Computerised cognitive training tools and online nutritional group counselling for people with mild cognitive impairment: study protocol of a completely digital, randomised, controlled trial
Introduction People with mild cognitive impairment (MCI) are at increased risk of decreasing cognitive functioning. Computerised cognitive training (CCT) and nutrition have been shown to improve the cognitive capacities of people with MCI. For each variable, we developed two kinds of interventions s...
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/7/e060473.full |
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| author | Stephanie Book Elmar Graessel Julia Schneider Michael Jeitler Petra Scheerbaum Michael Jank Etienne Hanslian Melanie DellO’ro Julia-Sophia Scheuermann Sophia Bösl Christian Kessler |
| author_facet | Stephanie Book Elmar Graessel Julia Schneider Michael Jeitler Petra Scheerbaum Michael Jank Etienne Hanslian Melanie DellO’ro Julia-Sophia Scheuermann Sophia Bösl Christian Kessler |
| author_sort | Stephanie Book |
| collection | DOAJ |
| description | Introduction People with mild cognitive impairment (MCI) are at increased risk of decreasing cognitive functioning. Computerised cognitive training (CCT) and nutrition have been shown to improve the cognitive capacities of people with MCI. For each variable, we developed two kinds of interventions specialised for people with MCI (CCT: ‘individualised’ CCT; nutrition: a whole-food, plant-based diet). Additionally, there are two kinds of active control measures (CCT: ‘basic’ CCT; nutrition: a healthy diet following the current guidelines of the German Nutrition Society). The aim of this study is to investigate the effects of the two interventions on cognition in people with MCI in a 2×2 randomised controlled trial with German participants.Methods and analysis Participants will be community-dwelling individuals with a psychometric diagnosis of MCI based on the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination. With N=200, effects with an effect size of f≥0.24 (comparable to Cohen’s d≥0.48) can be detected. Screening, baseline, t6 and t12 testing will be conducted via a videoconferencing assessment, telephone, and online survey. Participants will be randomly allocated to one of four groups and will receive a combination of CCT and online nutritional counselling. The CCT can be carried out independently at home on a computer, laptop, or tablet. Nutrition counselling includes 12 online group sessions every fortnight for 1.5 hours. The treatment phase is 6 months with follow-ups after six and 12 months after baseline.Ethics and dissemination All procedures were approved by the Friedrich-Alexander-Universität Erlangen-Nürnberg Ethics Committee (Ref. 21-318-1-B). Written informed consent will be obtained from all participants. Results will be published in peer-reviewed scientific journals, conference presentations.Trial registration number ISRCTN10560738. |
| format | Article |
| id | doaj-art-be7a0c4eccc64da3a67882dedeaa0394 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-be7a0c4eccc64da3a67882dedeaa03942025-01-31T17:35:11ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-060473Computerised cognitive training tools and online nutritional group counselling for people with mild cognitive impairment: study protocol of a completely digital, randomised, controlled trialStephanie Book0Elmar Graessel1Julia Schneider2Michael Jeitler3Petra Scheerbaum4Michael Jank5Etienne Hanslian6Melanie DellO’ro7Julia-Sophia Scheuermann8Sophia Bösl9Christian Kessler10Centre of Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, GermanyCentre of Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, GermanySchool of Rehabilitation Science, McMaster University, Hamilton, Ontario, CanadaInstitute of Social Medicine, Epidemiology and Health Economics, Charite University Hospital, Berlin, GermanyCentre of Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, GermanyCentre of Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, GermanyInstitute of Social Medicine, Epidemiology and Health Economics, Charite University Hospital, Berlin, GermanyInstitute of Social Medicine, Epidemiology and Health Economics, Charite University Hospital, Berlin, GermanyCentre of Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, GermanyCentre of Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, GermanyInstitute of Social Medicine, Epidemiology and Health Economics, Charite University Hospital, Berlin, GermanyIntroduction People with mild cognitive impairment (MCI) are at increased risk of decreasing cognitive functioning. Computerised cognitive training (CCT) and nutrition have been shown to improve the cognitive capacities of people with MCI. For each variable, we developed two kinds of interventions specialised for people with MCI (CCT: ‘individualised’ CCT; nutrition: a whole-food, plant-based diet). Additionally, there are two kinds of active control measures (CCT: ‘basic’ CCT; nutrition: a healthy diet following the current guidelines of the German Nutrition Society). The aim of this study is to investigate the effects of the two interventions on cognition in people with MCI in a 2×2 randomised controlled trial with German participants.Methods and analysis Participants will be community-dwelling individuals with a psychometric diagnosis of MCI based on the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination. With N=200, effects with an effect size of f≥0.24 (comparable to Cohen’s d≥0.48) can be detected. Screening, baseline, t6 and t12 testing will be conducted via a videoconferencing assessment, telephone, and online survey. Participants will be randomly allocated to one of four groups and will receive a combination of CCT and online nutritional counselling. The CCT can be carried out independently at home on a computer, laptop, or tablet. Nutrition counselling includes 12 online group sessions every fortnight for 1.5 hours. The treatment phase is 6 months with follow-ups after six and 12 months after baseline.Ethics and dissemination All procedures were approved by the Friedrich-Alexander-Universität Erlangen-Nürnberg Ethics Committee (Ref. 21-318-1-B). Written informed consent will be obtained from all participants. Results will be published in peer-reviewed scientific journals, conference presentations.Trial registration number ISRCTN10560738.https://bmjopen.bmj.com/content/12/7/e060473.full |
| spellingShingle | Stephanie Book Elmar Graessel Julia Schneider Michael Jeitler Petra Scheerbaum Michael Jank Etienne Hanslian Melanie DellO’ro Julia-Sophia Scheuermann Sophia Bösl Christian Kessler Computerised cognitive training tools and online nutritional group counselling for people with mild cognitive impairment: study protocol of a completely digital, randomised, controlled trial BMJ Open |
| title | Computerised cognitive training tools and online nutritional group counselling for people with mild cognitive impairment: study protocol of a completely digital, randomised, controlled trial |
| title_full | Computerised cognitive training tools and online nutritional group counselling for people with mild cognitive impairment: study protocol of a completely digital, randomised, controlled trial |
| title_fullStr | Computerised cognitive training tools and online nutritional group counselling for people with mild cognitive impairment: study protocol of a completely digital, randomised, controlled trial |
| title_full_unstemmed | Computerised cognitive training tools and online nutritional group counselling for people with mild cognitive impairment: study protocol of a completely digital, randomised, controlled trial |
| title_short | Computerised cognitive training tools and online nutritional group counselling for people with mild cognitive impairment: study protocol of a completely digital, randomised, controlled trial |
| title_sort | computerised cognitive training tools and online nutritional group counselling for people with mild cognitive impairment study protocol of a completely digital randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/7/e060473.full |
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