Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial

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 adults with insomnia who have a smartphone. It compares a sleep restriction therapy app with online sleep health lessons, all done online.

Életkor

18 years and older

Nem

All sexes

A betegség stádiuma

Insomnia with an Insomnia Severity Index score of 12 or more

Korábbi kezelés

People currently getting Cognitive Behavioural Therapy for insomnia (CBT-i) cannot join.

A részvétel fő kizáró okai

• Shift workers with at least 2 night shifts a week between 8 pm and 8 am
• Serious medical or mental illness
• Other known or suspected sleep disorders, such as REM Sleep Behaviour Disorder or Restless Leg Syndrome
• Operators of machinery that needs high alertness, such as truck drivers, train drivers or pilots
• Pregnant women

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

The "SleepFix Study" is a clinical trial designed to evaluate the efficacy of mobile-delivered sleep restriction therapy (dBTi) in comparison to digital sleep health education (control) for treating insomnia disorder in adults aged 18 and above. The study is conducted entirely online, with 558 participants (279 in each group) and aims to determine the impact of the interventions on insomnia symptom severity, sleep metrics, subjective sleep quality, fatigue, anxiety, depressive symptoms, quality of life, medication usage, and workforce productivity.

A vizsgálat 2 csoportja

• Intervention - SleepFixA vizsgált kezelés

  Participants will get access to a webpage and video which will show participants information about the dBTi SleepFix mobile application. This information will explain application download, usage concepts and frequently asked questions (FAQ). The intervention webpage will continue to be available for the participants throughout the intervention period for reference if necessary and be only accessible by this group. Participants will also be sent an email and/or text message with a direct link to iOS or Google play app stores to download the "SleepFix" mobile application. They will be provided a unique alphanumeric access code and instructed to enter this code to access the app program. Participants will be able to commence therapy immediately upon app onboarding.

  Kezelés: SleepFix

• Control - Sleep Health Education modulesMár használt kezelés, összehasonlításként

  The participant will receive a link to three Sleep Health Education modules bi-weekly. All participants in the control group will gain access to the SleepFix mobile application upon completing their control period.

  Kezelés: Sleep health Education modules