title: The effectiveness of an augmented cognitive behavioural intervention for post-stroke depression with or without anxiety (PSDA): the Restore4Stroke-PSDA trial.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  Dutch Trial Register NTR2999.
authors: Department of Rehabilitation, Nijmegen Centre for Evidence Based Practice, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. j.kootker@reval.umcn.nl
authors: Joyce A
authors: JA
authors: Kootker
authors: Luciano
authors: L
authors: Fasotti
authors: Sascha Mc
authors: SM
authors: Rasquin
authors: Caroline M
authors: CM
authors: van Heugten
authors: Alexander Ch
authors: ACh
authors: Geurts
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001007:Anxiety / Q000453:epidemiology* / Q000534:rehabilitation*; D015928:Cognitive Behavioral Therapy / Q000706:statistics & numerical data*; D015897:Comorbidity; D003863:Depression / Q000453:epidemiology* / Q000534:rehabilitation*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D015995:Prevalence; D020521:Stroke / Q000453:epidemiology*; D000071939:Stroke Rehabilitation; D016896:Treatment Outcome