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      Effects of digital Cognitive Behavioural Therapy for Insomnia on cognitive function: study protocol for a randomised controlled trial

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          Abstract

          Background

          The daytime effects of insomnia pose a significant burden to patients and drive treatment seeking. In addition to subjective deficits, meta-analytic data show that patients experience reliable objective impairments across several cognitive domains. While Cognitive Behavioural Therapy for Insomnia (CBT-I) is an effective and scalable treatment, we know little about its impact upon cognitive function. Trials of CBT-I have typically used proxy measures for cognitive functioning, such as fatigue or work performance scales, and no study has assessed self-reported impairment in cognitive function as a primary outcome. Moreover, only a small number of studies have assessed objective cognitive performance, pre-to-post CBT-I, with mixed results. This study specifically aims to (1) investigate the impact of CBT-I on cognitive functioning, assessed through both self-reported impairment and objective performance measures, and (2) examine whether change in sleep mediates this impact.

          Methods/design

          We propose a randomised controlled trial of 404 community participants meeting criteria for Insomnia Disorder. In the DISCO trial ( D efining the I mpact of improved S leep on CO gnitive function (DISCO)) participants will be randomised to digital automated CBT-I delivered by a web and/or mobile platform (in addition to treatment as usual (TAU)) or to a wait-list control (in addition to TAU). Online assessments will take place at 0 (baseline), 10 (post-treatment), and 24 (follow-up) weeks. At week 25, all participants allocated to the wait-list group will be offered digital CBT-I, at which point the controlled element of the trial will be complete. The primary outcome is self-reported cognitive impairment at post-treatment (10 weeks). Secondary outcomes include objective cognitive performance, insomnia severity, sleepiness, fatigue, and self-reported cognitive failures and emotional distress. All main analyses will be carried out on completion of follow-up assessments and will be based on the intention-to-treat principle. Further analyses will determine to what extent observed changes in self-reported cognitive impairment and objective cognitive performance are mediated by changes in sleep. The trial is supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC) based at Oxford University Hospitals NHS Trust and University of Oxford, and by the NIHR Oxford Health BRC.

          Discussion

          This study will be the first large-scale examination of the impact of digital CBT-I on self-reported cognitive impairment and objective cognitive performance.

          Trial registration

          ISRCTN, ID: ISRCTN89237370. Registered on 17 October 2016.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s13063-017-2012-6) contains supplementary material, which is available to authorized users.

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          Most cited references 31

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          Diagnostic and Statistical Manual of Mental Disorders, 5th ed.

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            The Cognitive Failures Questionnaire (CFQ) and its correlates.

            This paper describes a questionnaire measure of self-reported failures in perception, memory, and motor function. Responses to all questions tend to be positively correlated, and the whole questionnaire correlates with other recent measures of self-reported deficit in memory, absent-mindedness, or slips of action. The questionnaire is however only weakly correlated with indices of social desirability set or of neuroticism. It is significantly correlated with ratings of the respondent by his or her spouse, and accordingly does have some external significance rather than purely private opinion of the self. The score is reasonably stable over long periods, to about the same extent as traditional measures of trait rather than state. Furthermore, it has not thus far been found to change in persons exposed to life-stresses. However, it does frequently correlate with the number of current psychiatric symptoms reported by the same person on the MHQ; and in one study it has been found that CFQ predicts subsequent MHQ in persons who work at a stressful job in the interval. It does not do so in those who work in a less stressful environment. The most plausible view is that cognitive failure makes a person vulnerable to showing bad effects of stress, rather than itself resulting from stress.
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              Recommendations for a standard research assessment of insomnia.

              To present expert consensus recommendations for a standard set of research assessments in insomnia, reporting standards for these assessments, and recommendations for future research. N/A. N/A. An expert panel of 25 researchers reviewed the available literature on insomnia research assessments. Preliminary recommendations were reviewed and discussed at a meeting on March 10-11, 2005. These recommendations were further refined during writing of the current paper. The resulting key recommendations for standard research assessment of insomnia disorders include definitions/diagnosis of insomnia and comorbid conditions; measures of sleep and insomnia, including qualitative insomnia measures, diary, polysomnography, and actigraphy; and measures of the waking correlates and consequences of insomnia disorders, such as fatigue, sleepiness, mood, performance, and quality of life. Adoption of a standard research assessment of insomnia disorders will facilitate comparisons among different studies and advance the state of knowledge. These recommendations are not intended to be static but must be periodically revised to accommodate further developments and evidence in the field.
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                Author and article information

                Contributors
                simon.kyle@ndcn.ox.ac.uk
                madeleine.hurry@ndcn.ox.ac.uk
                richard.emsley@manchester.ac.uk
                annemarie.luik@ndcn.ox.ac.uk
                ximena.omlin@ndcn.ox.ac.uk
                kai.spiegelhalder@uniklinik-freiburg.de
                colin.espie@ndcn.ox.ac.uk
                claire.sexton@psych.ox.ac.uk
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                17 June 2017
                17 June 2017
                2017
                : 18
                Affiliations
                [1 ]ISNI 0000 0004 1936 8948, GRID grid.4991.5, Nuffield Department of Clinical Neurosciences, Sleep and Circadian Neuroscience Institute, , University of Oxford, Sir William Dunn School of Pathology, ; South Parks Road, Oxford, OX1 3RE UK
                [2 ]ISNI 0000 0004 1936 8948, GRID grid.4991.5, Oxford Nuffield Department of Clinical Neurosciences, , Centre for Functional Magnetic Resonance Imaging of the Brain (FMRIB Centre), University of Oxford, ; Oxford, UK
                [3 ]ISNI 0000000121662407, GRID grid.5379.8, Centre for Biostatistics, School of Health Sciences, , The University of Manchester, Manchester Academic Health Science Centre, ; Manchester, UK
                [4 ]Big Health Ltd., London, UK
                [5 ]GRID grid.5963.9, Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, , Faculty of Medicine, University of Freiburg, ; Freiburg, Germany
                Article
                2012
                10.1186/s13063-017-2012-6
                5474001
                28623947
                © The Author(s). 2017

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000272, National Institute for Health Research;
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2017

                Medicine

                insomnia, sleep, cognitive impairment, cognitive behavioural therapy, internet

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