Abstract
BackgroundPost-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/designA 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.DiscussionThis 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 registrationTrial registration number: Dutch Trial Register NTR2999
Highlights
Building rapport; discussing grief; psycho-education about the relationship between mood and behaviour.2
Stressing the impact and co-occurrence of anxiety on patients with stroke, in the present study, we introduce the new concept of ‘Post-Stroke Depression with or without Anxiety’ (PSDA)
Currently, no multi-centre Randomised Controlled Trial (RCT) has been conducted that has evaluated the effectiveness of an cognitive behavioural therapy (CBT) intervention on post-stroke depression with or without anxiety [47]
Summary
No multi-centre RCT has been conducted that has evaluated the effectiveness of an (augmented) CBT intervention on post-stroke depression with or without anxiety [47]. The protocol continually emphasizes CRASS communication principles, and the ACS is offered as a tool to provide input for conversation about joyful activities Another innovation in the present study is that depressive symptoms are used for inclusion of subjects, but that symptoms of anxiety are not considered a reason for exclusion. An important methodological aspect of the present study is that subjects from different parts of the Netherlands are included, which will enable us to control for possible cultural differences between subgroups Another methodological strength is that the augmented CBT is compared to an ‘active’ intervention (and not to ‘usual care’) to control for Hawthorne effects.
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