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

Official title

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

Overview

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.

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.

Interventions

• 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 s

Primary outcome measures

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

Secondary outcome measures (5)

• Change in Depression, Anxiety, and Stress Scores (DASS-21) [Time frame: 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]
• Change in Total Sleep Time [Time frame: 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]
• Change in Wake After Sleep Onset (WASO) [Time frame: Baseline assessment, 2 months post-randomization, 5 months post-randomization]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Centre for Research in Family Health, IWK Health — Halifax

Publications

• Chaput JP, Yau J, Rao DP, Morin CM. Prevalence of insomnia for Canadians aged 6 to 79. Health Rep. 2018 Dec 19;29(12):16-20. PMID 30566205
• Morin CM, Benca R. Chronic insomnia. Lancet. 2012 Mar 24;379(9821):1129-41. doi: 10.1016/S0140-6736(11)60750-2. Epub 2012 Jan 20. PMID 22265700
• Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016 Jul 19;165(2). doi: 10.7326/P16-9016. Epub 2016 May 3. No abstract available. PMID 27135191
• Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008 Oct 15;4(5):487-504. PMID 18853708
• van Straten A, van der Zweerde T, Kleiboer A, Cuijpers P, Morin CM, Lancee J. Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis. Sleep Med Rev. 2018 Apr;38:3-16. doi: 10.1016/j.smrv.2017.02.001. Epub 2017 Feb 9. PMID 28392168
• Trauer JM, Qian MY, Doyle JS, Rajaratnam SM, Cunnington D. Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Ann Intern Med. 2015 Aug 4;163(3):191-204. doi: 10.7326/M14-2841. PMID 26054060
• Koffel E, Bramoweth AD, Ulmer CS. Increasing access to and utilization of cognitive behavioral therapy for insomnia (CBT-I): a narrative review. J Gen Intern Med. 2018 Jun;33(6):955-962. doi: 10.1007/s11606-018-4390-1. Epub 2018 Apr 4. PMID 29619651
• Holbrook AM, Crowther R, Lotter A, Cheng C, King D. Meta-analysis of benzodiazepine use in the treatment of insomnia. CMAJ. 2000 Jan 25;162(2):225-33. PMID 10674059

Identifiers

NCT: NCT04962087 · 1026706

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