Health enSuite App for Insomnia

Overseen By Maryam Akbari

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: IWK Health Centre

Must be taking: BZRA, Benzodiazepines

Disqualifiers: No internet, Pregnant, Shift work, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6-8 weeks

415 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an app that uses cognitive behavioral therapy (CBT) to help people with insomnia sleep better. The app, called Health enSuite Insomnia, guides users through various sleep improvement techniques over eight weeks. It suits those who have experienced trouble sleeping—such as staying asleep or waking up too early—at least three times a week for the past three months and have access to a smartphone or computer. Participants should not work overnight shifts or be parents of infants under one year old, as these factors can affect sleep differently from insomnia.

As an unphased trial, this study explores innovative solutions for improving sleep quality.

Will I have to stop taking my current medications?

If you are in Trial 1, you should not be on any insomnia medications. If you are in Trial 2, you will need to gradually reduce your BZRA medications under your doctor's guidance.

What prior data suggests that this app-based cognitive behavioral program is safe for treating insomnia?

Research has shown that the Health enSuite Insomnia app is based on well-established cognitive behavioral treatments for insomnia, using proven methods to improve sleep. Specific safety information for this app is not available. The trial does not follow the usual clinical trial phases, suggesting the app is likely considered low-risk.

Similarly, the Health enSuite Insomnia - Deprescribing version lacks specific safety information. It offers a safe, remote method to help users gradually reduce sleep medications, with technology that monitors user-reported behaviors.

Both app versions are designed to be non-invasive and safe. No reports of harmful effects exist, but it's important to consider personal health needs and consult healthcare providers if necessary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Health enSuite Insomnia for treating insomnia because it leverages an automated, web-based platform to deliver cognitive behavioral therapy for insomnia (CBT-I). Unlike traditional face-to-face CBT-I or medication approaches, this app-based treatment offers a convenient and accessible solution that users can engage with at their own pace and in their own space. The program is structured into eight modules over eight weeks, incorporating a sleep diary, sleep hygiene techniques, and strategies to change negative thoughts related to sleep, making it a comprehensive self-help tool. By putting effective therapy into users' hands through their devices, Health enSuite Insomnia has the potential to broaden access to treatment and improve sleep outcomes for many.

What evidence suggests that the Health enSuite Insomnia app is effective for reducing insomnia symptoms?

Research shows that cognitive behavioral therapy for insomnia (CBT-I) can significantly alleviate sleep problems. Studies have found that CBT-I improves sleep quality, reduces daytime tiredness, and enhances physical well-being in individuals with long-term insomnia. In this trial, participants in the Health enSuite Insomnia arm will use the Health enSuite app, which digitizes this effective therapy for easy access on personal devices. Although specific data on Health enSuite is limited, other online CBT-I programs have successfully eased insomnia symptoms. Overall, evidence suggests that apps like Health enSuite can improve sleep by employing proven CBT-I methods. ^{2 3 6 7 8}

Who Is on the Research Team?

Patrick McGrath

Principal Investigator

IWK Health Centre

Are You a Good Fit for This Trial?

Adults over 18 with chronic insomnia, experiencing symptoms at least thrice a week for over three months. The trial has two parts: one for those not on insomnia meds and another for those prescribed up to two BZRA or benzodiazepine medications and are tapering off under doctor supervision.

Inclusion Criteria

I have had trouble sleeping at least 3 nights a week for the last 3 months.

I am not taking any medications for insomnia.

I am currently taking 1 or 2 medications for sleep problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Health enSuite Insomnia app treatment or psychoeducation control over 6-8 weeks

6-8 weeks

Weekly app-based modules

Follow-up

Participants are monitored for changes in insomnia severity and medication use

12 weeks

Assessments at 8 and 20 weeks post-randomization

Deprescribing

Participants in Trial 2 initiate a gradual medication tapering schedule

8-20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Health enSuite Insomnia
• Health enSuite Insomnia - Deprescribing

Trial Overview The study is testing an app-based treatment called Health enSuite Insomnia in two randomized controlled trials. One trial is for adults not taking BZRA meds, while the other involves participants who are gradually stopping their BZRA medication use.

How Is the Trial Designed?

