A Theory-based Sleep Hygiene Education for Insomnia Disorder

Sponsor
The Hong Kong Polytechnic University
Study ID
NCT07642479
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Sleep Hygiene Education — BEHAVIORAL
    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.
  • CBT-I Apps — BEHAVIORAL
    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.

Study Details

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 Dates

Start date
Jul 10, 2026
Status verified
Jun 2026
Primary completion
Jan 1, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
264 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.
  • No Intervention: 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.

Primary Outcome Measure

The Insomnia Severity Index (ISI) [ Time Frame: Baseline, week 6, week 12 and week 24 ]

Central Contacts

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