A Theory-based Sleep Hygiene Education for Insomnia Disorder

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for ethnic Chinese adults living in Hong Kong who have insomnia disorder. It compares sleep habit education, a CBT-I phone app and a waiting list.

Életkor

18 to 65 years

Nem

All sexes

A betegség stádiuma

Insomnia disorder by DSM-5 criteria on the Brief Insomnia Questionnaire, with a score of at least 10 points on the Insomnia Severity Index.

Korábbi kezelés

People cannot join if they take medicines or have other talk therapy for insomnia or other mental health conditions.

A részvétel fő kizáró okai

• Current major depression, generalized anxiety, PTSD, panic disorder, substance use disorder or schizophrenia
• Other sleep disorders, such as sleep apnoea, narcolepsy, circadian rhythm disorder or restless legs
• Medical conditions or medicine side effects that strongly add to the insomnia
• Problems with thinking or memory (under 22 points on HK-MoCA), or trouble giving consent
• Being pregnant or doing shift work

A regiszter feltételei, szó szerint

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

• 18 és 65 év között vagy?IgenNem

Mit akar kideríteni a vizsgálat

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 vizsgálat 3 csoportja

• Sleep Hygiene EducationA vizsgált kezelés

  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 AppMár használt kezelés, összehasonlításként

  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.

  Kezelés: CBT-I Apps

• Waitlist ControlNincs vizsgálati kezelés, összehasonlításként

  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.