Recruiting

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

Sponsor:

IWK Health Centre

Code:

NCT04962087

Conditions

Insomnia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Experimental: Health enSuite Insomnia

Study Details

Brief summary:

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.

Conditions

Insomnia

Study ID

NCT04962087

Start date

Aug 29, 2024

Status verified date

Aug, 2025

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

415 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Experimental: Health enSuite Insomnia

Primary outcome measure

Change in Insomnia Severity Index (ISI) Score [ Time Frame: Baseline assessment, 2 months post-randomization, 5 months post-randomization ]

Central Contacts and Locations

Central contacts

Jaisheen Kour Reen

1-877-341-8309 TeamHealthEnSuite@iwk.nshealth.ca

Maryam Akbari

TeamHealthEnSuite@iwk.nshealth.ca

Locations

Centre for Research in Family Health, IWK Health

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

More Information

Sponsor

IWK Health Centre

Last update posted

Aug 29, 2025

Last verified

Aug, 2025

Keywords

Insomnia
Deprescribing
Cognitive Behavioural Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by IWK Health Centre on 2025-08-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.