
working with clients from a wide range of backgrounds.   
 
Ben Rosser 

 
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Ben Rosser is a clinical psychologist working at Liverpool John Moores University as a senior 
lecturer/researcher. He also holds an honorary contract within the NHS, working clinically 
one day a week in a Clinical Health Psychology department. Ben Rosser has an interest in 
third-wave therapies and has used Acceptance and Commitment Therapy and mindfulness 
in his clinical practice. His research interests include transdiagnostic conceptions of 
psychological difficulties and he has recently published a systematic review on the topic of 
intolerance of uncertainty. Ben Rosser has completed both clinical (DClinPsy) and academic 
(PhD) doctorates. He completed his clinical training at the University of Exeter and PhD at 
the University of the West of England. His previous research experience was in chronic pain 
and telehealth at the University of Bath. His publication list includes a range of peer-reviewed 
research and reviews on these topics.  
 
Mr Jonathan Bond 
Jonathan has worked at the pain clinic as a voluntary assistant psychologist and research 
assistant and is currently employed as the team Assistant Psychologist. He is a psychology 
graduate with an aptitude for operational management who will support with the operational 
and data collection aspects of the project, under supervision of the project lead.   
 
Dr Nigel Minihane 
Nigel is the local Primary Care (GP) Body Lead and has numerous years experience on the 
strategic delivery of primary care, he still works as a GP and has been involved in supporting 
various projects in the past. He has kindly agreed to support us in the delivery of the current 
project and has been involved in a number of conferences and pain-related chronic patient 
initiatives in the past.  
 
 
 
 
 
 
 
 
 
 

 
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Appendix 3: Invite Letter/Advert text. 
 
Jersey Online Mindfulness for Pain 
Study 
Date 
 
 
««AddressBlock»» 
 
 
Dear  
 
Jersey Mindfulness for Pain Study – A Request for your involvement 
 
Do you have chronic pain? If so, this is an invite for you to take part in this important 
study into the effect of Mindfulness on persistent pain conditions by attending a free 
online mindfulness course.  Please find enclosed an information sheet outlining the 
purpose and benefits of the study.  This study is being undertaken through a 
collaboration between Jersey’s Pain Clinic, local GPs,  Breathworks CIC, a 
community interest company specialising in creating & providing mindfulness 
courses, and Liverpool John Moores University. 
 
The study is investigating if there is a difference between Pain and stress versions of 
mindfulness courses as a treatment for persistent pain.  The results will be used to  
improve the management of Persistent Pain conditions in Jersey. 
(Please contact us on 01534 444669 or a.agostinis@health.gov.je for further 
information and if you wish to consider signing up) 

 
HSSD Research Ethic’s Committee v2018  
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It is important that a large sample of the Island’s community of persistent pain 
sufferers take part in order to make the study valid.  All data from the study will be 
analysed anonymously and your name and address are included in the first 
instance only, to allow administration of the questionnaire and to send reminders.  
The identity of participants providing the questionnaire and interview data will 
be removed prior to analysis. 
 
The study has been scrutinised by the HCS Research Ethics Committee and granted 
a favourable ethical opinion.  It is envisaged that the findings will be of high relevance 
to patients, clinicians and the Island as a whole but also the wider clinical community.  
The results will be disseminated to you all as they become available.  
 
Thank you for taking the time to look at the enclosed information and deciding 
whether you wish to take part in the study.  
  
 
Yours faithfully 
 
 
 
Dr Alessio  Agostinis 
Consultant Clinical Psychologist in Pain 
Lead Researcher 
 
 
 
 
 
 
 
 
 
 

 
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Appendix 4. Participant Information sheet 
Online Mindfulness in chronic 
pain: Jersey Study 
Information Leaflet 
 
We are requesting your participation in a research study to explore how online 
mindfulness courses may influence your experience of pain and how you cope with it. 
You have been sent this information because you have been identified or self-
identified as currently suffering from a persistent (chronic) pain condition.  The 
research is led by a Pain Consultant Psychologist and the courses will be delivered 
by Breathworks CIC accredited mindfulness teachers. Breathworks are a UK 
Community Interest Company that has developed mindfulness courses for pain, 
stress and the workplace and they have included sufferers’ own experience of 
mindfulness in these. 
 
