A feasibility study on integrating home-based metacognitive therapy for anxiety and depression in the cardiac rehabilitation pathway (PATHWAY STUDY 3)

You are being invited to take part in a research study. Before you decide whether or not you would like to take part in the study, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss with others if you wish.

  • Part 1 tells you the purpose of the study and what will happen if you take part.
  • Part 2 gives you more detailed information about the process of the study.  

Please do not hesitate to ask us if there is anything that is unclear or if you would like more information.

Version 4 – DATE: 07.06.2017

Part 1

1.1    What is the purpose of the study?

You will be involved in a research study to assess a new way of helping people with anxiety and low mood. When we want to introduce a new way to treat people, it is important that we compare the new way against our usual way of working and measure the results to see which way of treating people is best. In this study we would like to find out if it might be helpful for people experiencing distress following a cardiac event to undertake a home-based psychological intervention alongside their usual cardiac rehabilitation. The new way to treat patients is called home-based metacognitive therapy (Home-MCT). The findings will help us to identify how well home-based metacognitive therapy might work and to calculate its costs. Findings will help us to know if the new treatment is acceptable and identify any challenges/difficulties. Findings from this study will help us to make changes before we carry out a larger study. We need to ensure that research meets patients needs and that’s why we would like to invite you to take part.  

1.2    What is the therapy?

 Home-based Metacognitive Therapy

 Metacognitive therapy is a psychological therapy that helps people to manage worries, low mood and distressing thoughts and feelings. This therapy helps people to discover new and more helpful ways to react to negative or distressing thoughts, so that they are less likely to dwell on them, with a positive effect on anxiety and mood. This study assesses a home-based format of metacognitive therapy. Participating in the study will not affect your current or future healthcare.

1.3    Why have I been invited?

You have been invited to take part in this study because you have been referred to the cardiac rehabilitation pathway and have indicated that you might be experiencing some distress/difficulties.

1.4    Do I have to take part?

No – it is your decision entirely and taking part is voluntary. If you do decide to take part, you will be given this information sheet to keep and will be asked to sign a consent form which acknowledges you have fully understood what you are taking part in. If you do consent but later on you do not want to carry on with the study, you are still free to withdraw from the study at any time. You do not need to give a reason. Withdrawing from the study will not affect your current or future healthcare.

1.5       What will happen if I take part? 

As mentioned previously, we would like to compare home-based metacognitive therapy (Home-MCT) to usual care and measure the results to see which way of treating people is best. To do this, we will be allocating people into one of these two groups:

  • Group 1: Your usual care along the cardiac rehabilitation pathway with NO home-based metacognitive therapy.
  • Group 2: Your usual care along the cardiac rehabilitation pathway PLUS home-based metacognitive therapy.

To make sure the allocation into one of these two groups is completed in a fair and unbiased manner, each participant is allocated into a group by chance (randomly). This process is called randomisation and it will be carried out by an independent service (i.e. the Centre for Biostatistics at the University of Manchester) using a computer programme. Random allocation is similar to the 50/50 chance of getting heads vs. tails when a coin is tossed. So, we will not be able to tell you which group you are likely to be assigned to before you agree to take part.

1.6         What will happen if I am allocated to Group 1?

-You will be asked to complete some questionnaires (e.g. demographic, distress, quality of life) which will take about 35 to 45 minutes. These questionnaires will be completed three times: at the beginning of the study, and after 4 and 12 months.

1.7         What will happen if I am allocated to Group 2?

-You will be asked to complete some questionnaires (e.g. demographic, distress, quality of life) which will take about 35 to 45 minutes. These questionnaires will be completed three times: at the beginning of the study, and after 4 and 12 months.

-You will receive a Home-MCT booklet, which you will be required to work through at your own pace. In addition, you will have an initial appointment with a Home-MCT trained CR member and will receive two supportive therapy telephone calls that will last up to 30 minutes each. These telephone calls will be audio-recorded if you agree. The estimated time to complete the Home-MCT booklet is approximately 6 weeks.

1.8          What about confidentiality?   

Relevant sections of your medical notes and data collected during the study may be looked at by individuals from the University of Manchester, Greater Manchester Mental Health (GMMH), and relevant staff at the hospital where you are receiving cardiac treatment where it is relevant to your taking part in this research. Questionnaire data will be pseudo-anonymised (i.e coded) using an ID number. If you consent, your name and date of birth will be sent to NHS digital. NHS digital will provide information about significant medical events to the research team. All data we obtain will be securely stored for 15 years in accordance with NHS policy.

All information collected during this study will be kept confidential in accordance with NHS Data Protection guidelines. Identifying information will be anonymised. Confidentiality will only be breached if you disclose to us information which may indicate harm to yourself or others. We will take every opportunity to discuss any possible breaches of confidentiality with you prior to informing any appropriate agencies (e.g., cardiac service staff, GP or A&E services).

