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Open Access 01-12-2021 | Mood Disorders | Study protocol

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

Authors: 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

Published in: BMC Psychiatry | Issue 1/2021

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.

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Title: A randomized controlled trial of cognitive control training (CCT) as an add-on treatment for late-life depression: a study protocol
Authors: 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
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Mood Disorders
Affective Disorder
Published in: BMC Psychiatry / Issue 1/2021
Electronic ISSN: 1471-244X
DOI: https://doi.org/10.1186/s12888-021-03597-1

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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