Effects of e-aid cognitive behavioural therapy for insomnia (eCBTI) to prevent the transition from episodic insomnia to persistent insomnia: study protocol for a randomised controlled trial
Introduction Previous evidence suggested that online self-guided sleep intervention is efficacious in improving treatment outcomes in patients with persistent insomnia. However, research on online sleep interventions targeting episodic insomnia has been scarce. This study aims to evaluate the effect...
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BMJ Publishing Group
2019-11-01
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| author | Jihui Zhang Yuan Yang Xian Luo Dhirendra Paudel Shirley Xin Li |
| author_facet | Jihui Zhang Yuan Yang Xian Luo Dhirendra Paudel Shirley Xin Li |
| author_sort | Jihui Zhang |
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| description | Introduction Previous evidence suggested that online self-guided sleep intervention is efficacious in improving treatment outcomes in patients with persistent insomnia. However, research on online sleep interventions targeting episodic insomnia has been scarce. This study aims to evaluate the effectiveness of brief e-aid cognitive behavioural therapy for insomnia (eCBTI) in preventing transition from episodic insomnia to persistent insomnia.Methods and analysis This is a pragmatic two-arm multicentre, randomised controlled trial comparing eCBTI with treatment as usual (TAU) in outpatients. Two hundred patients with episodic insomnia (as defined by DSM-5) will be recruited. Patients will be randomly assigned to receive 1 week eCBTI via a Smartphone application, or to receive TAU. Treatment effects will be assessed at 1 week and 3 months after intervention. The primary outcome of the study, whether the eCBTI program is sufficient in preventing transition from short-term to persistent insomnia, is measured by the Insomnia Severity Index. Secondary outcome measurements include the Dysfunctional Beliefs and Attitudes about Sleep Scale, Ford Insomnia Response to Stress Test, Sleep Hygiene and Practices Scale, Pre-sleep Arousal Scale and Epworth Sleepiness Scale. Additionally, the Hospital Anxiety and Depression Scale and the Short-Form 12-Item Health Survey will be used for measurement of mood symptoms and quality of life.Ethics and dissemination Ethical approval for the study has been obtained from the Ethics Committee of Southern Medical University (reference number: NFEC-2017–131). The results of the investigation will be published in scientific papers. The data from the investigation will be made available online if necessary.Trial registration NCT03302455 (clinicaltrials.gov). Date of registration: October 5, 2017. |
| format | Article |
| id | doaj-art-b82fe680cbfa4e2db735e2d2047cc105 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-11-01 |
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| spelling | doaj-art-b82fe680cbfa4e2db735e2d2047cc1052024-11-29T04:30:10ZengBMJ Publishing GroupBMJ Open2044-60552019-11-0191110.1136/bmjopen-2019-033457Effects of e-aid cognitive behavioural therapy for insomnia (eCBTI) to prevent the transition from episodic insomnia to persistent insomnia: study protocol for a randomised controlled trialJihui Zhang0Yuan Yang1Xian Luo2Dhirendra Paudel3Shirley Xin Li4Center for Sleep and Circadian Medicine, Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, Guangdong, ChinaGuangdong Mental Health Center, Guangdong Provincial People`s Hospital (Guangdong Academy of Medical Sciences), Guangzhou, Guangdong, ChinaDepartment of Psychiatry, Southern Medical University Nanfang Hospital, Guangzhou, ChinaDepartment of Psychiatry, Southern Medical University Nanfang Hospital, Guangzhou, ChinaDepartment of Psychology, University of Hong Kong, Hong Kong, ChinaIntroduction Previous evidence suggested that online self-guided sleep intervention is efficacious in improving treatment outcomes in patients with persistent insomnia. However, research on online sleep interventions targeting episodic insomnia has been scarce. This study aims to evaluate the effectiveness of brief e-aid cognitive behavioural therapy for insomnia (eCBTI) in preventing transition from episodic insomnia to persistent insomnia.Methods and analysis This is a pragmatic two-arm multicentre, randomised controlled trial comparing eCBTI with treatment as usual (TAU) in outpatients. Two hundred patients with episodic insomnia (as defined by DSM-5) will be recruited. Patients will be randomly assigned to receive 1 week eCBTI via a Smartphone application, or to receive TAU. Treatment effects will be assessed at 1 week and 3 months after intervention. The primary outcome of the study, whether the eCBTI program is sufficient in preventing transition from short-term to persistent insomnia, is measured by the Insomnia Severity Index. Secondary outcome measurements include the Dysfunctional Beliefs and Attitudes about Sleep Scale, Ford Insomnia Response to Stress Test, Sleep Hygiene and Practices Scale, Pre-sleep Arousal Scale and Epworth Sleepiness Scale. Additionally, the Hospital Anxiety and Depression Scale and the Short-Form 12-Item Health Survey will be used for measurement of mood symptoms and quality of life.Ethics and dissemination Ethical approval for the study has been obtained from the Ethics Committee of Southern Medical University (reference number: NFEC-2017–131). The results of the investigation will be published in scientific papers. The data from the investigation will be made available online if necessary.Trial registration NCT03302455 (clinicaltrials.gov). Date of registration: October 5, 2017.https://bmjopen.bmj.com/content/9/11/e033457.full |
| spellingShingle | Jihui Zhang Yuan Yang Xian Luo Dhirendra Paudel Shirley Xin Li Effects of e-aid cognitive behavioural therapy for insomnia (eCBTI) to prevent the transition from episodic insomnia to persistent insomnia: study protocol for a randomised controlled trial BMJ Open |
| title | Effects of e-aid cognitive behavioural therapy for insomnia (eCBTI) to prevent the transition from episodic insomnia to persistent insomnia: study protocol for a randomised controlled trial |
| title_full | Effects of e-aid cognitive behavioural therapy for insomnia (eCBTI) to prevent the transition from episodic insomnia to persistent insomnia: study protocol for a randomised controlled trial |
| title_fullStr | Effects of e-aid cognitive behavioural therapy for insomnia (eCBTI) to prevent the transition from episodic insomnia to persistent insomnia: study protocol for a randomised controlled trial |
| title_full_unstemmed | Effects of e-aid cognitive behavioural therapy for insomnia (eCBTI) to prevent the transition from episodic insomnia to persistent insomnia: study protocol for a randomised controlled trial |
| title_short | Effects of e-aid cognitive behavioural therapy for insomnia (eCBTI) to prevent the transition from episodic insomnia to persistent insomnia: study protocol for a randomised controlled trial |
| title_sort | effects of e aid cognitive behavioural therapy for insomnia ecbti to prevent the transition from episodic insomnia to persistent insomnia study protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/9/11/e033457.full |
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