Group I: Health enSuite Insomnia Experimental Treatment 1 Intervention

Health enSuite: Insomnia has been designed based on established cognitive behavioral treatments for insomnia (2,5,6) and adapted to fit an automated interactive platform available via an internet enabled device. Previous research has found that CBT for insomnia can be delivered via a web-based platform (15,16). The program is divided into a series of treatment modules or levels that will be delivered over the course of 8 weeks. The content of these 8 levels includes the following components, a sleep diary, Introduction to Health EnSuite Insomnia, Sleep restriction clock, Medications, Herbal Remedies \& Sleep, Chronobiology \& Sleep Timing, Sleep hygiene, Relaxation techniques, Changing Negative Thoughts Related to Sleep, Light and Sleep.

Group II: Waitlist Control Active Control 1 Intervention

Participants allocated to the control group will not have access to Health enSuite Insomnia CBT-I content until the end of the trial. During the trial, they will receive treatment as usual and will not be restricted from accessing other standard care services for insomnia treatment.

Who Is Running the Clinical Trial?

IWK Health Centre

Lead Sponsor

Trials

131

Recruited

112,000+

Published Research Related to This Trial

The KANOPEE_2 smartphone app effectively reduced insomnia symptoms in users, with significant improvements in the Insomnia Severity Index scores from an average of 13.58 to 11.30 after the intervention, indicating a positive impact on sleep quality.

The app also increased sleep efficiency from 76.46% to 80.17%, demonstrating its potential as a practical tool for managing insomnia, especially in the context of increased sleep disturbances due to the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based virtual agents and insomnia management: A proof-of-concept study for new methods of autonomous screening and management of insomnia symptoms in the general population. Dupuy, L., Morin, CM., de Sevin, E., et al.[2022]

A randomized controlled trial with 151 participants showed that a fully automated mobile app for cognitive behavioral therapy for insomnia (CBT-I) significantly reduced insomnia severity and improved sleep efficiency compared to a waitlist control group, with effects lasting for at least 3 months.

The study indicates that the Sleepcare app can effectively treat mild insomnia, suggesting that mobile technology can enhance access to mental health treatments, although further research is needed to assess its effectiveness across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Phone-Delivered Cognitive Behavioral Therapy for Insomnia: A Randomized Waitlist Controlled Trial. Horsch, CH., Lancee, J., Griffioen-Both, F., et al.[2018]

Most nonprescription therapies for insomnia, including popular herbal remedies like chamomile and St. John's wort, lack rigorous scientific evidence supporting their effectiveness, as found in a review of various studies.

Some treatments, such as Valerian officinalis and first-generation histamine-1-receptor antagonists, show preliminary evidence of mild effectiveness for short-term use, but there are significant safety concerns with others like Jamaican dogwood and kava kava.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral nonprescription treatment for insomnia: an evaluation of products with limited evidence. Meolie, AL., Rosen, C., Kristo, D., et al.[2008]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is strongly recommended as the first-line treatment for chronic insomnia in adults, supported by high-quality evidence from systematic reviews.

Pharmacological treatments, such as benzodiazepines and certain antidepressants, can be used for short-term relief of insomnia, but other options like antihistamines and complementary therapies are not recommended due to low-quality evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European guideline for the diagnosis and treatment of insomnia. Riemann, D., Baglioni, C., Bassetti, C., et al.[2022]

Cognitive Behavioral Therapy (CBT) is recommended as an effective first-line treatment for adults with insomnia, supported by consistent evidence from high-quality systematic reviews.

Pharmacological treatments like zolpidem, suvorexant, and doxepin show effectiveness but lack sufficient safety data, making it hard to assess their risk-benefit ratio; they should be considered as short-term supplements to CBT or behavioral therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness and safety of pharmacological and non-pharmacological interventions for insomnia: an overview of reviews. Rios, P., Cardoso, R., Morra, D., et al.[2023]

The study involves 160 participants diagnosed with insomnia and aims to evaluate the effectiveness of various treatments, including internet-supported cognitive behavioral therapy, bright light therapy, physical activity, and body warming, over four weeks.

It seeks to personalize insomnia treatment by examining how different subtypes of insomnia may respond to these interventions, potentially leading to more effective and tailored therapies for individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-supported cognitive behavioral and chronobiological interventions and effect moderation by insomnia subtype: study protocol of a randomized controlled trial. Dekker, K., Benjamins, JS., Van Straten, A., et al.[2018]

Insomnia is a widespread issue that can lead to serious health and economic problems, and there are various treatment options available, including both nonpharmacologic methods like cognitive behavioral therapy and pharmacologic treatments such as ramelteon, a melatonin receptor agonist.

