Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia
NCT ID: NCT04962087
Last Updated: 2025-08-29
Study Results
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Basic Information
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RECRUITING
NA
415 participants
INTERVENTIONAL
2024-08-29
2026-07-01
Brief Summary
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Detailed Description
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Cognitive behavioral therapy for insomnia (CBT-I) is a multi-component intervention approach that is recommended as the first line of treatment for patients with persistent insomnia. It targets beliefs, thoughts, and expectations related to sleep as well as behavioral factors that result in sleep loss (sleep schedules, caffeine intake prior to bedtime, bright light in bedroom). These interventions have been found to improve the quality and the duration of sleep and improve daytime functioning. Despite the efficacy of CBT-I programs, they are not readily available to most patients. Therefore, our goal is to develop a CBT-I program that can be delivered through an internet connected phone, tablet, or computer and provide effective treatment to a wide range of people with chronic insomnia. Given that many individuals seek help for sleep problems online or face barriers accessing in-person care, internet-based CBT-I offers a scalable and accessible solution for those experiencing chronic insomnia.
Sleep medications are commonly used to manage insomnia symptoms. These include benzodiazepines such as temazepam and non-benzodiazepines like zopiclone, zolpidem, and zaleplon (often referred to as "Z drugs"). While these benzodiazepine receptor agonists (BZRAs) can be effective in the short term, long-term use is associated with diminishing benefits and potential risks, such as side effects, dependence, and-particularly in older adults-falls and cognitive impairment. Given these concerns, there is growing recognition of the importance of expanding access to non-pharmacological, evidence-based treatments for insomnia. Cognitive behavioral therapy for insomnia (CBT-I) is one such approach, but it remains underutilized due to limited availability. A widely accessible, app-based CBT-I program has the potential to fill this gap and offer a safer, long-term solution for individuals struggling with chronic insomnia.
This project consists of a randomized controlled trial. The objective of this trial is to test the effectiveness of an app-based cognitive behavioral program for insomnia (Health enSuite: Insomnia) in reducing insomnia symptoms.
The objectives will be to assess the effectiveness of CBT-I delivered through the Health enSuite app in:
* Reducing the severity of insomnia symptoms (primary outcome)
* Increasing sleep efficiency and total sleep time (secondary outcomes)
* Reducing sleep onset latency, time in bed, and the duration and frequency of awakenings at night (secondary outcomes)
* Reducing symptoms of psychological distress, anxiety, and depression (secondary outcomes) User engagement and satisfaction with Health enSuite: Insomnia will also be evaluated to inform subsequent efforts to make this program available on a larger scale.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Participants in both groups will complete self-assessments including key outcome measures at baseline before starting the study, at two months post-randomization, and again at five months post-randomization. Participants in the intervention group will receive the full Health enSuite Insomnia program immediately after being randomized to this group. Participants in the waitlist control group will be waitlisted during the study. After their participation in the study has ended, participants in the waitlist control group will be given access to the full Health enSuite Insomnia program for two months.
TREATMENT
NONE
Study Groups
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Health enSuite Insomnia
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.
Experimental: Health enSuite Insomnia
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.
Waitlist Control
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.
No interventions assigned to this group
Interventions
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Experimental: Health enSuite Insomnia
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.
Eligibility Criteria
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Inclusion Criteria
* Experience one or more insomnia symptoms (e.g., difficulty falling asleep, staying asleep, or waking too early) at least 3 times per week for at least 3 months Rationale: This criterion aligns with standard diagnostic criteria for chronic insomnia (e.g., DSM-5, ICSD-3 (9,10), ensuring that the intervention targets individuals with persistent and clinically meaningful symptoms.
* Have access to an internet-connected device (e.g., smartphone, tablet, or computer) Rationale: The CBT-I program is delivered entirely online via a mobile app or web platform. Participants must have reliable access to an internet-enabled device to complete program content, questionnaires, and sleep diaries.
* Not currently working regular overnight shifts (e.g., shifts starting between 10:00 PM and 12:00 AM and ending between 6:00 AM and 8:00 AM) Rationale: Night shift work disrupts circadian rhythms and sleep patterns in ways that are distinct from chronic insomnia. Individuals who work night shifts may not benefit from a standardized sleep schedule and could face difficulties adhering to the intervention.
* Not currently a parent of an infant under 1 year of age Rationale: Caring for an infant often involves frequent nighttime awakenings and irregular sleep patterns that are not necessarily reflective of insomnia. These participants may be unable to maintain a consistent sleep schedule as required by the intervention.
* Not currently pregnant or trying to become pregnant. Rationale: Sleep disturbances during pregnancy often result from physiological and hormonal changes, which differ from behavioral insomnia. The program has not been designed or tested for use during pregnancy, and eligibility will change if pregnancy occurs during the study.
* Have a total score greater than 7 on the Insomnia Severity Index (ISI) (11), indicating at least mild insomnia symptoms.
Rationale: The ISI is a validated tool used to assess the severity of insomnia symptoms. A score of 8 or more indicates at least mild insomnia, which supports the need for intervention. Excluding participants with minimal or no symptoms ensures that the program is delivered to those who stand to benefit and that changes in symptoms are measurable.
18 Years
ALL
No
Sponsors
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IWK Health Centre
OTHER
Responsible Party
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Patrick J. McGrath
Principal Investigator
Principal Investigators
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Patrick McGrath
Role: PRINCIPAL_INVESTIGATOR
IWK Health Centre
Locations
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Centre for Research in Family Health, IWK Health
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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Patrick McGrath, PhD
Role: primary
References
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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1026706
Identifier Type: -
Identifier Source: org_study_id
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