Extrait

Background and study aims Many patients with depression who are prescribed antidepressants by their GP do not get better after 6 weeks of treatment. Currently there is little evidence about what alternative treatment options doctors should discuss with patients at this time. Cognitive behavioural therapy (CBT) is a type of ‘talking therapy’ that has been shown to help patients with mild to moderate depression but there is little evidence about its effectiveness in patients who have not initially responded to antidepressants. In this study, we will examine whether patients who have not got better on antidepressants and go on to receive CBT as well as their medication are more likely to get better than patients who just continue to take their antidepressants over 12 months. We will also look at how much this treatment costs and patients' views and experiences of it. Who can participate? Patients aged 18-75 with depression who have been taking antidepressants for at least 6 weeks. What does the study involve? Patients will be invited to participate by their GP (in person or by letter) and those who are interested will be invited to meet with a researcher to discuss their participation in the study. All patients will be asked to sign a consent form to confirm that they fully understand what the study will involve. If you are eligible and willing to take part in the research, you will then be randomly allocated to one of two treatment groups, either: (1) CBT in addition to usual care, which includes antidepressants; or (2) usual care, including antidepressants. If you are included in Group 1, you will be invited to attend CBT sessions. Each session will last 50 minutes. Sessions will initially take place once a week but later on you and your therapist may decide that these sessions will occur less frequently. You would receive 12-18 sessions of CBT over about 6 months. If you are included in Group 2, you will continue to be under the normal care of your GP for the management of your depression. There will be no restrictions on the treatments that you can receive. Participants will be asked to complete a questionnaire at this time and again after 3, 6, 9 and 12 months. By comparing the two groups, we will be able to determine whether CBT is an effective treatment for this patient group. Participants will also be asked for their permission for the research team to have access to your medical records held at your GP’s surgery and to any hospital records. You would also be asked to give your consent for any CBT treatment sessions to be recorded using a digital voice recorder. What are the possible benefits and risks of participating? We hope that the treatment will help those who take part. However, this cannot be guaranteed. The results of the study will help doctors in the future to decide on the best treatment for someone who is depressed. Some of the questions that you will be asked during the assessment are personal and sometimes people can find it upsetting to discuss these issues. However, you don't have to answer anything you don't want to. The researcher will be able to offer support during the appointment if you are upset, but would also contact the doctors or care workers who normally provide care for you, if further support is necessary. Where is the study run from? University of Bristol (UK). When is the study starting and how long is it expected to run for? The study started in May 2008 and will run until March 2015. Who is funding the study? NIHR Health Technology Assessment Programme - HTA (UK). Who is the main contact? Dr Nicola Wiles [email protected]

Critère d'inclusion

• depression

Liens

• ictrp
• isrctn