What is the purpose of the study? 
Persistent Pain (PP) is a very common problem which can be managed in a variety of 
ways.  This research will help us to better understand how different versions of 
mindfulness can help people with PP including pain itself, the interference caused by 
pain and the related emotional distress.  We hope to use the information provided to 
develop the island’s existing mindfulness provision in a way that is more targeted to 
people’s individual needs both in the community and in specialist pain management 
centres. 
 
What will the study mean for me? 

 
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If you agree to take part, you will be invited to attend an 8-week online mindfulness 
course (either a stress or a pain specific course) led by a qualified mindfulness 
practitioner for 2.5-3 hours once a week. You can attend using either your phone, 
laptop or tablet device using a free videoconferencing app. You’ll be also invited to 
practice in between sessions (approximately 20 minutes each day in your own time), 
including meditation, keeping a short diary of your practice (and duration) and to 
attend all sessions. You will be given a book and a CD of guided meditations. You 
will be asked to fill in a questionnaire once you are deemed suitable and placed on 
the waiting list for the course. Then again weekly for the duration of the course and 
one and three months after the course. You will be asked to do so via an online 
survey link or paper, which will take approximately 20 minutes each time to complete. 
At the end of the course you may be invited to give a short confidential interview 
about your experience of attending the course that will last around 30 minutes but 
only a proportion of participants who are willing will be invited to do this interview. 
The mindfulness courses will be video recorded. The follow-up interviews will be 
recorded for the purpose of transcribing the information for qualitative analysis and 
only seen by members of the research team for this purpose. 
 
All the data you provide us will be strictly confidential, it will be anonymised 
and the members of the research team analysing the data will be blind to the 
identity of individuals involved. The research will be run in conjunction with 
Liverpool John Moores University (statistician) and Breathworks CIC. 
 
How will my Information be Stored? 
We will use the information you provide in a manner that conforms to the Data 
Protection (Jersey) Law 2018. For further information about how data is used in the 
Pain Management Clinic, please see the Pain Management Clinic Privacy Notice. 
Should you wish to obtain a copy please contact the Pain MDT Coordinator on 
445609 
 
The protocol for the Mindfulness for Pain Jersey Study has been granted a 
favourable ethical opinion from the HCS Research Ethics Committee. 
 

 
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N.B. If you touch on any matter that raises a concern about the wellbeing or 
safeguarding of another person or yourself, we are duty bound to pass that 
information on to a relevant agency, which means we are unable to keep such 
information confidential. 
 
 
You are free to withdraw your participation from the study at any time, even 
after you have signed the consent form. You will be able to withdraw your data 
from the study only ahead of the data analyses. These are expected to take 
place at the end of the courses and six months later  when you complete the 
related end and follow-up questionnaire packs(for the main analysis) and 
within six months, for the recorded interview (if applicable to you). Should you 
wish to withdraw, the information you provided will be destroyed. 
 
Do I have to take part? 
Your involvement in the study is purely voluntary; you do not have to take part if you 
do not want to.  In order for the study to be valid, we will require the participation of a 
large number of participants and we would therefore be very grateful for your 
involvement.   
 
 
 
 
 
 
 
Are there any risks involved? 
Some studies have shown that meditation can cause increased distress in people 
with Post Traumatic Stress Disorder, or if there is current psychiatric difficulty. If you 
have this condition we do not recommend you taking part in this study. 
 
Will my taking part in this study be kept confidential? 
All the information you give us will be treated in the strictest confidence and used 
only for the purpose of this research study.  The consent form, with your name on it, 
will be removed from the questionnaire and the matched data sets will be 
anonymised prior to analysis.   
 
