A randomized controlled trial of cognitive control training (CCT) as an add-on treatment for late-life depression: a study protocol

Abstract Background Already a major health concern, late-life depression (LLD) is expected to form an increasing problem in the aging population. Moreover, despite current treatments, LLD is associated with a poor long-term prognosis and high rate of chronicity. Treatment provision and treatment acc...

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Autores principales:	Bart Meuleman, Janna N. Vrijsen, Marie-Anne Vanderhasselt, Ernst H. W. Koster, Peter Oostelbos, Paul Naarding, Linda Bolier, Indira Tendolkar, Filip Smit, Jan Spijker, Eni S. Becker
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Cognitive control Late-life depression (cost-)effectiveness Psychiatry RC435-571
Acceso en línea:	https://doaj.org/article/7951ddef52f84662b179f0c0d145b2ff
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spelling	oai:doaj.org-article:7951ddef52f84662b179f0c0d145b2ff2021-11-28T12:06:54ZA randomized controlled trial of cognitive control training (CCT) as an add-on treatment for late-life depression: a study protocol10.1186/s12888-021-03597-11471-244Xhttps://doaj.org/article/7951ddef52f84662b179f0c0d145b2ff2021-11-01T00:00:00Zhttps://doi.org/10.1186/s12888-021-03597-1https://doaj.org/toc/1471-244XAbstract Background Already a major health concern, late-life depression (LLD) is expected to form an increasing problem in the aging population. Moreover, despite current treatments, LLD is associated with a poor long-term prognosis and high rate of chronicity. Treatment provision and treatment accordingly warrant improvement, where add-on treatments might contribute to the efficacy of conventional therapies. Although it is known that impaired cognitive control contributes to LDD, it is not targeted sufficiently by current interventions. Research on cognitive control training (CCT) shows promising results on depressive symptoms, cognitive performance, and overall functioning. However, further research is needed to determine the long-term effects of CCT on LLD, its cost-effectiveness, and mechanisms of change. Methods In the current multicenter randomized controlled trial (RCT) with a between-subjects design participants aged 60 years and over with a current LLD receiving treatment as usual (TAU) are randomized to add-on CCT or placebo training. Randomization is stratified by depression severity. Participants will receive eight online CCT or placebo sessions spread across four consecutive weeks. They will complete a post-training assessment after 1 month and three follow-up assessments scheduled three, six and 12 months after completing the training. We expect CCT and TAU to be more (cost-)effective in reducing depressive symptoms than placebo training and TAU. Additionally, we will be looking at secondary clinical, cognitive and global functioning outcomes and likely mechanisms of change (e.g., improved cognitive functioning, reduced rumination, and improved inhibition of negative stimuli). Discussion The proposed RCT aims to contribute to the clinical and scientific knowledge on the long-term effects of CCT as an add-on treatment for LLD. Cost-effectiveness is particularly relevant considering the expected volume of the target demographic. The study will be a pragmatic trial with few inclusion restrictions, providing information on feasibility of web-based trainings in clinical settings. The outcomes are potentially generalizable to guidelines for treatment of LLD. Trial registration This trial is registered in the Netherlands Trial Register (code: NL7639 ). Registered 3 april 2019.Bart MeulemanJanna N. VrijsenMarie-Anne VanderhasseltErnst H. W. KosterPeter OostelbosPaul NaardingLinda BolierIndira TendolkarFilip SmitJan SpijkerEni S. BeckerBMCarticleCognitive controlLate-life depression(cost-)effectivenessPsychiatryRC435-571ENBMC Psychiatry, Vol 21, Iss 1, Pp 1-12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Cognitive control Late-life depression (cost-)effectiveness Psychiatry RC435-571
spellingShingle	Cognitive control Late-life depression (cost-)effectiveness Psychiatry RC435-571 Bart Meuleman Janna N. Vrijsen Marie-Anne Vanderhasselt Ernst H. W. Koster Peter Oostelbos Paul Naarding Linda Bolier Indira Tendolkar Filip Smit Jan Spijker Eni S. Becker A randomized controlled trial of cognitive control training (CCT) as an add-on treatment for late-life depression: a study protocol
description	Abstract Background Already a major health concern, late-life depression (LLD) is expected to form an increasing problem in the aging population. Moreover, despite current treatments, LLD is associated with a poor long-term prognosis and high rate of chronicity. Treatment provision and treatment accordingly warrant improvement, where add-on treatments might contribute to the efficacy of conventional therapies. Although it is known that impaired cognitive control contributes to LDD, it is not targeted sufficiently by current interventions. Research on cognitive control training (CCT) shows promising results on depressive symptoms, cognitive performance, and overall functioning. However, further research is needed to determine the long-term effects of CCT on LLD, its cost-effectiveness, and mechanisms of change. Methods In the current multicenter randomized controlled trial (RCT) with a between-subjects design participants aged 60 years and over with a current LLD receiving treatment as usual (TAU) are randomized to add-on CCT or placebo training. Randomization is stratified by depression severity. Participants will receive eight online CCT or placebo sessions spread across four consecutive weeks. They will complete a post-training assessment after 1 month and three follow-up assessments scheduled three, six and 12 months after completing the training. We expect CCT and TAU to be more (cost-)effective in reducing depressive symptoms than placebo training and TAU. Additionally, we will be looking at secondary clinical, cognitive and global functioning outcomes and likely mechanisms of change (e.g., improved cognitive functioning, reduced rumination, and improved inhibition of negative stimuli). Discussion The proposed RCT aims to contribute to the clinical and scientific knowledge on the long-term effects of CCT as an add-on treatment for LLD. Cost-effectiveness is particularly relevant considering the expected volume of the target demographic. The study will be a pragmatic trial with few inclusion restrictions, providing information on feasibility of web-based trainings in clinical settings. The outcomes are potentially generalizable to guidelines for treatment of LLD. Trial registration This trial is registered in the Netherlands Trial Register (code: NL7639 ). Registered 3 april 2019.
format	article
author	Bart Meuleman Janna N. Vrijsen Marie-Anne Vanderhasselt Ernst H. W. Koster Peter Oostelbos Paul Naarding Linda Bolier Indira Tendolkar Filip Smit Jan Spijker Eni S. Becker
author_facet	Bart Meuleman Janna N. Vrijsen Marie-Anne Vanderhasselt Ernst H. W. Koster Peter Oostelbos Paul Naarding Linda Bolier Indira Tendolkar Filip Smit Jan Spijker Eni S. Becker
author_sort	Bart Meuleman
title	A randomized controlled trial of cognitive control training (CCT) as an add-on treatment for late-life depression: a study protocol
title_short	A randomized controlled trial of cognitive control training (CCT) as an add-on treatment for late-life depression: a study protocol
title_full	A randomized controlled trial of cognitive control training (CCT) as an add-on treatment for late-life depression: a study protocol
title_fullStr	A randomized controlled trial of cognitive control training (CCT) as an add-on treatment for late-life depression: a study protocol
title_full_unstemmed	A randomized controlled trial of cognitive control training (CCT) as an add-on treatment for late-life depression: a study protocol
title_sort	randomized controlled trial of cognitive control training (cct) as an add-on treatment for late-life depression: a study protocol
publisher	BMC
publishDate	2021
url	https://doaj.org/article/7951ddef52f84662b179f0c0d145b2ff
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A randomized controlled trial of cognitive control training (CCT) as an add-on treatment for late-life depression: a study protocol

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