Family Focused Therapy for Bipolar Disorder (Clinical Case Series) Participant Information Sheet Study Title: Family Focused Therapy for Bipolar Disorder: A Clinical Case Series) We would like to invite you to take part in a family therapy research study. Family therapy recognises that bipolar disorder can impact on all members of the family and helps people work together to find ways to improve wellbeing for everyone. Before you decide whether you would like to take part, it is important that you understand why this research is being done and what it will involve. Please take the time to read the following information carefully and discuss this with others if you wish. Please ask us if there is anything that is unclear or that you would like more information about. Take time to decide whether or not you wish to take part. What is the research project about? This study aims to explore the use of family focused therapy for bipolar disorder. In particular, the study wants to find how interested people are in this, what they find most useful, and how much effective it is in enhancing mood, preventing relapse and improving well being for family members. Both positive and negative feedback about your experience with the therapy is central to the study in order to develop useful interventions for other service users. Who is organising the research? This project is being organised by a team of researchers, service users and health professionals from Lancaster University. Recruitment is supported through local NHS Trusts (MMHSCT, Greater Manchester West Mental Health NHS Foundation Trust, Cumbria PCT, Cumbria Partnership, Lancashire Care). The research study involves a series of interviews, which will be conducted by a researcher who is employed by the project. Initially, they will be asking participants about experiences of bipolar disorder, including questions about symptoms, quality of life, coping style, family relationships. Similarly, we will ask family members of participants about family relationships, care giving and general health and wellbeing. We will then invite you as a family to commit to family focused therapy with a therapist who will provide up to 18 sessions over a six month period. Additional interviews will be conducted throughout the period of therapy in order to determine whether or not you are finding it beneficial. Who will be taking part? Up to a 12 participants from within the UK North West area will take part in the study. Participants will be aged between 18-65, have experience of bipolar disorder; have at least one family member (whom they see for at least 4 hours per week) interested in participating; feel that his/her family would benefit from support for the family in terms of relationship quality, relationship distress and/or improving communication; are able to understand spoken and written English and have access to a computer, the internet, an email address and telephone. If you are participating in another research study investigating a psychological intervention, or are receiving a psychological intervention as part of your usual care you may not be able to take part please discuss this with a member of the research team. If you have a learning disability/ organic Version 2.2 1 FFT for BD (Clinical Case Series)
brain injury that impairs your ability to complete the assessments/ engage in the therapy, then unfortunately you will not be able to participate Why have I been asked to take part? You have been asked to take part because of your experience of bipolar disorder and because you live in the UK North West. We think that you could make a valuable contribution to this research project. Do I have to take part? It is completely up to you to decide whether or not you would like to take part. If you do decide to take part you will be given a copy of this information sheet and asked to sign a consent form. If you do decide to take part but change your mind later you are free to withdraw at any time and do not need to give us a reason. If you do decide not to take part, or to withdraw at any time, this will not affect the standard of care you receive. However, if you decide to withdraw, then the information collected so far cannot be erased, and this information may still be used in the analysis and publication of this study. If during the study you become unwell and are judged unable to give consent to take part, we will withdraw you from the study and provide you the opportunity to reenter the study once you become well again. What will taking part involve for me? Initial assessment (part 1): If you decide to take part in the study, a research assistant will arrange a time to come and meet you either at the Spectrum Centre, at your home or at another place where you feel comfortable. To begin with, the research assistant will conduct a comprehensive interview that contains questions about your history of mood and related experiences. You will also be asked some questions about your educational, social, occupational and family life. This information will be used to confirm whether you meet research criteria for entry into the study. This interview should take around a total of 60-90minutes and will be audio taped. We will be taping it to ensure that the researchers are following the manual consistently. You can have as many breaks as you like during the interviews and can stop at any time. If you are not eligible, you will not be required to complete any more assessments and will not be able to participate in the family focused psychological intervention. However, if you would like to remain informed about future research and activities, you are welcome to join our participant panel Spectrum Connect (http://www.spectrumconnect.co.uk). If you are eligible you will be asked to complete a consent form. The RA will then have a discussion with you about which family member(s) may be interested in participating, and if they are present, the RA can answer any questions they may have. The RA will provide an information sheet and self referral form for you to pass on to any family members you think may be interested, Initial assessment (part 2): Once we have received a self referral form from at least one of your family members, the