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Improving the treatment of depression and quality of life in Parkinson’s disease: A randomised controlled trial

We would like to invite you and your partner/carer to participate in the following research, which will investigate the impact of mindfulness-based psychological treatment on mood and quality of life in Parkinson’s disease. The Curtin University (Ref: 217/2015) Human Research Ethics Committees have approved this study.

Nature and Purpose of the Study

This study is being conducted to see if a psychological treatment based on meditation principles called “Mindfulness Based Cognitive Therapy” (mindfulness) is an effective treatment for mood problems and stress in people with Parkinson’s disease.

You have been invited to take part in this study if you have Parkinson’s disease and are experiencing problems with low mood or stress.

What will the study involve? The study will involve several parts

Part 1) an initial assessment at the Curtin University Psychology Clinic that will take the form of a Structured Clinical Interview, which will last approximately one and a half hours. This will involve a standardised assessment of the motor symptoms of Parkinson’s including a number of simple motor tasks, an assessment of balance and various observations of speech, tremor, rigidity and posture. It will also involve answering a range of questions, and the completion of a number of questionnaires. Completion of the questionnaires will take approximately 1 hour.

Part 2) you will be randomly allocated (like the flip of a coin) into either an 8-week mindfulness based cognitive therapy (MBCT) program or an 8-week supportive group program. For both groups the sessions will run for 2 hours per week at Curtin University Psychology Clinic over 8 consecutive weeks.  These sessions will be video recorded. It is important that if you agree to take part in this study, you are able to commit to attending all 8 sessions.

Part 3) at the end of the 8-week period you will complete the same assessments as you did prior to the treatment program (see Part 1).

Part 4) you will be invited to take part in a 3-month and 6-month follow-up following completion of the treatment program. The follow-up will be conducted at Curtin University. You will be asked to complete a number of questionnaires. Completion of these questionnaires will take approximately 1 hour.

Those who were allocated to the supportive group program will be able to take part in the MBCT program after the 6-month follow-up.

How will the study involve my partner/carer?

We are running a session for partner/carers as part of the group treatment programs. This will involve educating your partner/carer about the impact of depression and anxiety in people with Parkinson’s disease. We will aim to encourage your partner/carer to also engage in practice of the psychological skills which we teach you. In order to see if your partner/carer is eligible to take part in the program a member of the research team will contact your partner/carer and invite them to come to Curtin University Psychology Clinic for a short 15-minute assessment. They will also be asked to complete a questionnaire relating to their experience of being a caregiver.  Your partner/carer will be required to provide written consent for their own participation in the study.

What if my partner/carer does not want to take part or is not eligible or I do not have a partner/carer?

You are still able to take part in the study without your partner/carer.

What about my medication?

We will ask you to continue to take your medication as normal. No changes will be made to your medication and you will not be asked to stop taking your current, or any new medication at any point during the study.

What are the possible benefits of taking part?

We cannot guarantee that you will benefit from taking part in the study, however the possible benefits of taking part in the study include improved mood, reduced stress and an improvement in quality of life. The information we gain from your participation may help us understand the impact of mindfulness treatment for depression and anxiety in people with Parkinson’s disease. The information we gain from your participation may help with clinical management of future patients with PD.

Are there any risks to taking part in the research project?

There are no foreseeable risks from taking part in the research project.

Confidentiality- who will have access to the data?

All data collected will be stored in a locked filing cabinet at Curtin University and in a password protected computer database in a secure system. All documents and questionnaires will be coded with an ID number. The video recordings taken during the intervention will be assessed only by the primary researcher and an external blind assessor and after this has been done the video files will be permanently deleted. After the study has been completed data will be stored for 25 years and will then be destroyed by shredding. The data will only be accessed by the researchers involved in the study.

Who is organising and funding the research?

This research has been organised by Curtin University, and is funded by a Fremantle Hospital Medical Research Foundation Research Award.

Do I have to take part?

Participation in this study is completely voluntary and you do not have to be involved in the study.  If you agree to take part, you retain the right to withdraw from the study at any time, without giving a reason and without prejudice.

We can refer you on to other services if you wish to have further support from another clinic instead of ours.  Your data will be destroyed if you decide to withdraw from the study.

What will happen to the study results?

The results of the study will be written into a manuscript for a Masters dissertation project. They will also be submitted to a peer-reviewed journal following the completion of the project. All of your identifying features will be removed in such cases.

All participants will have an opportunity to receive information about the overall results of the study. A sign-up sheet will be provided at the follow-up sessions for those wishing to be sent a summary sheet about the results once they are available.