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

ConditionInsomnia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWoolcock Institute of Medical Research

About this 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.

Eligibility criteria

Qualifiers

Adults aged ≥ 18 years

Able to give informed online consent

Insomnia Severity Index ≥ 12

English fluency

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • SleepFix
  • Sleep health Education modules

Treatment groups

558 Participants
are divided into 2 treatment groups