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

Study Overview
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Brief Summary
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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.

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

Conditions
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Insomnia

Intervention / Treatment
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* Other: SleepFix
* Other: Sleep health Education modules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Online (digital), two-arm, open-label randomised clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention - SleepFix<br>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. | Other: SleepFix<br>* SleepFix mobile application uses Sleep Retraining Therapy (SRT) which aims to reduce excess time spent in bed and reset sleep by matching time in bed (minimum of five and a half hours) to total sleep time (TST). There are four stages to the dBTi application and participants will progress based on completion of each stage. At the commencement of SleepFix application, participants enter sleep and bedtime data into the smartphone application for baseline referencing. These data are used to determine the sleep therapy based on a pre-determined algorithm that calculates optimum sleep efficiency.<br>|
| Active Comparator: Control - Sleep Health Education modules<br>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. | Other: Sleep health Education modules<br>* Three Sleep Health education modules that contain information about sleep hygiene and introduces strategies on how to reduce insomnia severity and increase sleep quality.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia symptom severity | Insomnia symptom severity will be measure by Insomnia Severity Index (ISI) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep-wake metrics | Sleep onset latency, wake after sleep onset, total sleep time, sleep efficiency will be measured using a sleep diary and subjective sleep quality using the The Pittsburgh Sleep Quality Index questionnaire. | 8 weeks | 
| Daytime symptoms of fatigue | Daytime symptoms of fatigue with Flinders Fatigue Scale questionnaire | 8 weeks | 
| Anxiety | The General Anxiety Disorder-7 will be used to measure anxiety levels | 8 weeks | 
| Depression | The Patient Health Questionnaire-8 is a brief questionnaire used to assess the severity of depression | 8 weeks | 
| Quality of life | The EuroQol five-dimensional (EQ-5D) will be used to measure quality of life. EQ-5D is a well-validated, generic instrument for measuring health related quality of life. | 8 weeks | 
| Treatment usability | The USE questionnaire is a survey that examines four dimensions of usability: useful- ness, ease of use, ease of learning, and satisfaction. | 8 weeks | 
| Workforce productivity | Participants will be asked short yes/no questions regarding the use of sleep medication in the previous two weeks. | 8 Weeks | 
| Sleep medication usage | Participants will be asked short yes/no questions regarding taking sick leaves in the previous two weeks. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBTi, Digital CBTi, Insomnia