A Theory-based Sleep Hygiene Education for Insomnia Disorder

NCT07642479 | Not Yet Recruiting

• 1 other identifier: SHCI
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia; Adults

Keywords

Insomnia; Sleep hygiene education; A non-inferiority randomized controlled trial; CBT-I apps; Adults

Outcome Measures

Primary Outcomes (1)

• The Insomnia Severity Index (ISI)

  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.

  Baseline, week 6, week 12 and week 24

Secondary Outcomes (10)

• Sleep Onset Latency Measured By Sleep Diary

  7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)

• Wake After Sleep Onset Measured By Sleep Diary

  7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)

• Sleep Efficiency Measured By Sleep Diary

  7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)

• Total Sleep Time Measured By Sleep Diary

  7 consecutive nights before each assessment time point (i.e., baseline, week 6, week 12, and week 24)

• The Hospital Anxiety and Depression Scale (HADS)

  Baseline, week 6, week 12 and week 24

Study Arms (3)

Sleep Hygiene Education

EXPERIMENTAL

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.

Behavioral: Sleep Hygiene Education

CBT-I App

ACTIVE COMPARATOR

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.

Behavioral: CBT-I Apps

Waitlist Control

NO INTERVENTION

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.

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.

Sleep Hygiene Education

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.

CBT-I App

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Wing Fai YEUNG

CONTACT

852-27664151; jerry-wf.yeung@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

HK (1)