Who is organising and funding the research? 

 
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The Research Team consists of clinicians from HCS (Pain Management Centre), 
Jersey Primary Care (GPs) and the Breathworks CIC and Liverpool John Moores 
University.  The Jersey research team are completing the work within their usual job 
roles with no additional financial funding. The Breathworks Foundation are also 
providing funding for one of the teachers delivering the classes. 
 
Who has reviewed the study? 
The study has been scrutinised by the HCS Research Ethics Committee and granted 
a favourable ethical opinion.  It is envisaged that the findings will be of great 
relevance to all patients involved and the Island as a whole as well as the wider 
research community. 
  
What will happen to the results of the study? 
The results of the study will be used to develop training materials and resources prior 
to eventually being disseminated through publications and presentations at 
conferences.  At no time will the identity of the individual participants involved appear 
in this information.  A summary of the research will be printed and distributed to all 
involved parties. 
 
 
Thank you for taking the time to read this leaflet. 
If wish to have the opportunity to ask any question about the project, please call Dr 
Alessio Agostinis on 01534 444669 or one of our research team via our team co-
ordinator on 01534 445609. Alternatively, email Dr Agostinis on 
a.agostinis@health.gov.je with your questions or to arrange a suitable time to speak. 
 
 
 
 
 
 
 
 
 

 
HSSD Research Ethic’s Committee v2018  
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Appendix 5: Consent Form 
 
RESEARCH STUDY CONSENT FORM 
Research team: Dr Alessio Agostinis (Lead Researcher); Dr Chad Taylor (Sponsor), Dr Nigel 
Minihane (GP and Jersey Primary Care Body), Dr Ben Rosser (Liverpool John Moores 
University) Jonathan Bond (Pain Clinic), Colin Duff (Breathworks CIC). 
 
 
Please tick to confirm 
• 
I have read the information sheet for the above research study 
 
□ 
• 
I have been offered the opportunity to ask questions about the research study via the 
contact details provided on the research information leaflet . I have either not needed 
to ask further questions, or I have made contact and asked questions at the time of 
completing this consent form  
 
 
 
 
 
□ 
• 
I understand the purpose of the research study and how I will be involved □ 
• 
I understand that all information collected in the research study will be  
held in confidence and that if it is presented or published, all my personal 
details will be removed 
 
 
 
 
 
 
□ 
• 
I confirm that I will be taking part in this research study of my own free will,  
and I understand that I may withdraw from it as for the terms stated in the Participant  
Information Sheet, without my normal care being affected  
 
□ 
• 
I understand that if I touch on any matter that raises a concern about the wellbeing or 
safeguarding of another person or myself, you are duty bound to pass that 
information on to a relevant agency, which means you are unable to keep such 
information confidential. 
 
 
 
 
 
 
□ 
• 
I understand the requirement for and consent to my GP and/or healthcare records to 
be checked for the purpose of my suitability to take part in this study.  
 
 
 
□ 
• 
I confirm I am 18 years of age or older 
  
 
 
 
□ 
 
I agree to take part in the above research study. 
 
Signed: ………………………………….. 
 
Date: ……………………… 
 
Print name:……………………………….  
 

 
HSSD Research Ethic’s Committee v2018  
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Please complete this consent form.  If you have any questions about this form or 
outstanding questions about the study, please call Dr Alessio Agostinis on 01534 
444669 or one of our research team via our team co-ordinator on 01534 445609. 
Alternatively, email Dr Agostinis on a.agostinis@health.gov.je with your questions or 
to arrange a suitable time to speak 
Thank you for taking the time to fill in this consent form, 
your answers will be very useful to the Research Team. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix 6: Consent Form 
 
RESEARCH STUDY COURSE PROVIDER CONSENT FORM 
Research team: Dr Alessio Agostinis (Lead Researcher); Dr Chad Taylor (Sponsor), Dr Nigel 
Minihane (GP and Jersey Primary Care Body), Dr Ben Rosser (Liverpool John Moores 
University) Jonathan Bond (Pain Clinic), Colin Duff (Breathworks CIC). 
 
