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

NCT04962087 | Recruiting

• 1 other identifier: 1026706
• Study Type: interventional
• Target: 415
• Locations: 1 country
• Sites: 1

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

Keywords

Insomnia; Deprescribing; Cognitive Behavioural Therapy

Outcome Measures

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.

  Baseline assessment, 2 months post-randomization, 5 months post-randomization

Secondary Outcomes (5)

• Change in Depression, Anxiety, and Stress Scores (DASS-21)

  Baseline assessment, 2 months post-randomization, 5 months post-randomization

• Change in Sleep Efficiency

  Baseline assessment, 2 months post-randomization, 5 months post-randomization

• Change in Total Sleep Time

  Baseline assessment, 2 months post-randomization, 5 months post-randomization

• Change in Sleep Onset Latency

  Baseline assessment, 2 months post-randomization, 5 months post-randomization

• Change in Wake After Sleep Onset (WASO)

  Baseline assessment, 2 months post-randomization, 5 months post-randomization

Study Arms (2)

Health enSuite Insomnia

EXPERIMENTAL

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.

Behavioral: Experimental: Health enSuite Insomnia

Waitlist Control

NO INTERVENTION

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 BEHAVIORAL

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.

Health enSuite Insomnia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

Centre for Research in Family Health, IWK Health

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Patrick McGrath

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaisheen Kour Reen

CONTACT

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

Maryam Akbari

CONTACT

TeamHealthEnSuite@iwk.nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This project consists of a pragmatic randomized controlled trial (RCT). The Consolidated Standards of Reporting Trials (CONSORT) recommendations (http://www.consort-statement.org/) will guide the methodology. Participants will be randomly allocated in a 1:1 ratio to either the intervention group or a waitlist control group. Participants in both groups will complete self-assessments including key outcome measures at baseline before starting the study, at two months post-randomization, and again at five months post-randomization. Participants in the intervention group will receive the full Health enSuite Insomnia program immediately after being randomized to this group. Participants in the waitlist control group will be waitlisted during the study. After their participation in the study has ended, participants in the waitlist control group will be given access to the full Health enSuite Insomnia program for two months.

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 14, 2021
• Study Start: August 29, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: From study closure to five years post publication.
• Access Criteria: During Consent, participants will be offered the option of allowing their de-identified study data to be re-used by other approved researchers under the conditions that the research projects are approved by an appropriate ethics board and the researchers sign an agreement ensuring confidentiality and restricting data use only to the approved study. A database will be created containing only the data for those participants who agree will be available to researchers who meet these criteria.

Locations

CA (1)