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

550 Participants Needed

Trial Summary

What is the purpose of this trial?

This project consists of two independent but related randomized controlled trials. Trial 1 will focus on people who are not currently prescribed BZRA medications. Trial 2 will focus on people who have been taking BZRA medications and are initiating gradual tapering of these medications as recommended and supervised by their primary health care provider.

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 data supports the effectiveness of the Health enSuite Insomnia treatment 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 effectiveness. Cognitive Behavioral Therapy for Insomnia, which is often included in such apps, is recommended as a first-line treatment for chronic insomnia. ^{1 2 3 4 5}

Is the Health enSuite App for Insomnia safe for humans?

The research does not provide specific safety data for the Health enSuite App for Insomnia, but it mentions that behavioral treatments for insomnia, like cognitive behavioral therapy, are generally considered safe. ^{1 6 7 8 9}

How does the Health enSuite App for Insomnia treatment differ from other insomnia treatments?

The Health enSuite App for Insomnia is unique because it leverages a mobile health application to provide personalized advice on sleep hygiene, relaxation techniques, and stimulus control, potentially offering a more accessible and autonomous way to manage insomnia compared to traditional therapies. ^{1 8 10 11 12}

Research Team

Patrick McGrath

Principal Investigator

IWK Health Centre

Eligibility Criteria

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 am 18 years old or older.

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

I am not taking any medications for insomnia.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Health enSuite Insomnia - Deprescribing Experimental Treatment 1 Intervention

All participants in Trial 2 will be initiating a gradual medication tapering schedule recommended to them by their physician. The module physicians use to refer their patients to the study includes a section where they fill out a brief drug history for sleep medications. This information is then used to generate a tapering schedule that the health care provider will review with their patient. Health care providers are responsible for providing appropriate medication counselling and follow-up care to supervise deprescribing. This study does not place any restriction on the usual care participants will receive.

Group II: Health enSuite Insomnia Experimental Treatment 1 Intervention

Health enSuite: Insomnia has been designed based on established cognitive behavioural treatments for insomnia and adapted to fit an automated interactive platform available via an internet enabled device. The program is divided into a series of treatment modules or levels that will be delivered over the course of 6-8 weeks. The content of these 6 levels includes the following components, a sleep diary, sleep restriction clock, sleep hygiene, relaxation techniques, sleep related thoughts and beliefs, and involving a support person.

Group III: Psychoeducation Control Active Control 1 Intervention

Participants allocated to the Control group will receive a version of the Health enSuite Insomnia app that contains a static psychoeducation module. It will contain information related to insomnia and its treatment. Topics covered will include a brief description of cognitive behavioural therapy for insomnia.

Group IV: Psychoeducation Control - Deprescribing Active Control 1 Intervention

Participants allocated to the Control group will receive a version of the Health enSuite Insomnia app that contains a static psychoeducation module. It will contain information related to insomnia and its treatment. Topics covered will include a brief description of cognitive behavioural therapy for insomnia and information about the benefits of medication de-prescribing for those in Trial 2.

Who Is Running the Clinical Trial?

IWK Health Centre

Lead Sponsor

Trials

131

Recruited

112,000+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Help for insomnia from the app store? A standardized rating of mobile health applications claiming to target insomnia. [2023]

2. Switzerland 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Systematic Review of Clinical Practice Guidelines for Insomnia Disorder. [2023]

4. England pubmed.ncbi.nlm.nih.gov

European guideline for the diagnosis and treatment of insomnia. [2022]

5. England 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. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Comparative effectiveness and safety of pharmacological and non-pharmacological interventions for insomnia: an overview of reviews. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Smartphone apps for insomnia: examining existing apps' usability and adherence to evidence-based principles for insomnia management. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Oral nonprescription treatment for insomnia: an evaluation of products with limited evidence. [2008]

10. England 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. [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

Mobile Phone-Delivered Cognitive Behavioral Therapy for Insomnia: A Randomized Waitlist Controlled Trial. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Therapeutic options for sleep-maintenance and sleep-onset insomnia. [2013]