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An open evaluation trial of the iSleepWell digital health program for insomnia and stress-related symptoms.

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.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000575336
Enrollment
37
Registered
2017-04-24
Start date
2017-07-23
Completion date
2021-01-12
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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,

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.

Sponsors

Federation University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026