App-delivered Sleep ThERapy for Older Individuals With Insomnia

Study Overview
=================
Brief Summary
-----------------
This randomised, open, parallel controlled trial aims to compare the efficacy of a digital brief behavioural therapy for insomnia (dBBTi) against online sleep health education on insomnia symptom severity in older adults aged 60 years and over. The trial will be totally online with participants recruited from the community across Australia.

Detailed Description
-----------------
Insomnia is a highly prevalent sleep disorder affecting up to 10% of the adult population and reports of over 40% in the older population. Current insomnia treatments focus heavily on symptom management with cognitive behavioural therapy for insomnia (CBTi), in both digital and face-to-face form as the recommended first-line treatment. Despite the strong evidence for digital CBTi, there are a lack of data related to older people and whether digital brief behavioural therapy is efficacious in this population. The investigators will conduct a fully online study comparing 6-weeks of digital brief behavioural therapy for insomnia (dBBTi) against online sleep health education. Participants will be recruited, screened and determined eligibility and consent will be conducted online. Thereafter, participants will be randomly allocated to either dBBTi delivered via a mobile application called SleepFix or wait-listed control. The SleepFix app delivers sleep restriction therapy using a 4 stage approach to improve sleep efficiency. The control will consist of 3 online sleep health education modules provided bi-weekly with information about sleep and sleep hygiene without any specific insomnia therapy. Participants will be recruited using social media and directed to a website to determine eligibility and then provided access to either the dBBTi (SleepFix) or the control with a link to the first online module. At baseline, all participants will complete self-reported measures of insomnia, sleep, fatigue, sleepiness , anxiety, depression, quality of life, cognition and digital health literacy. These will be repeated at follow-up at weeks 8, 16 and 26.

Official Title
-----------------
App-delivered Sleep ThERapy for Older Individuals With Insomnia (ASTEROID Study)

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Behavioral: SleepFix mobile application
* Behavioral: Sleep Health Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older adults aged ≥ 60 years Able to give informed online consent Insomnia Severity Index ≥ 10, including a score of 3 in at least one of the first three items (nocturnal symptoms). English fluency Access to a smartphone and willingness/proficiency to use a mobile app Exclusion Criteria: Shift-workers Travel to a destination with >2 hours time-difference (within 30-days) Serious medical and/or psychiatric illnesses/disorders or self-harm risk (Patient Health Questionnaire-9, item 9, 1+ score of risk of suicidal ideation) Diagnosed sleep disorders other than insomnia Regular sleep medications or sleep devices (>2 times a week over last 6 months) Currently receiving or previously received (within the last 12 months) psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT). Drive for work/operate heavy machinery

