Extrait

Background and study aims Most depression is treatable. However, about one in three patients with major depression responds poorly to currently available treatments and endures severely disrupted family, social and working life. Many chronically and treatment-resistant depressed (TRD) patients suffer from a personality disorder (PD) or problems such as being perfectionist, rigid or avoiding risks. Personality disorders are difficult to treat and patients with both depression and a PD respond poorly to drug therapies and psychological treatments like Cognitive Behavioural Therapy (CBT). Standard Dialectical Behaviour Therapy (DBT) has proved to be effective in treating borderline PD. Radically Open DBT (RO-DBT), a new treatment approach with strong roots in standard DBT, has demonstrated promise for patients with difficult-to-treat depression and related overcontrolled disorders. The aim of the study is to compare RO-DBT to Treatment as Usual (or standard clinical care). Who can participate? Men and women aged 18 or over who are suffering from TRD. TRD is defined as having had two or more previous episodes of depression or meeting the criteria for chronic depression, and being currently depressed without any symptom relief after having taken antidepressant medication for 6 or more weeks. What does the study involve? Participants will be randomly allocated to either the RO-DBT group or the Treatment as Usual group. Participants in both groups will receive standard treatment; this generally involves antidepressant medication prescribed by the GP or psychiatrist. The RO-DBT group will at the same time also receive 27 individual sessions and 29 group sessions for the duration of 7 months. Participants will be asked to come in for a discussion prior to the start of treatment and 7, 12, and 18 months later, and to complete several questionnaires once a month or every 2 months for the duration of 1 year to monitor symptom relief and quality of life. What are the possible benefits and risks of participating? We hope that either the standard treatment or RO-DBT will help patients by relieving them of their depression or significantly decrease symptoms of depression. The participants will be compensated for their time and effort while taking part in this study, provided they have completed all assessments. There are no risks associated with this study. Being part of this research will involve participants giving some of their time to complete the questionnaires and discuss with the researchers how they are feeling. Discussions and questionnaires may be upsetting if patients recall distressing events, but our previous work with depressed patients shows that most people return to their original emotional state following assessment. Where is the study run from? The study is coordinated from the University of Southampton, but assessments and treatment will take place at three NHS Psychological Therapy Services (Dorset, Hampshire and North Wales). When is the study starting and how long is it expected to run for? The study is expected to start in September 2011, and the duration of the study is 5 years. Recruitment for this study started in March 2012 and will continue until March 2015. Who is funding the study? This research grant has been awarded by the Efficacy and Mechanism Evaluation (EME) programme, which is funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR). Who is the main contact? Dr Roelie Hempel [email protected]

Critère d'inclusion

• depression

Liens

• isrctn
• ictrp