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โ† Trials
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Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia

RecruitingNAAges 18 Years - anyAllIWK Health Centre
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Experimental: Health enSuite Insomnia
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Where

1 site
Centre for Research in Family Health, IWK Health
Halifax, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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