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

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

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.

Inclusion Criteria:

• Adults aged ≥ 18 years
• Able to give informed online consent
• Insomnia Severity Index ≥ 12
• English fluency
• Access to a smartphone and willingness/proficiency to use a mobile application

Exclusion Criteria:

• Shift-workers (at least 2 night shifts a week between the hours of 8 pm to 8 am)
• Serious medical and/or psychiatric illnesses/disorders
• Previously diagnosed or suspected/high-risk of undiagnosed sleep disorders (e.g. REM Sleep Behaviour Disorder, Restless Leg Syndrome
• Currently receiving Cognitive Behavioural Therapy for insomnia (CBT-i)
• Operators of machinery that require high alertness (e.g. truck drivers, train drivers, pilots, etc)
• Pregnant women