Study protocol
The effectiveness of an augmented cognitive behavioural intervention for post-stroke depression with or without anxiety (PSDA): the Restore4Stroke-PSDA trial
1 Department of Rehabilitation, Nijmegen Centre for Evidence Based Practice, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
2 Donders Institute for Brain, Cognition and Behaviour, Radboud University Nijmegen, Nijmegen, The Netherlands
3 Rehabilitation Medical Centre Groot Klimmendaal, Arnhem, The Netherlands
4 Adelante Rehabilitation Foundation Limburg, Limburg, The Netherlands
5 Dept Rehabilitation, CAPHRI, Maastricht University Medical Centre, Maastricht, The Netherlands
6 Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Faculty of Health, Medicine and Life Sciences, Maastricht, The Netherlands
7 Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands
BMC Neurology 2012, 12:51 doi:10.1186/1471-2377-12-51
Published: 7 July 2012Abstract
Background
Post-Stroke Depression with or without Anxiety (PSDA) is a common disorder in the chronic phase of stroke. Neuropsychiatric problems, such as PSDA, have a negative impact on social reintegration and quality of life. Currently, there is no evidence-based treatment available for reducing PSDA symptoms. In the recent literature on depression in the general population it has been shown that depression complaints can diminish by cognitive behavioural therapy (CBT). In the current study, the effectiveness of augmented, activation-based and individually tailored CBT on the reduction of depression and anxiety will be investigated in patients with PSDA. Additionally, the effects on various secondary outcome measures, such as quality of life, goal attainment and societal participation will be evaluated. This study is embedded in a consortium of 4 interrelated studies on quality of life after stroke (Restore4Stroke).
Methods/design
A multi-centre, assessor-blind, randomized controlled trial is conducted. A sample of 106 PSDA patients, as assessed with the Hospital Anxiety and Depression Scale (HADS depression subscale >7), will be recruited and randomly allocated to either an experimental or a control group. The experimental intervention consists of an augmented CBT intervention. The intervention is based on CBT principles of recognizing, registering, and altering negative thoughts and cognitions so that mood, and emotional symptoms are improved. CBT is augmented with direct in-vivo activation offered by occupational or movement therapists. Patients in the control group will receive a computerized cognitive training intervention. Outcomes will be assessed at baseline, immediately post intervention, and at 6 and 12 months follow up.
Discussion
This study is the first randomized clinical trial that evaluates the (maintenance of) effects of augmented CBT on post-stroke depression with or without anxiety symptoms. Together with three other projects, the Restore4Stroke PSDA trial will provide novel information about the (treatment of) emotional problems and quality of life after stroke.
Trial registration
Trial registration number: Dutch Trial Register NTR2999