1.9         What are the possible risks of taking part?     

It is possible that answering the questionnaires and/or talking about your difficulties may cause some distress. However, the Home-MCT booklet is designed to aid you in managing your negative feelings and thoughts more effectively.

It is important to understand that only half of the patients recruited to this study will receive Home-MCT. The other half will receive care along the cardiac rehabilitation pathway as usual. This will be allocated completely by chance, and therefore we are unable to tell you which group you will be allocated to prior to you agreeing to take part.

1.10       What are the possible benefits of taking part?

The information we gather from this study will help to inform care on the cardiac rehabilitation pathway for future patients and will provide details to develop further research on home based psychological interventions in cardiac patients. Home-MCT is designed to aid you in managing distress so you may benefit from receiving this therapy.

1.11       Are you participating in any other research?

Please inform the researchers and cardiac staff if you are currently participating in any other research so this can be discussed further.

1.12       What if there is a problem?

Any complaint about the way you have been dealt with during this study or any possible harm you might suffer will be addressed. Further information on this is given in part 2.

Thank you for reading Part 1 of this Information Sheet. If the information in Part 1 has interested you and you are considering participation, please continue to read the additional information in Part 2 before making any decision.

Part 2

2.1       What will happen if I don’t want to carry on with the study?

You are free to withdraw from the study at any point. In the event that you withdraw from the study all data obtained up until the point of withdrawal will be kept and analysed. However, all information we have collected from you can be destroyed if you wish by contacting a member of the research team. If you withdraw from the study, it will not affect your usual care in any way.

 2.2       What if there is a problem or I have a complaint about the study?

If you have a concern about any aspect of this study, you should speak to the researchers who will do their best to answer your questions (see contact details below, question 2.8). If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure. Details of this procedure can be obtained from Aintree University Hospital NHS Foundation Trust/Royal Bolton Hospital NHS Foundation Trust. 

This study is covered by the NHS indemnity for harm due to negligence and non-negligence. In the event that something goes wrong and you are harmed during the study then you may have grounds for legal action against the NHS, but you may have to pay your legal costs. The normal NHS complaints mechanism is also available to you.

2.3       Will I be compensated for my participation in the study?

You will receive a £5 voucher for completing the questionnaires the first time, a £10 for completing the questionnaires at 6 months and a £10 voucher for completing the questionnaires at 12 months.

2.4       How will the data collected about me be stored and used?

All data collected for this study will be kept safely and securely on computer and on paper records for 15 years in accordance with NHS policy. Clinical notes will be kept in your patient file at Aintree University Hospital NHS Foundation Trust/Royal Bolton Hospital NHS Foundation Trust in accordance with NHS policy. Professor Adrian Wells, who is the Chief Investigator for this study, will be the custodian of all study data. All details that could identify you will be removed before these are analysed by the study team.

The results will be published in reports and scientific journals, but it will not be possible to identify any individuals from these reports. The study team will send you a summary of the results at the end of the study if you would like one.

2.5       Who is organising and funding the study?

The study is funded by a National Institute for Health Research programme grant. Greater Manchester Mental Health NHS Foundation Trust are sponsoring and organising the study.

2.6       Who has reviewed the study?

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee to protect your safety, rights, wellbeing and dignity. This study was reviewed and given a favourable ethical opinion for conduct in the NHS by the Greater Manchester West Research Ethics Committee (Reference Number: 16/NW/0786). The study has also been reviewed by experts in the field of heart disease and psychology.

2.7       Would you like to take part in an interview?

If you are interested in taking part in the study, you will also be asked whether you would like to participate in interviews. The aim of the interviews is to know about your experiences as a cardiac rehabilitation pathway patient, the care you have received so far, how you felt about being offered the home-based therapy and the chance to participate in this research study. If you agreed to be contacted, a member of the research team may contact you to provide more information. There is no obligation to take part in interviews and if you choose not to do so this will not affect your participation in the rest of the study.

2.8       Who can I contact for further information?

PATHWAY TEAM Telephone: 0161 276 5326; Email: wendy.clarke@manchester.ac.uk; Address: Greater Manchester Mental Health NHS Foundation Trust, Rawnsley Building, 2nd floor, Manchester Royal Infirmary, Oxford Road, Manchester M13 9WL.

Professor Adrian Wells, Chief Investigator, Email: adrian.wells@manchester.ac.uk; Address: Greater Manchester Mental Health NHS Foundation Trust, Rawnsley Building, 2nd floor, Manchester Royal Infirmary, Oxford Road, Manchester, M13 9WL.

You can also contact your local Patient Advice and Liaison Service (PALS) on 0161 918 4047 to obtain independent advice about taking part in research.