Call for participants: Research Study on Method of Levels (MOL) Therapy For People Living with Psychosis In The Community

0
93

Is Method of Levels (MOL) Therapy An Acceptable And Feasible Online Psychological Intervention For People Living with Psychosis In The Community?

Please contact [email protected]manchester.ac.uk if you have any questions, or to express an interest in participating in the study.

Participant Information Sheet (PIS)

You are being invited to take part in a research study to explore what people experiencing symptoms of psychosis whilst living in the community think of Method of Levels as an online psychological therapy.  The research study will contribute to the completion of a post-graduate doctoral degree. Before you decide whether to take part, it is important for you to understand why the research is being conducted and what it will involve. Please take time to read the following information carefully before deciding whether to take part and discuss it with others if you wish. Please ask if there is anything that is not clear or if you would like more information. Thank you for taking the time to read this.

About the research

  • Who will conduct the research?

This research will be carried out by Phil Docherty who is a Trainee Clinical Psychologist as part of his training on the Clinical Psychology Doctorate programme (ClinPsyD) in the Division Psychology and Mental Health, School of Health Sciences, at the University of Manchester. The research is supervised by two qualified Clinical Psychologists; Dr Sara Tai and Prof Timothy Carey. This research is sponsored by the University of Manchester.

  • What is the purpose of the research?

People living with symptoms of psychosis often experience a variety of difficulties but may not meet the criteria to access psychological therapy, and when they do, they often must commit to attending 16 sessions of therapy. People tell us that therapy does not always really deal with the distress and real problems they face. Other options for delivering therapy that address patients’ individual needs must be explored.

This research study is about exploring what people think of a flexible form of online therapy aimed at addressing the specific needs that people have.  Only a fairly small number of people are needed to take part to do a ‘proof of concept’ study.

You have been invited to participate because you have self-reported experiencing one or more symptoms of psychosis.  We hope to recruit approximately 12 to 15 people to take part in this study.

  • Will the outcomes of the research be published?

The data will be analysed by the chief investigator as part of their doctoral thesis, under the supervision of qualified Clinical Psychologists. The findings will be written up for publication and hopefully published in a scientific journal and presented at conferences. All information will remain anonymous and it will not be possible to identify you in any reports or publications.

If you wish to receive a summary of the results once they are available, you can provide an email address that will allow us to contact you when the results are ready. This personal information will be kept separate from your questionnaire data and stored on secure servers at the University of Manchester.

The data collected in this study may be used to support future research. For example, the anonymous data files may be used in future studies or shared with researchers working on other studies. Any data used in the future will not contain your name or any other information that could identify you.

  • Who has reviewed the research project?

This study has been reviewed by Manchester University Research Ethics Committee.

Who is funding the research project?

This study is funded by the University of Manchester and the key research staff working on the project are employed by the University and/or the NHS.

What would my involvement be?

  • Do I have to take part?

No, your participation is completely voluntary, and it is entirely your decision whether or not you take part. If you do decide to participate, as well as receiving a copy of this information sheet to keep, you will be asked to complete an online consent form.  However, you can withdraw from the study at any time by telling the researcher that you no longer wish to continue. No questions will be asked about your decision and there will be no consequences to your current or future treatment. You can also request for your data to be withdrawn from the study up until the point when it is analysed.

  • What will happen if I agree to take part?

You will be invited to meet the researcher, online via a secure video link, who will answer any questions you have and explain how the therapy sessions work.  You will be emailed a secure link which will take you to a consent form and some questionnaires to complete.  The main part of the study will involve you booking your own therapy sessions using an online timetable of available therapy slots, which you can access via another secure link which will be emailed to you.  You can choose if, and when, you would like a session, and how long you would like each session to last (up to one hour each).  There are no set number of sessions that you have to attend, and you can talk about any issues that you think are affecting you. After agreeing to take part and completing the first set of online questionnaires you will be asked to complete the questionnaires every two weeks that you remain in therapy and again after each therapy session. You will also be asked to complete the questionnaires one month after your last therapy session. The questionnaires should take no longer than 30 minutes to complete. Once you decide you no longer want to have therapy sessions, or when the therapy part of the study in complete; whichever is soonest, you will be contacted for a short telephone interview about your experience of therapy.

  • What will Method of Levels therapy be like?

The researcher delivering therapy will be based in a private room and you will be asked to ensure that you also have privacy so that you can feel comfortable to talk.  Each time you meet the therapist online, they will ask you to choose what you want to talk about; usually something that is bothering you.  The therapist will help you to focus on the problem and talk about it. The therapists will ask you questions to help you think about things in different ways. There is no right or wrong way of answering because the aim is for the therapist to help you think about things in ways you might not have done so before. You will not be asked to do anything outside of the therapy sessions and you do not have to talk about the same problem if you have more than one session.  The sessions are completely voluntary, so it is entirely up to you to choose whether or not you want to have a therapy session.

