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Trial registered on ANZCTR


Registration number
ACTRN12617000575336
Ethics application status
Approved
Date submitted
7/04/2017
Date registered
24/04/2017
Date last updated
21/01/2019
Date data sharing statement initially provided
21/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An open evaluation trial of the iSleepWell digital health program for insomnia and stress-related symptoms.
Scientific title
An open evaluation trial of the iSleepWell digital health program, offered through My Digital Health, for reducing insomnia, and related stress, anxiety and depression, in adults with insomnia symptoms.
Secondary ID [1] 291126 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 301954 0
Stress 302202 0
Anxiety 302203 0
Depressive symptoms 302204 0
Condition category
Condition code
Mental Health 301606 301606 0 0
Other mental health disorders
Mental Health 302373 302373 0 0
Anxiety
Mental Health 302374 302374 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A cognitive behavioural and biopsychosocially-based digital health program for decreasing symptoms of insomnia symptoms, as well as stress, depressive and anxiety symptoms (called iSleepWell), will be evaluated using a quasi-experimental trial design.

iSleepWell is a self-help digital health program designed to provide people with information and strategies to address their insomnia symptoms primarily, as well as stress, anxiety and depressive symptoms. iSleepWell contains five ‘core’ modules, plus an Introduction module, delivered over 7 weeks.

The five core iSleepWell digital health modules are:

1. Increasing Biological Flexibility: Discusses the effects of stress on sleep, sleep and the brain, and how to increase biological flexibility (e.g., stress reduction and relaxation techniques).
2. Increasing Sleep Flexibility: Looks at the techniques that can assist in improving sleep (stimulus control, sleep hygiene and sleep restriction).
3. Increasing Thinking Flexibility: Looks at how thinking can influence sleep and the techniques to improve thinking (e.g., identifying and challenging unhelpful thoughts, managing worry and rumination).
4. Increasing Wellness Flexibility: Looks at positive affect and strategies to increase wellness (e.g., self soothing, loving kindness, social connectedness).
5. Staying On Track: Looks back over the program, progress reflection and relapse prevention activities.

Each module will take approximately 25 minutes to complete. In addition, in order to reinforce the module-based information, there are 30 minutes of offline activities each week. Offline activities involve applying the techniques discussed in each module such as self-monitoring sleep, applying the stimulus control and sleep hygiene rules, monitoring thoughts and undertaking a stress reduction and wellness increasing strategy. Participants will also receive automated emails (e.g., remind them to log on, to complete their daily mood and lifestyle events survey, when to complete during, post, and follow-up questionnaires). At the beginning of each new module, participants will be asked several questions to help gauge their progress.

A 'stage release' design has been employed so that program modules are released sequentially, but at the pace that each participant is most comfortable with over the 7 weeks. However, we do recommend participants aim for one module per week (with Module 2 spanning over 2 weeks). Modules include text, graphics, audio, video, editable forms, interactive games and downloads. Modules can be accessible via web, mobile or tablet devices.

The iSleepWell program is housed within the participant's ‘My Digital Health’ dashboard. My Digital Health is the parent platform that houses a variety of digital health programs. Via the participant’s dashboard, they are able to access several resources. This includes: My Dashboard, My Inbox, My Daily Monitoring, My Progress Graphs, My Timeline, My Profile and My Tutorial. It also includes a ‘Connect to Practitioner’ request button. If clicked, an Australian-based participant can request that we add their healthcare practitioner to their My Digital Health account. If the healthcare practitioner consents to participate, the healthcare practitioner is then digitally connected to the participant’s My Digital Health account.

Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 2, 4, 6) assessments, post-intervention assessment (Week 8) and a 1 and 3-month follow-up assessment (Week 12 & Week 20 respectively). While the ‘during’, post-intervention and follow up assessments are scheduled, participants will not be able to access the iSleepWell program until they have completed the scheduled assessments (or after the expiry time to complete the scheduled assessment has lapsed). Participants will retain access to the program until Week 28 (8 weeks past the 3-month follow-up assessment).

