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The effectiveness of an augmented cognitive behavioural intervention for post-stroke depression with or without anxiety (PSDA): the Restore4Stroke-PSDA trial

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 P...

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Autores principales: Kootker, Joyce A, Fasotti, Luciano, Rasquin, Sascha MC, van Heugten, Caroline M, Geurts, Alexander CH
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3433315/
https://www.ncbi.nlm.nih.gov/pubmed/22769041
http://dx.doi.org/10.1186/1471-2377-12-51
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author Kootker, Joyce A
Fasotti, Luciano
Rasquin, Sascha MC
van Heugten, Caroline M
Geurts, Alexander CH
author_facet Kootker, Joyce A
Fasotti, Luciano
Rasquin, Sascha MC
van Heugten, Caroline M
Geurts, Alexander CH
author_sort Kootker, Joyce A
collection PubMed
description 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
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spelling pubmed-34333152012-09-05 The effectiveness of an augmented cognitive behavioural intervention for post-stroke depression with or without anxiety (PSDA): the Restore4Stroke-PSDA trial Kootker, Joyce A Fasotti, Luciano Rasquin, Sascha MC van Heugten, Caroline M Geurts, Alexander CH BMC Neurol Study Protocol 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 BioMed Central 2012-07-07 /pmc/articles/PMC3433315/ /pubmed/22769041 http://dx.doi.org/10.1186/1471-2377-12-51 Text en Copyright ©2012 Kootker et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Kootker, Joyce A
Fasotti, Luciano
Rasquin, Sascha MC
van Heugten, Caroline M
Geurts, Alexander CH
The effectiveness of an augmented cognitive behavioural intervention for post-stroke depression with or without anxiety (PSDA): the Restore4Stroke-PSDA trial
title The effectiveness of an augmented cognitive behavioural intervention for post-stroke depression with or without anxiety (PSDA): the Restore4Stroke-PSDA trial
title_full The effectiveness of an augmented cognitive behavioural intervention for post-stroke depression with or without anxiety (PSDA): the Restore4Stroke-PSDA trial
title_fullStr The effectiveness of an augmented cognitive behavioural intervention for post-stroke depression with or without anxiety (PSDA): the Restore4Stroke-PSDA trial
title_full_unstemmed The effectiveness of an augmented cognitive behavioural intervention for post-stroke depression with or without anxiety (PSDA): the Restore4Stroke-PSDA trial
title_short The effectiveness of an augmented cognitive behavioural intervention for post-stroke depression with or without anxiety (PSDA): the Restore4Stroke-PSDA trial
title_sort effectiveness of an augmented cognitive behavioural intervention for post-stroke depression with or without anxiety (psda): the restore4stroke-psda trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3433315/
https://www.ncbi.nlm.nih.gov/pubmed/22769041
http://dx.doi.org/10.1186/1471-2377-12-51
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