Therapy sessions will be audio recorded.  Recordings will be played to the researcher’s supervisor at The University of Manchester to help ensure that the researcher is doing the therapy in the best way possible.  Audio recording of therapy sessions will be destroyed once they are no longer needed for supervision.

  • What will the questionnaires ask me about?

First you will be asked to provide information about yourself, including your age, gender, ethnicity, employment status, marital status, housing and any previous experiences of mental health difficulties you might have had. You will also be asked to complete a total of five questionnaires asking about your experience of the therapy, your perception of your own ability to function each day, any symptoms of psychosis you are experiencing, whether these are causing you distress and the degree to which you think you are able to manage all the different important life goals you have. If there are any questions you do not feel comfortable answering you can leave them unanswered.

  • Will I be compensated for taking part?

You will not receive any payment for taking part in therapy.  However, you will be compensated with a £10 high-street voucher for completing the follow up questionnaires.  The follow up session will be one after therapy is completed.

  • What happens if I do not want to take part or if I change my mind?

It is up to you to decide whether or not to take part.  If you do decide to take part you will be sent this information sheet to keep and will be asked to complete an online consent form and questionnaires. If you decide to take part you are still free to withdraw at any time without giving a reason and without detriment to yourself. However, it will not be possible to remove your data from the project once it has been analysed. This does not affect your data protection rights. If you decide not to take part you do not need to do anything further.

All therapy sessions will be audio recorded and reviewed in the researcher’s supervision to ensure adherence to the therapy model.  It is important that you are always comfortable with the recording process and understand that you are free to ask to stop recording at any time.

Data Protection and Confidentiality

  • What information will you collect about me?

In order to participate in this research project we will need to collect information that could identify you, called “personal identifiable information”. Specifically we will need to collect:

  • Age
  • Gender
  • Ethnicity
  • Marital status
  • Employment status
  • Housing status
  • Details of any previous mental health difficulties

Audio recordings will be made by the researcher in a private room during therapy sessions and will only contain the voices of you and the researcher.

  • Under what legal basis are you collecting this information?

We are collecting and storing this personal identifiable information in accordance with data protection law which protect your rights.  These state that we must have a legal basis (specific reason) for collecting your data. For this study, the specific reason is that it is “a public interest task” and “a process necessary for research purposes”.

  • What are my rights in relation to the information you will collect about me?

You have a number of rights under data protection law regarding your personal information. For example you can request a copy of the information we hold about you, including audio recordings.

If you would like to know more about your different rights or the way we use your personal information to ensure we follow the law, please consult our Privacy Notice for Research.  This document can be found at http://documents.manchester.ac.uk/display.aspx?DocID=37095

  • Will my participation in the study be confidential and my personal identifiable information be protected?

In accordance with data protection law, The University of Manchester is the Data Controller for this project.  This means that we are responsible for making sure your personal information is kept secure, confidential and used only in the way you have been told it will be used. All researchers are trained with this in mind, and your data will be looked after in the following way:

Only the study team at The University of Manchester will have access to your personal information, but they will anonymise it as soon as possible. Your name and any other identifying information will be removed and replaced with a random ID number. Only the research team will have access to the key that links this ID number to your personal information. Your personal details will be stored separately to your questionnaire answers and all information collected as part of the study will be on password protected files/computers at the University of Manchester.  Therapy sessions will be audio recorded using an encrypted recording device and then stored on password protected files/computers at the University of Manchester and destroyed once no longer required for supervision purposes.  Your personal details will not be on the recordings so your identify remains anonymous.

Records will be destroyed at the end of the study. Data from the study will be kept for a minimum of 5 years after the date of any publications in keeping with good practice guidelines for research.

We will ask for you to provide consent at the start of the study for us to write to your GP to say that you are taking part.  We will write to them again to inform them when you have completed the study.

Any information you give to the researcher will not be shared outside of the research team without your consent unless you give information about either yourself or others being at risk of being harmed.  If you do disclose information that means your safety or the safety of others might be at risk, or information about any current or future illegal activities, we have a legal obligation to share this information. In such cases, we might need to inform relevant professionals which may include your care team, your GP, social services, or the police or ambulance service. If the researcher does have to share information, they will discuss it with you first where possible.

