Insomnia
Conditions
Keywords
CBTi, Digital CBTi, Insomnia
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.
Interventions
OTHERSleepFix
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.
Three Sleep Health education modules that contain information about sleep hygiene and introduces strategies on how to reduce insomnia severity and increase sleep quality.
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The research staff and Principal Chief Investigator will not be blinded to the study as they will be managing the online study directly which will lend itself to knowing which groups participants are allocated to. All other Investigators including data analysts will be blinded throughout the course of the trial and analysis of primary and secondary outcomes. Participants will not be blinded as they will know what treatment they receive.
Intervention model description
Online (digital), two-arm, open-label randomised clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in insomnia symptom severity change | 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
| Measure | Time frame | Description |
|---|---|---|
| Daytime symptoms of fatigue | 8 weeks | The Flinders Fatigue Scale (FFS) is a 7-item self-reported instrument designed to measure the level of subjective daytime fatigue experienced over the previous two weeks. 6-items consist of a 5-point Likert type scale ranging from not at all = 0 to extremely = 4. Item 5 uses a multiple-item checklist and is scored as a sum. All items are summed with total scores ranging from 0-31 with higher scores reflecting greater fatigue. |
| Change in anxiety scores | 8 weeks | The General Anxiety Disorder-7 (GAD-7) is a 7-item self-administered scale used to assess the severity of generalised anxiety over the previous 2 weeks. It consists of a three-point Likert type scale for each item (ranging from not at all = 0 to nearly every day = 3). All items are summed with total scores ranging from 0-21 where 5, 10 and 15 indicate the cut-off scores for mild, moderate and severe anxiety, respectively. |
| Change in depressive symptom scores | 8 weeks | The Patient Health Questionnaire-8 is an 8-item self-reported measure of depressive symptoms over the past 2 weeks. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression. |
| Change in sleep-wake metrics | 8 weeks | Sleep- wake metrics will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with seven component scores derived from the responses, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0-21) where a score of 5 or more indicates poor sleep quality. |
| Treatment usability | 8 weeks | The System Usability Scale (SUS) questionnaire is a 10-item survey that examines four dimensions of usability: useful- ness, ease of use, ease of learning, and satisfaction. It is scored out of a 100; scores closer to 100 means excellent usability while scores closer to 0 means worse usability. |
| Workforce productivity | 8 Weeks | Participants will be asked short yes/no questions regarding the use of sleep medication in the previous two weeks. |
| Sleep medication usage | 8 weeks | Participants will be asked short yes/no questions regarding taking sick leaves in the previous two weeks. |
| Change in quality of life scores | 8 weeks | The EuroQol five-dimensional (EQ-5D) is a self-reported questionnaire which assesses 5 dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression and overall health. The 5 dimensions range from 1 = indicating no problem - 5 = indicating unable to/extreme problems and the overall score from 0 (worst health state imaginable) to 100 (best health state imaginable). |
Countries
Australia
Contacts
Primary ContactMatthew Rahimi, PhD
Outcome results
None listed