Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia

August 22, 2025 updated by: Patrick J. McGrath, IWK Health Centre

Randomized Controlled Trial to Evaluate Health enSuite Insomnia: an App-based Treatment for Adult 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Insomnia or insufficient sleep is one of the most prevalent public health issues. Nearly 1 in 4 Canadians over the age of 18 years report having difficulty falling asleep or maintaining sleep, the majority of whom have experienced these insomnia symptoms for more than a year. Chronic insomnia is characterized by one or more of the following symptoms occurring for at least three nights per week for at least 3 months: difficulty falling asleep, trouble maintaining sleep, difficulty in getting back to sleep, poor quality of sleep, and waking up too early the next morning. These symptoms persist despite adequate opportunity for sleep and are accompanied by significant impairments in daytime functioning.

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.

Study Type

Interventional

Enrollment (Estimated)

415

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • Recruiting
        • Centre for Research in Family Health, IWK Health
        • Contact:
          • Patrick McGrath, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

To be eligible for this study, participants must meet all of the following criteria:

  • Age 18 years or older Rationale: The intervention is designed for adults. Sleep patterns, treatment needs, and legal capacity for consent differ in children and adolescents, so participants must be legal adults to provide informed consent and to ensure relevance of the treatment content.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Insomnia Severity Index (ISI) Score
Time Frame: Baseline assessment, 2 months post-randomization, 5 months post-randomization
The ISI is a 7-item questionnaire measuring insomnia severity, dissatisfaction with sleep, interference with daily functioning, and daytime impairment. Scores range from 0-28, with higher scores indicating more severe insomnia.
Baseline assessment, 2 months post-randomization, 5 months post-randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression, Anxiety, and Stress Scores (DASS-21)
Time Frame: Baseline assessment, 2 months post-randomization, 5 months post-randomization
The DASS-21 is a 21-item questionnaire measuring psychological distress across three subscales: depression, anxiety, and stress. Each item is scored 0-3, and higher scores indicate greater distress.
Baseline assessment, 2 months post-randomization, 5 months post-randomization
Change in Sleep Efficiency
Time Frame: Baseline assessment, 2 months post-randomization, 5 months post-randomization
Sleep efficiency will be calculated from sleep diary data as the ratio of total sleep time to time in bed (percentage).
Baseline assessment, 2 months post-randomization, 5 months post-randomization
Change in Total Sleep Time
Time Frame: Baseline assessment, 2 months post-randomization, 5 months post-randomization
Total sleep time in hours will be calculated from daily sleep diaries. Unit of Measure: Hours of sleep (hours/night).
Baseline assessment, 2 months post-randomization, 5 months post-randomization
Change in Sleep Onset Latency
Time Frame: Baseline assessment, 2 months post-randomization, 5 months post-randomization

Sleep onset latency (minutes taken to fall asleep) will be measured via sleep diary.

Unit of Measure: Minutes.
Baseline assessment, 2 months post-randomization, 5 months post-randomization
Change in Wake After Sleep Onset (WASO)
Time Frame: Baseline assessment, 2 months post-randomization, 5 months post-randomization

WASO (total time awake after initially falling asleep) will be recorded via sleep diary.

Unit of Measure: Minutes.
Baseline assessment, 2 months post-randomization, 5 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IWK Health Centre

Investigators

  • Principal Investigator: Patrick McGrath, IWK Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

July 5, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1026706

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data sets may be retained and stored within the Centre for Research in Family Health as required for future research or program development, if merited. During Consent, participants will be offered the option of allowing their de-identified study data to be re-used by other approved researchers under the conditions that the research projects are approved by an appropriate ethics board and the researchers sign an agreement ensuring confidentiality and restricting data use only to the approved study. A database will be created containing only the data for those participants who agree will be available to researchers who meet these criteria.

IPD Sharing Time Frame

From study closure to five years post publication.

IPD Sharing Access Criteria

During Consent, participants will be offered the option of allowing their de-identified study data to be re-used by other approved researchers under the conditions that the research projects are approved by an appropriate ethics board and the researchers sign an agreement ensuring confidentiality and restricting data use only to the approved study. A database will be created containing only the data for those participants who agree will be available to researchers who meet these criteria.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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