Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia
ConditionInsomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIWK Health Centre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Experimental: Health enSuite Insomnia
BehavioralHealth 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.
Treatment groups
415 Participants
are divided into 2 treatment groupsGroup A: Health enSuite InsomniaExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Insomnia Severity Index (ISI) Score
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.
Time frame
Baseline assessment, 2 months post-randomization, 5 months post-randomizationSecondary outcomes
1
Change in Depression, Anxiety, and Stress Scores (DASS-21)
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.
Time frame
Baseline assessment, 2 months post-randomization, 5 months post-randomization2
Change in Sleep Efficiency
Sleep efficiency will be calculated from sleep diary data as the ratio of total sleep time to time in bed (percentage).
Time frame
Baseline assessment, 2 months post-randomization, 5 months post-randomization3
Change in Total Sleep Time
Total sleep time in hours will be calculated from daily sleep diaries. Unit of Measure: Hours of sleep (hours/night).
Time frame
Baseline assessment, 2 months post-randomization, 5 months post-randomization4
Change in Sleep Onset Latency
Sleep onset latency (minutes taken to fall asleep) will be measured via sleep diary. Unit of Measure: Minutes.
Time frame
Baseline assessment, 2 months post-randomization, 5 months post-randomizationSponsors and contacts
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Source ClinicalTrials.gov