Audio recordings:

  • All therapy sessions will be recorded. 20% of the therapy sessions recorded will be reviewed in supervision between the therapist and their academic supervisor, to ensure that the therapist is adhering to the therapy model.All therapy session recordings will be destroyed once no longer required for supervision.
  • Recordings of the final interview at the end of therapy will be recorded using encrypted devices and used to create transcripts by a member of the research team.
  • Final transcripts will not contain and personal identifying details.
  • Interview recordings will be stored electronically on secure servers specifically allocated to confidential research data storage at the University of Manchester and destroyed after 5 years.

Please also note that individuals from The University of Manchester or regulatory authorities may need to look at the data collected for this study to make sure the project is being carried out as planned. This may involve looking at identifiable data.  All individuals involved in auditing and monitoring the study will have a strict duty of confidentiality to you as a research participant.

Will anyone know that I am taking part?

We will inform your GP that you are taking part in a research study. However, they will not be told about the answers that you give to the questionnaires.  Details of what is discussed in therapy sessions will only be available to the research team unless the researcher is concerned about your or others’ safety, as explained earlier. This is to ensure everyone is kept safe and well.

When you agree to take part in a research study, the information about you may be provided to researchers running other research studies in this organization.  The future research will be of a similar nature to this research project and will concern psychological therapies.  You information will only be used by this organization and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research – Health Research Authority, which can be found at https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/.

This information will not identify you and will not be combined with other information in a way that could identify you.  The information will only be used for the purposes of analyzing the outcomes of therapy and cannot be used to contact you regarding any other matter.  It will not be used to make decisions about future services available to you.

What are the good things about taking part?

You will have the opportunity to have psychological therapy online while for the duration of the therapy part of the study and talk about problems you are having, in a private environment.  It will be your choice whether you want to have a therapy session, and how many you have.  Method of Levels (MOL) has shown to be helpful for people experiencing a range of problems.  Any care you receive normally will be unaffected by taking part in the study.

Are there any disadvantages or risks of taking part?

Talking about your problems can cause people to experience some discomfort or distress, although the aim is to help people to reduce distress that they are already experiencing. During therapy, the therapist will ask you to focus on a problem and think about it from different perspectives. Whilst people say this can be helpful, it might also feel challenging. Often, we want to try and avoid thinking about our problems and so focusing on them can feel stressful. Your therapist is there to support you with this, and you do not have to talk about anything you do not want to talk about. You are free to have a break or end therapy sessions at any time should you feel upset or distressed. If there are any questions you do not wish to answer you do not have to answer them.

What if I have a complaint?

  • Contact details for complaints

If you have a complaint that you wish to direct to members of the research team, please contact:

Dr Sara Tai

Consultant Clinical Psychologist

[email protected]

Tel: +44 (0) 161 275 2595

 

If you wish to make a formal complaint to someone independent of the research team or if you are not satisfied with the response you have gained from the researchers in the first instance then please contact

The Research Governance and Integrity Officer, Research Office, Christie Building, The University of Manchester, Oxford Road, Manchester, M13 9PL, by emailing: [email protected]  or by telephoning 0161 275 2674.

If you wish to contact us about your data protection rights, please email [email protected] or write to The Information Governance Office, Christie Building, The University of Manchester, Oxford Road, M13 9PL at the University and we will guide you through the process of exercising your rights.

You also have a right to complain to the Information Commissioner’s Office about complaints relating to your personal identifiable information Tel 0303 123 1113.  The Information

Commissioner’s Offices complaints can be found at https://ico.org.uk/make-a-complaint/

 

In the event that something does go wrong and you are harmed during the research you may have grounds for a legal action for compensation against the University of Manchester but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you.

What support will be available to me?

We will check if you have any concerns following the study, and you will be able to talk to the trainee clinical psychologist about what to do next and what support is available. You can also speak with your GP, care worker or contact voluntary and professional support organisations such as:

Samaritans 24 hour helpline 116 123
Saneline 4:30pm – 10:30pm 0300 304 7000
Rethink 09:30am – 4:00pm 0300 5000 927
Mind Infoline 09.15am – 5.15pm 0845 766 0163
The Sanctuary 8pm – 6am 0161 637 0808

 

Contact Details

If you require any further information or have any questions about the study before you decide to participate, you can contact the researcher directly on the email address below.  Please note that the phone number provided will only be available during office hours (Monday to Friday, 9am to 5pm) during the study and should not be used in the event of a crisis or emergency.

 

Phil Docherty

Trainee Clinical Psychologist

[email protected]

Tel: +44 (0) 161 275 2595

 

 Dr Sara Tai

Consultant Clinical Psychologist

[email protected]

Tel: +44 (0) 161 275 2595

 

Thank you very much for reading this information sheet