Effects of a hybrid digital cognitive–behavioural therapy for insomnia and emotion regulation in the workplace (SLEEP): study protocol for a randomised waitlist control trial
Introduction This trial tests the efficacy of implementing a hybrid digital cognitive–behavioural therapy for insomnia (dCBT-I) and emotion regulation (ER) in the workplace. The study protocol follows the SPIRIT (Standard Protocol Items: Recommendations for Intervention Trials) 2013 recommendations....
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| Format: | Article |
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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/e058062.full |
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| author | Nicole K Y Tang Caroline Meyer Talar Rita Moukhtarian Krishane Patel Carla Toro Sean Russel Guy Daly Lukasz Walasek |
| author_facet | Nicole K Y Tang Caroline Meyer Talar Rita Moukhtarian Krishane Patel Carla Toro Sean Russel Guy Daly Lukasz Walasek |
| author_sort | Nicole K Y Tang |
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| description | Introduction This trial tests the efficacy of implementing a hybrid digital cognitive–behavioural therapy for insomnia (dCBT-I) and emotion regulation (ER) in the workplace. The study protocol follows the SPIRIT (Standard Protocol Items: Recommendations for Intervention Trials) 2013 recommendations.Methods and analysis This is a mixed methods evaluation with a two-arm randomised waitlist control design of a 6-week dCBT-I+ER intervention through self-guided online platform and four videoconferencing therapy sessions. A process evaluation will examine the fidelity of delivery and experiences of the intervention. The primary outcomes are the Insomnia Severity Index, the Patient Health Questionnaire-9 and the Generalised Anxiety Disorder-7. The secondary outcomes are job productivity, job satisfaction, well-being, quality of life, self-reported (sleep diary data) and objective (actigraphy) sleep parameters, and usage of online intervention platform. Assessments take place at baseline (T0), week 8 post-treatment (T1) and week 12 postrandomisation (T2). We will recruit 156 workers with sleep and ER problems ranging from subclinical to clinical levels not engaged in treatment at the time of the trial.Ethics and dissemination Full approval was given by the University of Warwick Biomedical and Research Ethics Committee (BSREC 45/20-21). The current protocol version is 2.9_Dec21. Publication of results will inform the scientific, clinical and business communities through peer-reviewed articles, webinars, conferences and newsletters.Trial registration number ISRCTN13596153. |
| format | Article |
| id | doaj-art-c36d1988456f4d6b880eb96a6ae0342a |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
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| series | BMJ Open |
| spelling | doaj-art-c36d1988456f4d6b880eb96a6ae0342a2025-01-30T20:40:08ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-058062Effects of a hybrid digital cognitive–behavioural therapy for insomnia and emotion regulation in the workplace (SLEEP): study protocol for a randomised waitlist control trialNicole K Y Tang0Caroline Meyer1Talar Rita Moukhtarian2Krishane Patel3Carla Toro4Sean Russel5Guy Daly6Lukasz Walasek7Department of Psychology, University of Warwick, Coventry, UKWarwick Manufacturing Group, University of Warwick, Coventry, UKWarwick Medical School, University of Warwick, Coventry, UKWarwick Manufacturing Group, University of Warwick, Coventry, UKWarwick Manufacturing Group, University of Warwick, Coventry, UKHealth and Life Science Centre, Coventry University, Coventry, UKThe British University, Cairo, EgyptDepartment of Psychology, University of Warwick, Coventry, UKIntroduction This trial tests the efficacy of implementing a hybrid digital cognitive–behavioural therapy for insomnia (dCBT-I) and emotion regulation (ER) in the workplace. The study protocol follows the SPIRIT (Standard Protocol Items: Recommendations for Intervention Trials) 2013 recommendations.Methods and analysis This is a mixed methods evaluation with a two-arm randomised waitlist control design of a 6-week dCBT-I+ER intervention through self-guided online platform and four videoconferencing therapy sessions. A process evaluation will examine the fidelity of delivery and experiences of the intervention. The primary outcomes are the Insomnia Severity Index, the Patient Health Questionnaire-9 and the Generalised Anxiety Disorder-7. The secondary outcomes are job productivity, job satisfaction, well-being, quality of life, self-reported (sleep diary data) and objective (actigraphy) sleep parameters, and usage of online intervention platform. Assessments take place at baseline (T0), week 8 post-treatment (T1) and week 12 postrandomisation (T2). We will recruit 156 workers with sleep and ER problems ranging from subclinical to clinical levels not engaged in treatment at the time of the trial.Ethics and dissemination Full approval was given by the University of Warwick Biomedical and Research Ethics Committee (BSREC 45/20-21). The current protocol version is 2.9_Dec21. Publication of results will inform the scientific, clinical and business communities through peer-reviewed articles, webinars, conferences and newsletters.Trial registration number ISRCTN13596153.https://bmjopen.bmj.com/content/12/7/e058062.full |
| spellingShingle | Nicole K Y Tang Caroline Meyer Talar Rita Moukhtarian Krishane Patel Carla Toro Sean Russel Guy Daly Lukasz Walasek Effects of a hybrid digital cognitive–behavioural therapy for insomnia and emotion regulation in the workplace (SLEEP): study protocol for a randomised waitlist control trial BMJ Open |
| title | Effects of a hybrid digital cognitive–behavioural therapy for insomnia and emotion regulation in the workplace (SLEEP): study protocol for a randomised waitlist control trial |
| title_full | Effects of a hybrid digital cognitive–behavioural therapy for insomnia and emotion regulation in the workplace (SLEEP): study protocol for a randomised waitlist control trial |
| title_fullStr | Effects of a hybrid digital cognitive–behavioural therapy for insomnia and emotion regulation in the workplace (SLEEP): study protocol for a randomised waitlist control trial |
| title_full_unstemmed | Effects of a hybrid digital cognitive–behavioural therapy for insomnia and emotion regulation in the workplace (SLEEP): study protocol for a randomised waitlist control trial |
| title_short | Effects of a hybrid digital cognitive–behavioural therapy for insomnia and emotion regulation in the workplace (SLEEP): study protocol for a randomised waitlist control trial |
| title_sort | effects of a hybrid digital cognitive behavioural therapy for insomnia and emotion regulation in the workplace sleep study protocol for a randomised waitlist control trial |
| url | https://bmjopen.bmj.com/content/12/7/e058062.full |
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