RA will arrange another time to come and meet you and your family member(s) either at the Spectrum Centre, at your home or at another place where you feel comfortable. Your family member(s) will be have the chance to ask any questions, and then they will be asked to complete their own consent forms. They will also be asked to complete some self report questionnaires on care giving, general health and relationships that will take approximately 30 minutes to complete. You will be asked to complete a range of brief self-report questionnaires assessing mood, thoughts, quality of life and coping style. These can be completed on-line, or with the help of the research assistant and this should take approximately one hour to complete. Baseline period: You will be randomly allocated to a baseline length of between four and eight weeks. That is, you will be asked to wait between four and eight weeks before you start therapy. Version 2.2 2 FFT for BD (Clinical Case Series)
This duration will be chosen completely at random and is designed to help us work out if any changes experienced are related to the start of therapy or due to other unrelated factors. As some people experience frequent mood changes, in order to get a clear picture of your general average mood, during this period, you will be asked to complete two brief self-report questionnaires (4 minutes) on a weekly basis. You will receive a weekly email containing a direct link to these questionnaires. You will be asked to complete the questionnaires within three days of receiving this email. In the current study, in order to more clearly measure the effect of the family focused intervention, it is important that people s mood is relatively stable before they begin therapy. That is, the intensity/ frequency of mood symptoms do not substantially fluctuate from week to week. Therefore, at the end of your allocated baseline period, the research assistant will contact you to arrange a convenient time to talk to you about your mood and related experiences. If you have not experienced a clinical mood episode within the previous three weeks and your self-reported mood scores are relatively consistent, you will be invited to start therapy. If this is not the case, you will be asked to wait a bit longer (maximum of eight weeks). If we find that your mood is not stable and you would still like to participant, we will suggest that we re-contact you in a few months time to see if your mood has stabilized. Baseline assessment: Once your mood is stable we will then contact you by phone within one week to request that you complete the baseline assessment. This is very similar to the initial assessment and includes some brief interviews, questionnaires about your mood, thoughts and quality of life. Family members will also be asked to complete a brief interview and some questionnaires. You may choose to complete these face to face with the researcher, online or over the phone and it is expected that this would take approximately one hour for you and 30 minutes for your family member(s). Family focused therapy: You and your family member will be offered weekly family therapy sessions with a clinician. Sessions can be held in a therapy room at the Spectrum Centre or at your home if you would be more comfortable. Session one will include all family members wishing to participate, and the therapist will have the chance to meet everyone and discuss the rationale for the family therapy approach. Individual sessions with the therapist will be offered for each family member in order for the therapist to obtain individual perspectives. All family members involved will be invited to attend session 2, and all other therapy sessions, together. Sessions can last up to 1 hour and there is up to 18 sessions for you to attend within a 6 month period. Assessments A: During the six month therapy period, you will be asked to complete weekly questionnaires about your mood, behaviours, thoughts and coping. You will also be asked to complete a questionnaire about how you feel you can relate to your therapist. This questionnaire will not be seen by your therapist at any stage. You may be asked to attend your appointments 30 minutes early to complete the assessments using a research computer. Alternatively, you may receive a weekly email containing a direct link to the assessment instruments. It is important that you complete these measures within three days of receiving the email. Once the six month therapy phase has finished, the frequency of these assessments will be reduced to monthly for the remaining 6 months of the study. You will receive a monthly reminder email containing a direct link to the assessment instruments. During this phase, it is important that these measures are completed within a week of receiving the email Assessments B: We would like to contact you by phone at 3, 6, 9, and 12, months after you started the project to complete an interview and some self report questionnaires with the research assistant to see what impact (if any) the intervention had for you and your family. It is expected that this would take 60-90 minutes on each occasion. You may choose to complete the self report questionnaires online if you prefer. Version 2.2 3 FFT for BD (Clinical Case Series)
Assessments C: We would like to contact your family member by phone at 3,6, 9, and 12, months after they started the project to complete a five minute interview and some self report questionnaires on supporting you and their own coping. These questionnaires should take no longer than 30minutes. All the information that you give will be strictly confidential; the transcript of the interviews will not be shown to anyone outside the research team. All interviews will be transcribed so we have a record of what was discussed. The information (data) collected will be anonymised, tapes will be destroyed at the end of the study and any direct quotes used in the write up of the study will be done so in such a way so as not to identify individuals. Audio taping of assessment and therapy sessions: Before you agree to participate in the study, you will be asked to give your permission for your initial, baseline, therapy and follow-up appointments to be audio-recorded. These