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      Cognitive-behavioural therapy (CBT) for renal fatigue (BReF): a feasibility randomised-controlled trial of CBT for the management of fatigue in haemodialysis (HD) patients

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          Abstract

          Introduction

          Fatigue is one of the most common and disabling symptoms in end-stage kidney disease, particularly among in-centre haemodialysis patients. This two-arm parallel group feasibility randomised controlled trial will determine whether a fully powered efficacy trial is achievable by examining the feasibility of recruitment, acceptability and potential benefits of a cognitive-behavioural therapy (CBT)-based intervention for fatigue among in-centre haemodialysis patients.

          Methods

          We aim to recruit 40 adult patients undergoing in-centre haemodialysis at secondary care outpatient dialysis units, who meet clinical levels of fatigue. Patients will be randomised individually (using a 1:1 ratio) to either a 4–6 weeks’ CBT-based intervention (intervention arm) or to a waiting-list control (control arm). The primary feasibility outcomes include descriptive data on numbers within each recruiting centre meeting eligibility criteria, rates of recruitment, numbers retained postrandomisation and treatment adherence. To assess the potential benefits of the cognitive-behavioural therapy for renal fatigue intervention, secondary self-report outcomes include measures of fatigue severity (Chalder Fatigue Questionnaire), fatigue-related functional impairment (Work and Social Adjustment Scale), sleep quality (Pittsburgh Sleep Quality Index), depression (Patient Health Questionnaire-9) and anxiety (Generalised Anxiety Disorder-7). Changes in fatigue perceptions (Brief Illness Perception Questionnaire), cognitive and behavioural responses to fatigue (Cognitive and Behavioural Responses to Symptoms Questionnaire), sleep hygiene behaviours (Sleep Hygiene Index) and physical activity (International Physical Activity Questionnaire–short form) will also be explored. These self-report measures will be collected at baseline and 3 months postrandomisation. Nested qualitative interviews will be conducted postintervention to explore the acceptability of the intervention and identify any areas in need of improvement. The statistician and assessor will be blinded to treatment allocation.

          Ethics and dissemination

          A National Health Service (NHS) Research Ethics Committee approved the study. Any amendments to the protocol will be submitted to the NHS Committee and study sponsor.

          Trial registration number

          ISRCTN91238019;Pre-results.

          Related collections

          Most cited references 92

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          A brief measure for assessing generalized anxiety disorder: the GAD-7.

          Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
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            The PHQ-9: validity of a brief depression severity measure.

            While considerable attention has focused on improving the detection of depression, assessment of severity is also important in guiding treatment decisions. Therefore, we examined the validity of a brief, new measure of depression severity. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ-9 was completed by 6,000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-9 depression severity increased, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and health care utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-9 score > or =10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Results were similar in the primary care and obstetrics-gynecology samples. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.
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              Physical activity questionnaires for adults: a systematic review of measurement properties.

              Many questionnaires have been developed to measure physical activity (PA), but an overview of the measurement properties of PA questionnaires is lacking. A summary of this information is useful for choosing the best questionnaire available. Therefore, the objective of this study was to evaluate and compare measurement properties of self-administered questionnaires assessing PA in adults. We searched MEDLINE, EMBASE and SportDiscus, using 'exercise', 'physical activity', 'motor activity' and 'questionnaire' as keywords. We included studies that evaluated the measurement properties of self-report questionnaires assessing PA. Article selection, data extraction and quality assessment were performed by two independent reviewers. The quality and results of the studies were evaluated using the Quality Assessment of Physical Activity Questionnaires (QAPAQ) checklist. Construct validity, reliability and responsiveness were rated as positive, negative or indeterminate, depending on the methods and results. We included 85 (versions of) questionnaires. Overall, the quality of the studies assessing measurement properties of PA questionnaires was rather poor. Information on content validity was mostly lacking. Construct validity was assessed in 76 of the questionnaires, mostly by correlations with accelerometer data, maximal oxygen uptake or activity diaries. Fifty-one questionnaires were tested for reliability. Only a few questionnaires had sufficient construct validity and reliability, but these need to be further validated. Responsiveness was studied for only two questionnaires and was poor. There is a clear lack of standardization of PA questionnaires, resulting in many variations of questionnaires. No questionnaire or type of questionnaire for assessing PA was superior and therefore could not be strongly recommended above others. In the future, more attention should be paid to the methodology of studies assessing measurement properties of PA questionnaires and the quality of reporting.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2018
                8 March 2018
                : 8
                : 3
                Affiliations
                [1 ] departmentHealth Psychology Section, Psychology Department , Institute of Psychiatry, Psychology and Neuroscience, King’s College London , London, UK
                [2 ] departmentDepartment of Renal Medicine , King’s College Hospital , London, UK
                [3 ] departmentDepartment of Renal Medicine , Lister Hospital , Stevenage, UK
                [4 ] University of Hertfordshire , Hertfordshire, UK
                Author notes
                [Correspondence to ] Federica Picariello; federica.picariello@ 123456kcl.ac.uk
                Article
                bmjopen-2017-020842
                10.1136/bmjopen-2017-020842
                5855165
                29523571
                © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

                This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

                Product
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000272, National Institute for Health Research;
                Categories
                Patient-Centred Medicine
                Protocol
                1506
                1722
                Custom metadata
                unlocked

                Medicine

                dialysis, fatigue, cognitive behavioural therapy, kidney failure, quality of life

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