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be provided with a digital brief behavioural therapy (SleepFix app) which provides personalised sleep retraining therapy. Participants will also be provided a sleep-tracking wearable device (Fitbit) that synchronises the going to bed and getting out of bed times with the SleepFix app. Participants will complete a daily sleep diary and can modify the sleep-tracking wearable device sleep data. The program will provide an individualised sleep window of when to go and when to get out of bed. There are five stages focusing on bed timings, sleep efficiency and a maintenance phase for consolidating the new sleep pattern. The program provides information related to sleep hygiene and stimulus control. This will be available for participants for 6 weeks. An active wait-listed control of sleep health education will consist of 3 modules delivered biweekly of generalised sleep health information that could be found on the internet.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital brief behavioural therapy for insomnia<br>Participants randomised to the digital brief behavioural therapy for insomnia (SleepFix app) will be provided an unique access code to download the app. The intervention uses sleep retraining therapy to reduce excess time spent in bed and retrain sleep by matching time in bed (minimum of five and a half hours) to total sleep time. All participants in the intervention arm will also be provided a sleep-tracking wearable device (Fitbit) which will synchronised bed times (going to bed and rising) and are synchronised with the SleepFix app. Participants wil complete a daily sleep diary, rate sleep quality and mood. The intervention is provided for 6 weeks. | Behavioral: SleepFix mobile application<br>* The SleepFix app is a novel, innovative way to deliver digital brief behavioural therapy for insomnia for adults.<br>|
| Active Comparator: Sleep Health Education wait-list control<br>Participants randomised to the control group will gain access to the first Sleep Health Education module immediately following completion of baseline questionnaires. There are three modules provided bi-weekly with information about sleep health and broad details about managing sleep disturbances. Participants will receive a link to this information as each module is made available. Upon completion of the study (week 26), the control group will receive free access to the SleepFix mobile application. | Behavioral: Sleep Health Education<br>* These internet-based modules provide an active control intervention consisting of 3 modules provided bi-weekly. The participant will receive a link to this information as each module is made available. Control participants will have full access to these modules for the duration of the study. They reflect basic educational information regarding sleep health for poor sleepers that is otherwise easily accessible on the internet.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insomnia symptom severity | 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 = 4) regarding symptoms over the past 2 weeks. Scores range from 0-28 with higher scores indicating greater insomnia symptom severity. | Change score from baseline at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subjective sleep quality | Subjective sleep quality 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. | Change score from baseline at 8 weeks | 
| Change in sleep onset latency | Sleep onset latency will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with a total score range of 0 to 21 with scores greater than 5 indicating poor sleep quality. A single item will be used to assess sleep onset latency over the last 2 weeks. | Change score from baseline at 8 weeks | 
| Change in wake after sleep onset | Wake after sleep onset will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with a total score range of 0 to 21 with scores greater than 5 indicating poor sleep quality. A single item will be used to assess wake after sleep onset over the last 2 weeks. | Change score from baseline at 8 weeks | 
| Change in total sleep time | Total sleep time will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with a total score range of 0 to 21 with scores greater than 5 indicating poor sleep quality. A single item will be used to assess total sleep time over the last 2 weeks. | Change score from baseline at 8 weeks | 
| Change in fatigue | 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 score from baseline at 8 weeks | 
| Change in daytime sleepiness | The Epworth Sleepiness Scale (ESS) is an 8-item self-reported questionnaire that provides a rating of general sleepiness over the last 2 weeks using a 4-point likert scale from would never dose = 0 to high chance of dozing = 3. All items are summed with total scores ranging from 0-26 where scores >10 indicating above-average daytime sleepiness. | Change score from baseline at 8 weeks | 
| Change in quality of Life | 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). | Change score from baseline at 8 weeks | 
| Change in depressive symptoms | The Patient Health Questionnaire-9 is a 9-item self-reported measure of depressive symptoms over the past 2 weeks. Scores for each question (Likert type scale not at all = 0 to nearly every day = 3) sum to a total score out of 27 with higher scores reflecting severe depressive symptoms. | Change score from baseline at 8 weeks | 
| Change in anxiety | 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 score from baseline at 8 weeks | 
| Change in self-reported cognition | The British Columbia Cognitive Complaints Inventory (BC-CCI) is a 6-item tool to assess self-perceived cognition. It explores any perceived problems associated with cognition, memory, expressing thoughts, word finding, slow thinking, and difficulty solving problems in reflection of the last 7 days. Answers for each question range from 0 (= not at all) to 3 (= Very much). Scores are summed to a total out of 18 that reflects the cognitive complaint severity. | Change score from baseline at 8 weeks | 
| Impact of engagement on therapeutic effect | To determine if there is a relationship between therapeutic outcome (Insomnia Severity Index, ISI) and adherence to therapy (prescribed bed-time compared to time in bed) | Baseline, week 8 | 
| The effect of baseline digital health literacy on therapy efficacy | Digital health literacy will be assessed using the eHEALS Literacy Scale (eHEALS) which is an 8-item, 5-point Likert-type questionnaire that measures a participant's perception of, and ability toward electronic health information. Responses range from strongly disagree =1, to strongly agree = 5. Total scores are summed to range from 8 to 40 where lower scores indicate lower self-reported digital health literacy. The moderating effect of the baseline digital health literacy on therapeutic outcomes (ISI scores) and engagement (number of daily sleep diary entries) will be assessed. | Baseline, week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep, digital, older people, brief behavioural therapy