- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07642479
A Theory-based Sleep Hygiene Education for Insomnia Disorder
A Theory-based Sleep Hygiene Education for Insomnia Disorder - A Non-inferiority Randomized Controlled Trial With Mixed-method Process Evaluation and Cost-effectiveness Analysis
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Wing Fai YEUNG
- Telefonní číslo: 852-27664151
- E-mail: jerry-wf.yeung@polyu.edu.hk
Studijní místa
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Hong Kong, Hongkong
- School of Nursing, The Hong Kong Polytechnic University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Aktivní komparátor: 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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Žádný zásah: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The Insomnia Severity Index (ISI)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Sleep Onset Latency Measured By Sleep Diary
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SHCI
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Studuje lékový produkt regulovaný americkým FDA
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