 
Please tick to confirm 
• 
I have had the opportunity to ask questions about my role as a mindfulness course 
teacher in the research study directly with a member of the Research team via 
telephone, email or face to face 
 
 
 
 
 
□ 
• 
I understand the purpose of the research study and how I will be involved □ 
• 
I understand that all information collected in the research study will be  
held in confidence and that if it is presented or published, all my personal 
details will be removed 
 
 
 
 
 
 
□ 
• 
I understand that if I touch on any matter that raises a concern about the wellbeing or 
safeguarding of another person or me, you are duty bound to pass that information on 
to a relevant agency, which means you are unable to keep such information 
confidential. 
 
 
 
 
 
 
 
 
□ 
• 
I understand that for the purposes of evaluating the fidelity to the Breathworks 
Mindfulness for Stress or Mindfulness for Health teachers’ notes and protocols, I am 
required and consent to being recorded delivering the mindfulness courses 
 
 
 
 
 
 
 
 
□ 
• 
I understand that the audio-visual recording of the classes will be evaluated (and 
scored) by two separate assessors and stored in accordance with relevant data 
protection and research ethical guidelines.  
 
 
 
 
□ 
 
I agree to take part in the above research study. 
 
Signed: ………………………………….. 
 
Date: ……………………… 
 
Print name:……………………………….  
 

 
HSSD Research Ethic’s Committee v2018  
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Please complete this consent form.  If you have any questions about this form or 
outstanding questions about the study, please call Dr Alessio Agostinis on 01534 
444669 or one of our research team via our team co-ordinator on 01534 445609. 
Alternatively, email Dr Agostinis on a.agostinis@health.gov.je with your questions or 
to arrange a suitable time to speak 
Thank you for taking the time to fill in this consent form, 
your answers will be very useful to the Research Team. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix 7: Risk Assessment Form 
 
Jersey Mindfulness Project – 
Risk Assessment 
 
 
Identified Risks 
Likelihood Potential 
Impact/Outcome 
Risk Management/Mitigating 
Factors 
 
 
 
Practicing 
mindfulness 
meditation has 
been known to 
trigger distressing 
memories in 
patients with 
existing 
Trauma/PTSD 
 
 
 
 
 
Low 
 
 
 
Participant: 
• Psychological 
Stress 
 
Researcher 
• Anxiety about 
dealing with a 
complex 
situation 
• Exclusion criteria for 
enrolling in the study will 
include those with pre-
existing psychiatric 
comorbidities, 
particularly 
Trauma/PTSD 
conditions 
• As we are recruiting 
from primary care GPs 
will be informed of this 
criteria as will patients 
themselves in their 
information packs 
• The researcher will be 
able to signpost 
participant to the 
relevant support 
services 
 
Discussion of 
sensitive topics in 
interview has 
 
 
Low 
Participant: 
• Psychological 
Stress 
 
• Offer to cease interview 
• Exclusion criteria (as 
above) 

 
HSSD Research Ethic’s Committee v2018  
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potential to cause 
distress to 
participant 
 
Researcher 
• Anxiety about 
dealing with a 
complex 
situation 
• The researcher will be 
able to signpost 
participant to the 
relevant support 
services 
 
 
Conflict between 
participants in 
group setting 
 
 
Low 
Participant: 
• Psychological 
Stress 
 
Researcher 
• Anxiety about 
dealing with a 
complex 
situation 
 
• The researcher will 
have the necessary 
training and experience 
in group facilitation to 
handle conflicts 
 
 
 
Data collection & 
interviews may 
possibly take place 
in an unfamiliar 
location with 
people not already 
known to the 
researcher 
 
