A Theory-based Sleep Hygiene Education for Insomnia Disorder
Starting soon · Not applicable
Conditions studied: Insomnia, Adults
In brief
Insomnia is a prevalent sleep disorder associated with numerous adverse health outcomes, including fatigue, irritability, and impaired daytime functioning. Despite the availability of effective pharmacological and psychological treatments, relatively few individuals with insomnia seek professional help, highlighting the need for accessible and acceptable non-pharmacological interventions. Sleep hygiene education (SHE) has the potential to address this gap due to its simplicity, low cost, and ease of self-administration. Building on our previously registered pilot-testing protocol, this study aims to examine the effectiveness of a theory-based SHE program integrated with behavior change techniques in a larger community population. Furthermore, it remains unclear whether theory-based SHE is inferior to gold-standard interventions such as cognitive behavioral therapy for insomnia (CBT-I) delivered via digital applications. Therefore, this study will also compare the effectiveness of theory-based SHE with a CBT-I app using a three-arm randomized controlled trial design.
Key facts
- Study ID
- NCT07642479
- Run by
- The Hong Kong Polytechnic University
- People needed
- 264
- Starts
- 2026-07-10
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2026-06-11
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Hong Kong residents
- Ethnic Chinese aged 18-65 years with the ability to communicate in Cantonese or Putonghua
- Who fulfil the DSM-5 diagnostic criteria for insomnia disorder according to a validated diagnostic tool, the Brief Insomnia Questionnaire
- Scored at least 10 points in the Insomnia Severity Index
- Willing to give informed consent
You may not qualify if…
- Any current diagnosis fulfilling the DSM-IV criteria of a major depressive disorder, generalized anxiety disorders, post-traumatic stress disorder, panic disorder, substance use disorders, or schizophrenia as screened using the Chinese version of the Structured Clinical Interview for DSM-IV
- Other sleep disorders, including circadian rhythm disorder, narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) as determined based on cut-off scores (≥ 7 on narcolepsy; ≥ 8 on circadian rhythm disorder; ≥ 15 on OSA; ≥ 7 on RLS/PLMD) using SLEEP-50. If in doubt, subjects will be referred to our team psychiatrist (KF Chung) for further assessment
- Any current medical conditions or side-effects of medication that are contributing significantly to the subject's insomnia
- Taking medications or currently participating in other psychotherapies for insomnia or other psychiatric disorders
- Impaired cognitive functioning (<22 points in HK-MoCA) or with difficulty in giving consent or understanding instructions
- Pregnant
- Shift work
Where it is running
- School of Nursing, The Hong Kong Polytechnic University — Hong Kong, Hong Kong
Full record on ClinicalTrials.gov
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