A Theory-based Sleep Hygiene Education for Insomnia Disorder
2026. június 7. frissítette: YEUNG Wing Fai, The Hong Kong Polytechnic University
A Theory-based Sleep Hygiene Education for Insomnia Disorder - A Non-inferiority Randomized Controlled Trial With Mixed-method Process Evaluation and Cost-effectiveness Analysis
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.
A tanulmány áttekintése
Állapot
Még nincs toborzás
Körülmények
Beavatkozás / kezelés
Részletes leírás
Insomnia is a prevalent sleep disorder associated with substantial adverse health consequences, including fatigue, irritability, and impaired daytime functioning. Although effective pharmacological (e.g., hypnotics) and psychological treatments (e.g., cognitive behavioral therapy for insomnia, CBT-I) are available, both local and international surveys indicate that fewer than 50% of individuals with insomnia seek treatment. This treatment gap underscores the need for effective non-pharmacological interventions that are both accessible and acceptable.
Sleep hygiene education (SHE) represents a potentially suitable approach to address this unmet need. SHE is an educational intervention encompassing a range of lifestyle and environmental recommendations to optimize sleep quality and duration. These include maintaining a regular sleep-wake schedule, avoiding substances such as caffeine, nicotine, and alcohol, limiting daytime napping and stimulating activities before bedtime, optimizing the sleep environment, and adopting appropriate dietary and exercise habits etc. Given its simplicity, low cost, accessibility, and ease of delivery and adoption, SHE holds promise as a non-pharmacological strategy for insomnia management.
Despite these advantages, SHE is not typically recommended as a stand-alone treatment for individuals with sleep problems, as it is often perceived to be less effective than CBT-I or mindfulness-based interventions, with consistently small effect sizes reported. However, these findings should be interpreted with caution. In many previous studies, SHE has primarily been used as a passive control condition to account for nonspecific treatment effects, thereby underexploiting its active therapeutic potential. Moving SHE beyond a simple advice-giving modality to a structured, theory-informed approach may optimize its effectiveness by ensuring its content is informative and promising. Integrating SHE with established behavior change techniques may better equip individuals with the skills needed to initiate and sustain meaningful behavioral change.
Building on our previously registered pilot-testing protocol, this study aims to evaluate the effectiveness of a theory-based SHE program integrated with behavior change techniques in a larger community sample. In addition, it remains unclear whether theory-based SHE is inferior to gold-standard interventions such as digitally delivered CBT-I. This study will also examine whether a theory-based SHE program is a cost-effective approach for reducing insomnia severity in adults with insomnia disorder compared with a CBT-I app and a no-intervention control. To address these objectives, a three-arm randomized controlled trial will be conducted to compare the relative effectiveness of these interventions.
Tanulmány típusa
Beavatkozó
Beiratkozás (Becsült)
264
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi kapcsolat
- Név: Wing Fai YEUNG
- Telefonszám: 852-27664151
- E-mail: jerry-wf.yeung@polyu.edu.hk
Tanulmányi helyek
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Hong Kong, Hong Kong
- School of Nursing, The Hong Kong Polytechnic University
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Nem
Leírás
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: Sleep Hygiene Education
Participants in this group will receive a structured six-week SHE intervention.
The intervention includes two weekly 2-hour group-based, face-to-face educational sessions (total 4 hours) conducted in a classroom at the School of Nursing, The Hong Kong Polytechnic University, followed by four weekly individualized telephone consultations lasting approximately 10 minutes each.
During the educational sessions, participants will receive education on insomnia and evidence-based sleep hygiene practices, and will develop individualized behavior change plans to support sustained implementation of sleep hygiene practices.
The subsequent telephone consultations will reinforce adherence to these plans by reviewing progress, discussing barriers, and providing tailored feedback.
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Participants in this group will receive a structured six-week SHE intervention.
The intervention includes two weekly 2-hour group-based, face-to-face educational sessions (total 4 hours) conducted in a classroom at the School of Nursing, The Hong Kong Polytechnic University, followed by four weekly individualized telephone consultations lasting approximately 10 minutes each.
During the educational sessions, participants will receive education on insomnia and evidence-based sleep hygiene practices, and will develop individualized behavior change plans to support sustained implementation of sleep hygiene practices.
The subsequent telephone consultations will reinforce adherence to these plans by reviewing progress, discussing barriers, and providing tailored feedback.
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Aktív összehasonlító: CBT-I App
Participants in this group will receive a CBT-I program consisting of six weekly modules delivered in the Chinese language through a smartphone application proACT-S.
The duration of each module is around 45 to 60 min with interactive features.
The self-help CBT-I treatment content in proACT-S is based on the Chinese translated version of a well-established CBT-I treatment manual.
The self-help CBT-I treatment content is designed to alter dysfunctional cognitive beliefs and maladaptive behaviors that perpetuate insomnia.
The self-help CBT-I treatment content CBT-I aims at changing dysfunctional cognitive beliefs and maladaptive behaviors that contribute to the maintenance of insomnia.
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Participants in this group will receive a CBT-I program consisting of six weekly modules delivered in the Chinese language through a smartphone application proACT-S.