 
 
 
High 
 
 
 
Researcher 
• Physical Injury 
or 
Psychological 
Harm 
• Visit location prior to 
data collection to 
assess possible risks 
associated with built 
and social environment 
• Use this information to 
plan session 
• Identify back up at 
location or online 
preferably 
• Allow extra time to 
familiarise participants 
with research and 
environment 
• Researcher to have 
contact details and 
means of making timely 
contact with back up 

 
HSSD Research Ethic’s Committee v2018  
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Disclosure of 
information about 
poor practice 
 
 
Low 
 
Immediate, urgent or 
prompt response 
may be required from 
service providers 
• Ensure all verbal and 
written information 
about research 
indicates possible 
researcher response to 
disclosure 
• The researcher will be 
able to signpost 
participant to the 
relevant support 
services 
 
Disclosure of 
unmet health or 
social care needs 
 
 
Medium 
 
Immediate, urgent or 
prompt response 
may be required from 
service providers 
• Ensure all verbal and 
written information 
about research 
indicates possible 
researcher response to 
disclosure 
• The researcher will be 
able to signpost 
participant to the 
relevant support 
services 
 
 
Research 
participant in 
danger of harm to 
self or others 
 
 
Low 
 
Immediate, urgent or 
prompt response 
may be required from 
service providers 
• Ensure all verbal and 
written information 
about research 
indicates possible 
researcher response to 
disclosure 
• The researcher will be 
able to signpost 
participant to the 

 
HSSD Research Ethic’s Committee v2018  
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relevant support 
services 
 
 
 
Notes to Applicants  
 
1. 
The Research Ethics Committee requests that all applicants complete the standard 
application form in a word processed form.  Please note, incomplete forms may result in 
undue delay in considering your proposal. Applications which are not complete or have 
missing supplementary documentation will not be passed to the Research Ethics Committee 
and may be returned. 
 
2. 
The application form is designed to summarise the information concerning your proposed 
research in order for the Research Ethics Committee to make an assessment.  Please 
ensure that all sections are completed. (See the checklist page 2 of the application form).  All 
relevant supplementary documentation must be included with your completed application 
form. 
 
3. 
Please avoid the use of abbreviations and jargon wherever possible and provide a clear 
explanation of technical terms used for the benefit of lay committee members. 
 
4. 
The application form is intended to be largely self-explanatory.  However, the following 
comments may assist in completion of this: 
 
 
Part 1 – Applicant details 
 
 
Full details should be given of applicant who is proposing to conduct the research project.  
This must be signed by an academic or clinical supervisor (depending on who is sponsoring 
and who is supporting the research). 
 
 
Part 2 – Introduction  
 
 
Full details should be given of the research team who will be involved in carrying out the 
research project. If there is only one researcher/investigator he/she will be the Lead 
Researcher/Principal Investigator for the purposes of the form.  

 
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The sponsoring body must be identified. Researchers should carry personal insurance and/or 
be covered by insurance, or provision made by the employer.   
 
Research sponsored by a pharmaceutical company requires adherence to Association of the 
British Pharmaceutical Industry Guidelines. 
 
Research undertaken as part of an academic programme of study must have university 
sponsorship. 
 
 
Part 3 – The Research 
  
 
Section 2 Outline of research 
It is important that the committee is made aware of the status and type of participant to be 
recruited and the criteria for inclusion and exclusion of individuals.  Please note that in the 
case of clinical trials, the relative level of acceptable risk may be greater in therapeutic 
research in patient volunteers (where there is a balancing factor of potential benefit) than in 
non-therapeutic research using "healthy volunteers". 
 
You must state whether participants will be selected with specific reference to sex, age group 
and status.  You should make clear what proportion of participants recruited (if any) will act 
as controls. 
 
The effectiveness and propriety of recruitment and selection procedures must be clear. 
Participants must not be coerced or induced to participate. 
 
