Details of HTA project in progress
Last updated: 1 February 2012 - Next update due: 8 February 2012
Research type: |
Primary Research (e.g. trial) |
Project title: |
Preventing depressive relapse in NHS Practice through mindfulness-based cognitive therapy (MBCT) |
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Project ref: |
08/56/01 |
Cost: |
£1,828,161 |
Chief Investigator : |
Professor Willem Kuyken, Associate Professor in Clinical Psychology, School of Psychology, University of Exeter |
Project Website |
http://www.prevent-southwest.org.uk |
Start Date: |
January 2010 |
Estimated date of publication in HTA journal series: |
Mid 2015. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
BACKGROUND TO THE RESEARCH Depression is an extremely common and disabling mental health problem that is most commonly treated in the NHS with antidepressant drugs. Even though antidepressant drugs help many people with depression get well, the rates of people getting depressed again are very high. Also, service users often express a wish for psychological help that can help them recover from depression in the long-term. We need to develop psychological therapies that prevent depression coming back repeatedly that will be easy for service users to access in the NHS. A recently developed treatment, Mindfulness-based Cognitive Therapy (shortened to MBCT, see www. mbct.co.uk) shows potential as a brief group programme for people with recurring depression. In two studies it has been shown to halve the rates of depression recurring compared to normal NHS treatment. Mindfulness-based Cognitive Therapy is a therapy for people who have experienced a lot of depression and works by helping people to learn skills that can prevent depression coming back. People learn these skills in eight weekly two hour classes of up to 15 people who have had similar experiences. Patients say that they find the treatment accessible and helpful. OUR RESEARCH QUESTIONS We would like to find out how well MBCT works compared with the current treatment of choice (anti-depressants drugs) within a standard NHS setting. We also want to find out how it works. OUR RESEARCH METHODS This study will be set in real world NHS primary care settings and will recruit people with a history of recurrent depression who are interested in a psychological approach to staying well in the long-term. The study involves a number of stages: (1) an initial getting to know participants' in terms of their current and past mental health, (2) allocation to one of three therapies for recurring depression (staying on anti-depressants, MBCT and a version of MBCT that doesn't require extensive meditation practice) and (3) seeing how participants are doing at regular intervals over 24 months. In the two MBCT groups, once patients have learned coping skills they will be invited to discuss with the GP tapering and discontinuing their anti-depressant medication. To see if MBCT offers an alternative to staying on antidepressants long-term we will see if the patients who participate in MBCT stay as well as those who receive ongoing antidepressant treatment. The regular follow ups will ask: have people stayed well, how is their quality of life, how are they functioning, are they continuing to take antidepressants and what services are they using? We have included a broader set of outcomes because they are valued by service users. To find out how MBCT works we will: ask people about their experiences of MBCT and assess the things we think MBCT changes (e.g., coping skills to prevent depression returning) before and after treatment. ETHICAL CONSIDERATIONS There is evidence to suppose that all three treatment arms will help participants preventing depression reoccurring. Staying on anti-depressants and MBCT have both been recommended as helpful treatments for recurrent depression. Although there are good reasons to suppose that the group treatment without the extensive meditation component will also be found to be effective we cannot guarantee that these treatments will help all patients. However, the results of the study is intended to help us treat future patients with depression better. We will keep an eye on everyone in the study to see how they are doing. If anyone shows signs of suffering a relapse of depression we will help ensure they have access to appropriate help. Being part of this research will involve participants giving their time to complete the questionnaires and discuss with the researchers how they are doing at regular intervals. Participants in the two group treatments will have to undertake to attend the group meetings and do the homework. They will also be invited to come off their antidepressants in a way they and their GP agree is appropriate. If at any time participants find that coming off their antidepressants is not helpful (for example having symptoms come back and feeling unable to cope with these), then they and their GP will need to consider the best course of action to keeping well. The research team will help by monitoring how participants are doing and by proving training and support to GPs. Participants in the antidepressant group will have to undertake to continue their antidepressants for two years in line with normal practice for people who have experienced recurrent depression. IMPLICATIONS OF THE WORK Answers to these questions will potentially enable patients and GPs to make informed choices about a psychological approach to relapse prevention in the NHS as an alternative to staying on antidepressants long-term. Knowing how MBCT works is important because it enables us to make MBCT work better. If mindfulness is not essential, then we can find simpler and more cost-effective ways of helping people stay well. THE STUDY TEAM AND PROJECT COSTS The study team is ideally placed to do this research because it has recently completed an exploratory study that laid the groundwork for this proposal. The findings will be published later this year, but provide evidence that this proposed study is feasible and offer promising evidence that MBCT may actually do better than antidepressants in helping people stay well long-term (Kuyken et al). The main cost of this study is employing research workers to work in GP practices to identify people who may be interested in participating, inviting these people to participate and then following study participants up over two years. In addition we will ask the NHS to contribute to employing four part time therapists to offer the group treatments and to support the GP practices in their contribution to the project. |
Project Abstract: |
BACKGROUND TO THE RESEARCH. Depression is an extremely common and disabling mental health problem that is most commonly treated in the NHS with antidepressant drugs. Even though antidepressant drugs help many people with depression get well, the rates of people getting depressed again are very high. Also, service users often express a wish for psychological help that can help them recover from depression in the long-term. We need to develop psychological therapies that prevent depression coming back repeatedly that will be easy for service users to access in the NHS. A recently developed treatment, Mindfulness-based Cognitive Therapy (shortened to MBCT, see www. mbct.co.uk) shows potential as a brief group programme for people with recurring depression. In two studies it has been shown to halve the rates of depression recurring compared to normal NHS treatment. Mindfulness-based Cognitive Therapy is a therapy for people who have experienced a lot of depression and works by helping people to learn skills that can prevent depression coming back. People learn these skills in eight weekly two hour classes of up to 15 people who have had similar experiences. Patients say that they find the treatment accessible and helpful. OUR RESEARCH QUESTIONS. We would like to find out how well MBCT works compared with the current treatment of choice (anti-depressants drugs) within a standard NHS setting. We also want to find out how it works. OUR RESEARCH METHODS. This study will be set in real world NHS primary care settings and will recruit people with a history of recurrent depression who are interested in a psychological approach to staying well in the long-term. The study involves a number of stages: (1) an initial getting to know participants' in terms of their current and past mental health, (2) allocation to one of two therapies for recurring depression (staying on anti-depressants and MBCT) and (3) seeing how participants are doing at regular intervals over 24 months. In the MBCT groups, once patients have learned coping skills they will be invited to discuss with the GP tapering and discontinuing their anti-depressant medication. To see if MBCT offers an alternative to staying on antidepressants long-term we will see if the patients who participate in MBCT stay as well as those who receive ongoing antidepressant treatment. The regular follow ups will ask: have people stayed well, how is their quality of life, how are they functioning, are they continuing to take antidepressants and what services are they using? We have included a broader set of outcomes because they are valued by service users. To find out how MBCT works we will ask people about their experiences of MBCT and assess the things we think MBCT changes (e.g., coping skills to prevent depression returning) before and after treatment. |
ISRCTN* number: | ISRCTN 26666654 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN26666654 |
Project Protocol: |
Project protocol (pdf format, 487 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1924 |
Outputs from this project
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