Efficacy of Mobile-delivered Sleep Restriction Therapy for Treatment of Insomnia Disorder: Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insomnia
- Sponsor
- Woolcock Institute of Medical Research
- Enrollment
- 558
- Locations
- 1
- Primary Endpoint
- Change in insomnia symptom severity change
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in insomnia symptom severity change
Time Frame: 8 weeks
Insomnia Severity Index (ISI) is a 7-item questionnaire used to examine overall insomnia severity. It consists of a five-point Likert type scale for each item (ranging from "no problem" = 0 to "severe problem" = 28) regarding symptoms over the past 2 weeks. Scores range from 0-28 with higher scores indicating greater insomnia symptom severity.
Secondary Outcomes
- Change in quality of life scores(8 weeks)
- Change in sleep-wake metrics(8 weeks)
- Daytime symptoms of fatigue(8 weeks)
- Treatment usability(8 weeks)
- Workforce productivity(8 Weeks)
- Change in anxiety scores(8 weeks)
- Change in depressive symptom scores(8 weeks)
- Sleep medication usage(8 weeks)