Any conflict of interest must be declared, particularly in cases where a participant's 
relationship with the researcher could raise issues as to the willingness or motive of the 
participant in consenting to participation (e.g. students). 
 
 
 
Section 3 Ethical issues  
 
In discussing the potential risks and hazards which are associated with the research, 
applicants are required to specify the degree of probability (e.g. percentage terms or as 
unlikely, possible, likely, expected) and to categorise the risk (e.g. serious, moderate, minor, 
negligible or in percentage terms).  The committee is concerned about the possibility and 

 
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nature of anticipated side effects and the nature and extent of the risks that the participant 
assumes to physical or mental health and well-being by participation. 
 
 
Section 4 Informed consent  
Informed consent is a requirement from all research participants.  Where problems may be 
encountered as a result of language or hearing difficulties, the applicant must explain how 
these difficulties are to be handled - e.g. interpreter, translation of documents 
 
In any circumstances where the investigator does not anticipate being in a position to obtain 
participant consent (e.g. studies involving emergency patients, the unconscious, children 
under 16 who are not judged competent by the investigator to consent in their own right etc.) 
the applicant must provide full details of the course proposed to be taken with regard to 
consent and the justification for it.  The answer must address the patient's best interests: i.e. 
will or could enrolment into the research be of therapeutic value to the individual.   
 
Participant information sheets and consent forms must be prepared and presented as 
separate documents or as an appendix to the application.   
 
In respect of clinical trial research, the participant’s GP should be notified before the research 
commences.  Participant consent to such notification (and to further related communication 
with the GP if necessary) should therefore generally be incorporated into the consent form 
(and notice of this requirement added to the information sheet).  If you do not intend to 
contact participants' GPs, please give reasons. 
 
Section 8 Vulnerable groups 
The need to conduct research in "special" or "vulnerable" groups as listed on the application 
form should be justified. Clarification that the data required could not be obtained from any 
other class of participant is required.  The needs of special groups may indicate extra 
safeguards/procedures in relation to the provision of information and consent procedures.   
 
Part 4 – Financial and other arrangements 
 
A full statement should be included of all payments, funding and grants which may be made 
to, or have been agreed with the applicant, his department or employer in connection with the 
performance of the research.  "Payment" includes donations of equipment or other 

 
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appliances. (Such financial support should be related to expenses, costs incurred and 
resources expended in the conduct of the research). 
 

 
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Documents which must accompany the application for ethical opinion of proposed 
research, where relevant: 
 
(i) 
Recruitment advertisement(s) if applicable and any other material proposed to be 
used for recruitment. 
 
(ii) 
GP letter, if applicable 
 
(iii) 
Patient information sheet (and letter of invitation, if applicable). 
 
(iv) 
Consent form. 
 
(v) 
Research protocol (research summary).  
 
(vi) 
Where applicable, a copy of regulatory approval in the form of any product licence, 
Clinical Trial Certificate (CTC), Clinical Trial Exemption (CTX), Doctor’s and Dentist’s 
Exemption (DDX) or other authority in writing i.e. proof of regulatory compliance (not 
applicable in healthy volunteer studies).  Please note that the authority may not 
extend to Jersey and, in such circumstances, further approval will need to be 
sought locally. 
 
(vii) Data sheet if licensed product(s) are being used in clinical trial research. 
 
(viii) Administration of Radioactive Substances Advisory Committee (ARSAC) approval, 
where appropriate. 
 
(ix) 
Where applicable, company confirmation of adherence to relevant Association of the 
British Pharmaceutical Industry (ABPI) Guidelines. 
 
(x) 
Risk assessment in compliance with the States of Jersey Health and Social 
Services, Health and Safety Policy requirements. 
 
(xi) 
Full MREC application or university REC application if applicable. 
 
(xii) Confirmation of favourable opinion from university faculty REC, if applicable. This 
may be forwarded after the application.