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
Open accessAbstract
INTRODUCTION: Previous evidence suggested that online self-guided sleep intervention is efficacious in improving treatment outcomes in patients with chronic insomnia [corrected]. However, research on online sleep interventions targeting acute insomnia [corrected] has been scarce. This study aims to evaluate the effectiveness of brief e-aid cognitive behavioural therapy for insomnia (eCBTI) in preventing transition from acute insomnia to chronic insomnia [corrected]. 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 acute insomnia [corrected] (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 chronic insomnia [corrected], 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.
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eCBTi interventions are considered low-risk psychotherapeutic interventions.
“As such, also in previous studies CBTi interventions are considered as low-risk psychotherapeutic interventions (87, 92, 153).”
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- Authors
- Yang, Y., Luo, X., Paudel, D., Zhang, J., Li, S. X., & Zhang, B.
- Affiliations
- Nanfang Hospital (CN)
- Chinese University of Hong Kong (HK)
- University of Hong Kong (HK)
- Corresponding author
- Zhang, Bin
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2019-11
- Volume
- 9
- Issue
- 11
- Pages
- e033457
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC6886949
- OpenAlex
- W2983407738
- Cited by
- 17
- References
- 39
- Citations by year
- 2025: 2 · 2024: 5 · 2023: 1 · 2022: 2 · 2021: 3 · 2020: 4
- FWCI
- 2.64
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ Open (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- Innovation Item of Guangdong Provincial Department of Education (2018A043442)
- Key Item of Guangzhou bureau of education (2019KC106)
- President Foundation of Nanfang Hospital (2017L001)
- Project of Guangzhou Philosophy and Society Development (2018GZGJ58)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
- Keywords
- cognitive behavioral therapy for insomnia, mobile application, acute insomnia, insomnia prevention, self-guided intervention, sleep hygiene, dysfunctional beliefs about sleep, pre-sleep arousal, sleepiness, anxiety and depression, quality of life
- MeSH terms
- Anxiety, Depression, Humans, Sleep Initiation and Maintenance Disorders, Psychiatric Status Rating Scales, Quality of Life, Sleep, Time Factors, Multicenter Studies as Topic, Cognitive Behavioral Therapy, Treatment Outcome, Internet, Pragmatic Clinical Trials as Topic
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