App-based treatment for chronic insomnia in adults
Randomized Controlled Trial to Evaluate Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia
This study is testing an app-based therapy for chronic insomnia to see if it helps adults sleep better and reduce their need for sleep medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 415 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IWK Health Centre Academic / other |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT04962087 on ClinicalTrials.gov |
What this trial studies
This project consists of two related randomized controlled trials aimed at improving insomnia treatment accessibility through a cognitive behavioral therapy program delivered via a web-browser or smartphone app. Trial 1 targets adults with insomnia symptoms who are not currently prescribed sleep medications, while Trial 2 focuses on those who are tapering off benzodiazepine medications under medical supervision. The effectiveness of the Health enSuite Insomnia app will be evaluated in terms of symptom improvement and medication reduction. This approach seeks to enhance the availability of effective insomnia treatments and facilitate safe medication de-prescribing.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older experiencing insomnia symptoms at least three times per week for the past three months.
Not a fit: Patients who are currently pregnant, trying to become pregnant, or have a device without internet access may not benefit from this study.
Why it matters
Potential benefit: If successful, this app-based treatment could significantly improve insomnia symptoms and reduce reliance on sleep medications for patients.
How similar studies have performed: Other studies have shown success with app-based cognitive behavioral therapy for insomnia, indicating a promising approach for this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Halifax, Nova Scotia
- Centre for Research in Family Health, IWK Health — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Principal investigator: Patrick McGrath — IWK Health Centre
- Study coordinator: Jaisheen Kour Reen
- Email: TeamHealthEnSuite@iwk.nshealth.ca
- Phone: 1-877-341-8309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.