Participant engagement with the program will be obtained through by passive analytic data (e.g., what pages / modules they visited / used and when), as well as reviewing the module review questions submitted, completion of daily self-monitoring survey and the scheduled intervention assessments. Participating healthcare practitioners may be invited to provide feedback about their digital connection experience.
Intervention code [1] 297110 0
Treatment: Other
Intervention code [2] 297111 0
Behaviour
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301009 0
Insomnia symptoms using the ISI
Timepoint [1] 301009 0
Pre intervention (Week 0), during intervention (Week 2, 4, 6), post intervention (Week 8) and at the 1 (Week 12) and 3 month (Week 20) follow-up assessment.
Secondary outcome [1] 331427 0
Depressive symptoms using the PHQ9
Timepoint [1] 331427 0
Pre intervention, during intervention, post intervention and at the 1 and 3 month follow-up assessment.
Secondary outcome [2] 331428 0
Anxiety symptoms using the GAD7
Timepoint [2] 331428 0
Pre intervention, during intervention, post intervention and at the 1 and 3 month follow-up assessment.
Secondary outcome [3] 331429 0
Psychological distress symptoms using the K10
Timepoint [3] 331429 0
Pre intervention, post intervention and at the 1 and 3 month follow-up assessment.
Secondary outcome [4] 331430 0
Emotional regulation using the DERS
Timepoint [4] 331430 0
Pre intervention, post and 1 and 3 month follow-up
Secondary outcome [5] 331431 0
Mental wellness using the MHC-SF
Timepoint [5] 331431 0
Pre intervention, post and 1 and 3 month follow-up
Secondary outcome [6] 331432 0
Optimism using the LOT-R
Timepoint [6] 331432 0
Pre intervention, post and 1 and 3 month follow-up
Secondary outcome [7] 331433 0
Quality of life using the EQ-5D
Timepoint [7] 331433 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [8] 331434 0
Affective style using the ASQ
Timepoint [8] 331434 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [9] 331436 0
Time perception using the TDT (Time Dilation Test - self-developed)
Timepoint [9] 331436 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [10] 331437 0
Treatment credibility using the TCS
Timepoint [10] 331437 0
Pre intervention
Secondary outcome [11] 331438 0
Personality traits using the TIPI
Timepoint [11] 331438 0
Pre intervention
Secondary outcome [12] 331439 0
Treatment satisfaction, including engagement, will be measured using the TSQ
Timepoint [12] 331439 0
Post intervention
Secondary outcome [13] 331440 0
Physical activity levels using single item questions (self developed)
Timepoint [13] 331440 0
Pre-intervention, post and 1 and 3 month follow-up
Secondary outcome [14] 334070 0
Social Connectedness Rating question using a 5 point scale (self developed)
Timepoint [14] 334070 0
Pre, post and 1 and 3 month follow up
Secondary outcome [15] 334071 0
Alcohol consumption levels (self-developed questions) and followed up with CAGE-AID questions if high alcohol consumption is indicated
Timepoint [15] 334071 0
Pre, post and 1 and 3 month follow up
Secondary outcome [16] 334072 0
Drug use (self-developed questions) and followed up with CAGE-AID questions if high use of drugs is indicated.
Timepoint [16] 334072 0
Pre, post and 1 and 3 month follow up
Secondary outcome [17] 334073 0
Chronic physical illness diagnosis questions (self developed)
Timepoint [17] 334073 0
Pre intervention
Secondary outcome [18] 334074 0
Mental health condition diagnosis questions (self developed)
Timepoint [18] 334074 0
Pre intervention
Secondary outcome [19] 334075 0
Current use of prescribed medication(s) question (self-developed)
Timepoint [19] 334075 0
Pre, post and 1 and 3 month follow up
Secondary outcome [20] 334076 0
Use of services for a physical health condition questions (self developed)
Timepoint [20] 334076 0
Pre, post and 1 and 3 month follow up
Secondary outcome [21] 334077 0
Use of mental health services questions (self developed)
Timepoint [21] 334077 0
Pre, post and 1 and 3 month follow up
Secondary outcome [22] 334078 0
Quality of Life Rating question - 6 point scale (self developed)
Timepoint [22] 334078 0
Pre, post and 1 and 3 month follow up
Secondary outcome [23] 334079 0
Mental Health Rating question - 6 point scale (self developed)
Timepoint [23] 334079 0
Pre, post and 1 and 3 month follow up
Secondary outcome [24] 334080 0
Physical Health Rating question - 6 point scale (self developed)
Timepoint [24] 334080 0
Pre, post and 1 and 3 month follow up
Secondary outcome [25] 334081 0
Anxiety subtype questions (self developed)
Timepoint [25] 334081 0
Pre, post and 1 and 3 month follow up

Eligibility
Key inclusion criteria
Participants must be 18 years or older and concerned about their sleep.

iSleepWell has been written for people with insomnia symptoms and therefore recruitment will focus on people with insomnia. However, people who have very minimal symptoms are able to register if they wish too. The program is also preventative in nature and therefore people with occasional sleeping difficulties may also benefit from the program
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No internet access, does not create a My Digital Health account (requires the provision of a valid email address), does not provide consent to study conditions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be invited to register for the study on the iSleepWell child website (or via the parent website - My Digital Health) following My Digital Health account creation. Once an account is created, they will be required to provide their informed consent after reading through the iSleepWell Plain Language Information Statement. Following informed consent, participants will then be presented with the pre-intervention assessment questionnaires. Once completed, the participant is provided access to the iSleepWell program immediately.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Pre-, post- and follow-up variables will be subjected to mixed methods repeated measures to determine significant changes over time.