The duration of each module is around 45 to 60 min with interactive features.
The self-help CBT-I treatment content in proACT-S is based on the Chinese translated version of a well-established CBT-I treatment manual.
The self-help CBT-I treatment content is designed to alter dysfunctional cognitive beliefs and maladaptive behaviors that perpetuate insomnia.
The self-help CBT-I treatment content CBT-I aims at changing dysfunctional cognitive beliefs and maladaptive behaviors that contribute to the maintenance of insomnia.
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Nincs beavatkozás: Waitlist Control
Participants in this group will receive no intervention from the study.
They will be provided with the same SHE program and CBT-I apps after the follow-up period.
Waitlist control is chosen as previous surveys have revealed that almost half of individuals with clinical insomnia refrain from seeking any treatment.
Therefore, the waitlist control group reflects the typical help-seeking behavior of those coping with insomnia, thus providing a more realistic comparison for our study.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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The Insomnia Severity Index (ISI)
Időkeret: Baseline, week 6, week 12 and week 24
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The Insomnia Severity Index has 7 items that measured the severity of insomnia complaints and related daytime impairments.
The total score ranges between 0 and 28, with the higher scores indicating more severe insomnia.
Total score will be used.
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Baseline, week 6, week 12 and week 24
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Sleep Onset Latency Measured By Sleep Diary
Időkeret: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
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Participants will be asked to record their daily sleeping-waking schedule using a standard sleep diary.
Sleep onset latency (SOL) is defined as the time (minutes) taken to fall asleep after going to bed.
The average value over 7 consecutive nights will be calculated.
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7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
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Wake After Sleep Onset Measured By Sleep Diary
Időkeret: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
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Participants will be asked to record their daily sleeping-waking schedule using a standard sleep diary.
Wake after sleep onset (WASO) is defined as the total time (minutes) awake after initial sleep onset during the night.
The average value over 7 consecutive nights will be calculated.
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7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
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Sleep Efficiency Measured By Sleep Diary
Időkeret: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
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Participants will be asked to record their daily sleeping-waking schedule using a standard sleep diary.
Sleep efficiency (SE) is defined as the percentage of time in bed spent asleep.
The average percentage over 7 consecutive nights will be calculated.
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7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
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Total Sleep Time Measured By Sleep Diary
Időkeret: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
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Participants will be asked to record their daily sleeping-waking schedule using a standard sleep diary.
Total sleep time (TST) is defined as the total duration (minutes) of sleep per night.
The average value over 7 consecutive nights will be calculated.
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7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
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The Hospital Anxiety and Depression Scale (HADS)
Időkeret: Baseline, week 6, week 12 and week 24
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The Hospital Anxiety and Depression Scale is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3).
It is designed to measure anxiety and depression (7 items for each subscale).
The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).
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Baseline, week 6, week 12 and week 24
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The Short-Form Six Dimensions (SF-6D)
Időkeret: Baseline, week 6, week 12 and week 24
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The Short-Form Six Dimensions (SF-6D) will be used to assess the quality of life.
The score ranges from 0 (worst quality of life) to 1 (perfect quality of life), with higher scores reflecting better overall health-related quality of life.
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Baseline, week 6, week 12 and week 24
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Sleep Onset Latency Measured By Actigraphy
Időkeret: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
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Sleep onset latency (SOL) will be objectively measured using a wrist-worn actigraphy device (GENEActiv, Activinsights, UK).
Participants will wear the device on their non-dominant wrist for 7 consecutive nights prior to each assessment time point.
SOL will be recorded in minutes, and the mean value over the 7-night period will be calculated.
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7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
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Wake After Sleep Onset Measured By Actigraphy
Időkeret: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
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Wake after sleep onset (WASO) will be objectively measured using a wrist-worn actigraphy device (GENEActiv, Activinsights, UK).
Participants will wear the device on their non-dominant wrist for 7 consecutive nights prior to each assessment time point.
WASO will be recorded in minutes, and the mean value over the 7-night period will be calculated.
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7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
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Sleep Efficiency Measured By Actigraphy
Időkeret: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
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Sleep efficiency (SE) will be objectively measured using a wrist-worn actigraphy device (GENEActiv, Activinsights, UK).
Participants will wear the device on their non-dominant wrist for 7 consecutive nights prior to each assessment time point.
SE will be expressed as a percentage, and the mean value over the 7-night period will be calculated.
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7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
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Total Sleep Time Measured By Actigraphy
Időkeret: 7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
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Total sleep time (TST) will be objectively measured using a wrist-worn actigraphy device (GENEActiv, Activinsights, UK).
Participants will wear the device on their non-dominant wrist for 7 consecutive nights prior to each assessment time point.
TST will be recorded in minutes, and the mean value over the 7-night period will be calculated.
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7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
2026. július 10.
Elsődleges befejezés (Becsült)
2028. január 1.
A tanulmány befejezése (Becsült)
2028. június 30.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. május 23.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. június 7.
Első közzététel (Tényleges)
2026. június 11.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. június 11.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. június 7.
Utolsó ellenőrzés
2026. június 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- SHCI
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