When prescribing treatments for insomnia, clinicians should carefully consider individual patient factors, such as age and medical history, and use medications cautiously, at the lowest effective doses, and for the shortest necessary duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic options for sleep-maintenance and sleep-onset insomnia. Morin, AK., Jarvis, CI., Lynch, AM.[2013]

This clinical trial involves 625 adults with hypertension and insomnia, comparing the efficacy of two cognitive behavioral treatments for insomnia (BBTI and SHUTi) against enhanced usual care over a period of 12 months.

The study aims to assess not only sleep disturbances but also the impact of these treatments on comorbid conditions like blood pressure and quality of life, potentially influencing real-world treatment delivery for insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial. Levenson, JC., Rollman, BL., Ritterband, LM., et al.[2019]

Out of 2236 mobile health applications targeting insomnia, only 53 were evaluated, with most showing moderate quality; functionality was rated highest, indicating that while they may work well, their overall effectiveness varies significantly.

Only 19% of the apps had scientific evidence supporting their claims, highlighting a need for more rigorous studies and independent platforms to assess and inform users about the quality and content of these applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Help for insomnia from the app store? A standardized rating of mobile health applications claiming to target insomnia. Simon, L., Reimann, J., Steubl, LS., et al.[2023]

Out of 357 mobile health apps reviewed for insomnia, only 12 met the criteria for further evaluation, indicating a limited availability of evidence-based tools for managing insomnia.

The reviewed apps showed moderate adherence to cognitive behavioral therapy for insomnia (CBT-I) principles and usability, suggesting there is significant potential for improvement and development of more effective mHealth solutions for insomnia management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone apps for insomnia: examining existing apps' usability and adherence to evidence-based principles for insomnia management. Yu, JS., Kuhn, E., Miller, KE., et al.[2019]

The KANOPEE app significantly improved insomnia symptoms more than the My Sleep Diary app, with users reporting a greater reduction in Insomnia Severity Index scores after 17 days of use.

KANOPEE users also experienced a notable increase in total sleep time, gaining an average of 48 minutes of sleep compared to just 16 minutes for My Sleep Diary users, especially benefiting those with moderate to severe insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Smartphone-Based Virtual Companion to Treat Insomniac Complaints in the General Population: Sleep Diary Monitoring Versus an Internet Autonomous Intervention. Philip, P., Dupuy, L., Sagaspe, P., et al.[2023]

The systematic review evaluated 10 clinical practice guidelines (CPGs) for insomnia treatment, finding that while four were of high quality, most recommended medication only after nonpharmacological options like cognitive behavioral therapy were ineffective or declined by patients.

There was significant variability in the recommendations for specific medications, dosages, and treatment duration, indicating a lack of consensus on pharmacotherapy approaches for insomnia disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Clinical Practice Guidelines for Insomnia Disorder. Seow, SY., Kwok, KFV., Tay, KH., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04962087

an App-based Treatment for Adult Chronic Insomnia Reducing the severity of insomnia symptoms (primary outcome); Increasing sleep efficiency and total sleep time (secondary outcomes); Reducing sleep onset ...

2. withpower.com withpower.com/trial/phase-sleep-initiation-and-maintenance-disorders-7-2021-ca170

Health enSuite App for Insomnia The research suggests that mobile health applications, like Health enSuite Insomnia, may help improve insomnia care, but there is limited data on their ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8754495/

Cognitive behavioral therapy for insomnia has sustained ... CBT-I produced sustained improvements in insomnia, fatigue, daytime sleepiness, and objectively measured physical function among adults with chronic HF.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1087079224000546

Sleep interventions for adults admitted to psychiatric ... Results indicated that non-pharmacological interventions based on cognitive behaviour therapy for insomnia improve sleep and may improve mental and physical ...

5. emedicine.medscape.com emedicine.medscape.com/article/1187829-treatment

Insomnia Treatment & Management A study of 291 patients aged 60 years and older (mean age, 70 years; 58% women) with confirmed insomnia disorder and no major depression within ...

6. play.google.com play.google.com/store/apps/details?id=ca.healthensuite.insomnia&hl=en_US

Health enSuite - Apps on Google Play Safety starts with understanding how developers collect and share your data. Data privacy and security practices may vary based on your use, ...

7. app.trialscreen.org app.trialscreen.org/trials/insomnia-health-ensuite-app-based-treatment-adult-chronic-trial-nct04962087

an App-based Treatment for Adult Chronic Insomnia Research studies have participation criteria to protect participants' safety, ensure reliable results, and make sure the study is scientifically and ethically ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35624078/

Help for insomnia from the app store? A standardized ... The present study aimed to systematically search the European Google Play and Apple App Store for mobile health applications targeting insomnia.