Previous research has reported medium to large effects can be expected for the primary measures of interest (ISI symptoms). Therefore, assuming a conservative medium effect (i.e. GPower f(v) test = 0.30), significance set at 5% (p = .05), power at 80%, a sample of 35 will be required to demonstrate statistical significance on the primary analysis. However, allowing for a 50% attrition rate, we will be required to recruit N = 70 participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 8800 0
New Zealand
State/province [1] 8800 0
Country [2] 8801 0
Canada
State/province [2] 8801 0
Country [3] 8802 0
United Kingdom
State/province [3] 8802 0
Country [4] 8803 0
United States of America
State/province [4] 8803 0

Funding & Sponsors
Funding source category [1] 295566 0
University
Name [1] 295566 0
Federation University
Address [1] 295566 0
University Drive, Mt Helen Campus, Victoria, 3350
Country [1] 295566 0
Australia
Primary sponsor type
University
Name
Federation University
Address
University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 294392 0
None
Name [1] 294392 0
Address [1] 294392 0
Country [1] 294392 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296885 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 296885 0
Federation University. Office 218, Building F, Mt Helen Campus. PO Box 663, Ballarat, 3353
Ethics committee country [1] 296885 0
Australia
Date submitted for ethics approval [1] 296885 0
27/06/2016
Approval date [1] 296885 0
27/07/2016
Ethics approval number [1] 296885 0
A16-198

Summary
Brief summary
A cognitive behavioural and biopsychosocially-based digital health program (called iSleepWell) for decreasing insomnia and stress symptoms will be evaluated.iSleepWell is one of the digital health programs offered through the My Digital Health platform. People visiting the iSleepWell site or the My Digital Health platform, in response to advertisements or through self interest, will be informed of the availability of the iSleepWell program and invited to participate in the study. Consenting participants will be provided with immediate access to the iSleepWell digital health program, following completion of the pre-intervention schedule.

iSleepWell is a self-help digital health program designed to provide people with information and strategies to address their insomnia and stress symptoms. iSleepWell contains five core modules, delivered over 7 weeks. Each module will take approximately 25 minutes to complete. In addition, in order to reinforce the module-based information, there are 30 minutes of offline activities per week. Participants will also receive automated emails (e.g., to remind them to log on, to complete their daily mood survey, when to complete post/follow-up questionnaires) and will be asked several questions at the beginning of each module to help evaluate the program modules.

Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 2, 4, 6) assessments, post-intervention assessment (Week 8) and a 1 and 3 month follow-up assessment (Week 12 & Week 20 respectively). Participants will also be asked questions relating to their program engagement levels at post assessment.

It is expected that people who undertake iSleepWell will show reductions in their insomnia symptoms at post-intervention and follow-up assessment time points, as well as decreases in stress, anxiety and or depressive symptoms.
Trial website
https://isleepwell2.mydigitalhealth.org.au (direct, child site)
https://www.mydigitalhealth.org.au (parent site)
Trial related presentations / publications
Public notes
iSleepWell is globally accessible via the web.

Contacts
Principal investigator
Name 72334 0
Prof Britt Klein
Address 72334 0
Federation University.
University Drive, Mt Helen Campus, Victoria, 3350
Country 72334 0
Australia
Phone 72334 0
+61 3 5327 6717
Fax 72334 0
Email 72334 0
b.klein@federation.edu.au
Contact person for public queries
Name 72335 0
Prof Britt Klein
Address 72335 0
Federation University.
University Drive, Mt Helen Campus, Victoria, 3350
Country 72335 0
Australia
Phone 72335 0
+61 3 5327 6717
Fax 72335 0
Email 72335 0
b.klein@federation.edu.au
Contact person for scientific queries
Name 72336 0
Prof Britt Klein
Address 72336 0
Federation University.
University Drive. Mt Helen Campus. Victoria, 3350
Country 72336 0
Australia
Phone 72336 0
+61 3 5327 6717
Fax 72336 0
Email 72336 0
b.klein@federation.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Relevant individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
No start or end date as yet determined.
Available to whom?
Case-by-case basis at the discretion of Principal Investigator.
Available for what types of analyses?
Case-by-case basis at the discretion of Principal Investigator.
How or where can data be obtained?
Access subject to approval by Principal Investigator, followed by submission to the Ethical Review Committee to access the de-identified data and approval granted.
What supporting documents are/will be available?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 1088 0
Informed consent form
Citation [1] 1088 0
Link [1] 1088 0
Email [1] 1088 0
Other [1] 1088 0
https://isleepwell2.mydigitalhealth.org.au/plain-language-information-statement/ (participant)
https://isleepwell2.mydigitalhealth.org.au/hcp_plis/ (healthcare practitioner version)
Attachment [1] 1088 0
Summary results
No Results