recordings will only be accessible to the research team. They will be used to ensure that the information you have provided has been documented accurately, to confirm that the researchers are using assessment and therapy materials consistently and for the purposes of supervision. You can withdraw your consent at any time. The researcher will ask for your verbal consent at the beginning of each appointment. If you do not wish to have your appointments recorded, this will not affect your ability to participate in the study. Involving members of your healthcare team: Before you agree to participate, you will be asked to give permission for the research team to inform relevant members of your healthcare team (including the person who may have referred you) that you will be involved in the study. We will also need permission to contact your healthcare team to discuss any issues related to safety. We would like to send a letter at the beginning of the study, once you have stopped therapy and once you have finished participating. This letter will contain a summary of your participation including duration of involvement and self-report assessment scores (mood and quality of life). However, if you do not wish to have your health care team informed of these results, this will not affect your ability to participate in the study. How will my privacy be protected? Only members of the immediate research team with relevant ethical clearance will have access to your information. All the information that you give will be strictly confidential. This information will be disclosed only with your permission or except as required by law. For example, if you share information that leads a member of our staff to be concerned about your (or another person s) safety/ wellbeing/ involvement in criminal activity, then we may have a legal obligation to disclose this information (e.g. to a health/ social care provider; family member; emergency services). If there is a need to disclose risk related information, where possible, our staff will let you know what information needs to be shared, and with whom. Your personal details will be accessed, used and stored as required by Law and in accordance with relevant guidelines. All files will be kept securely stored in a locked area of Spectrum Centre, Lancaster University for a period of seven years after which all identifying information will be shredded. At the start of the project, you will be given a participant number. This number will be used to identify all of the information that you provide for this project. Your name, address, and other identifying details will be removed from this information. If you are under the care of an NHS Trust, a copy of your consent form may be copied into your usual medical notes and this copy may be reviewed by the Trust Clinical Audit Department to confirm that you have given written consent to take part. Version 2.2 4 FFT for BD (Clinical Case Series)
What are the advantages and disadvantages of taking part? The study will give you the opportunity to receive free family therapy with a clinician accredited with the British Association for Behavioural and Cognitive Psychotherapies (BABCP), or equivalent, over a period of 6 months. We hope that by collecting data on the impact of this intervention we will be able to inform and influence the practice of mental health professionals in delivering treatment and interventions to you and other service users. The family focussed therapy aims to provide psychoeducation to assist you and your close relatives to understand the nature of bipolar disorder, including the origins and course of the disorder and a rationale for treatment. It also aims to assist you and your family members to establish and re-establish effective communication patterns, and provides skill building in conflict resolution. It is possible that talking about your personal experiences may result in some distress. The people interviewing you will be sensitive to this. You will have the opportunity to discuss any concerns at the end of the interview and you are free to withdraw from the process at any point. We will check if there are any concerns you wish to raise, and if necessary you will be able to talk to one of the clinical psychologists on the research team. What do I do if something goes wrong? In the unlikely event that you are harmed by taking part in this research project, there are no special compensation arrangements. If you are harmed due to someone s negligence, then you may have grounds for legal action but you may have to pay for it. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, then in the first instance please contact: Dr Fiona Lobban, Associate Director of the Spectrum Centre for Mental Health Research, Lancaster University, Lancaster, LA1 4WY. Tel: 01524 593752 Email: f.lobban@lancaster.ac.uk If you would prefer to contact someone independent of the research with any concerns, please contact: Professor Paul Bates, Associate Dean for Research, Division of Health Research, Lancaster University, Lancaster, LA1 4YG. Tel: 01524593718 Email: p.bates@lancaster.ac.uk If your complaint relates to an NHS employee, or something that occurred within an NHS facility, you can get help and advice from PALS (Patient Advice and Liaison Services). You can find your nearest PALS office using the directory on the PALS website: http://www.pals.nhs.uk/officemapsearch.aspx What will happen to the results of the research? If you participate in the study you will be informed of the results. The findings will also be presented to a range of mental health professionals and service users with the aim of increasing the understanding of what it is like to experience bipolar disorder. It is hoped that the findings will also help to improve services and validate the experiences of other service users. The findings will be published in mental health journals and other publications with the aim of reaching a range of mental health professionals and service users. If you want any further information or have any questions, please contact the research team on this project: Dr Gerasimos Chatzidamianos: g.chatzidamianos@lancaster.ac.uk, or 01524 592881 Version 2.2 5 FFT for BD (Clinical Case Series)