NCT05816304

Brief Summary

The COVID-19 pandemic has resulted in increased workload and concerns about personal and family safety for frontline healthcare workers (HCWs), which can lead to decreased well-being and worsening mental health. Sleep disruption is particularly prevalent among HCWs providing frontline COVID-19 care. It can have direct consequences on their cognitive and emotional functioning, as well as on patient safety. Cognitive Behavioral Therapy for insomnia (CBTi) is a first-line treatment for insomnia. It has been shown to improve sleep health and wellbeing in the general population. However, there are significant barriers to delivering CBTi to frontline HCWs, including limited availability of trained sleep therapists and high costs. To address this, a Canada-wide randomized controlled trial is developed to determine the effectiveness of a digital CBTi program on the sleep health, mental health, wellness, and overall quality of life of frontline HCWs caring for COVID-19 patients. This study may provide an easily accessible and scalable sleep health intervention that can be included as part of a national and global response to the COVID-19 pandemic.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
366

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 16, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

December 11, 2024

Status Verified

August 1, 2024

Enrollment Period

1.5 years

First QC Date

March 30, 2023

Last Update Submit

December 5, 2024

Conditions

InsomniaPost Traumatic Stress DisorderAnxiety DisordersDepression

Keywords

Insomnia,sleep health,Cognitive Behavioral TherapyDigital Cognitive Behavioral TherapyHealth Care Workers

Outcome Measures

Primary Outcomes (1)

  • Assessing changes in the nature and severity of insomnia:

    Change in score on the Insomnia Severity Index (ISI ) from baseline to 12 weeks. ISI is a 7-item self-report questionnaire that assesses insomnia's nature, severity, and impact. Responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia. The score can be classified in the following way: the total score of 0-7 indicates "no clinically significant insomnia," 8-14 means "subthreshold insomnia," 15-21 is "clinical insomnia (moderate severity)," and 22-28 means "clinical insomnia (severe).

    12 weeks

Secondary Outcomes (13)

  • Sleep Condition Indicator

    12 weeks

  • Patient Reported Outcomes Measurement Information System(PROMIS ) Sleep Disturbance

    12 weeks

  • Patient Reported Outcomes Measurement Information System(PROMIS ) Sleep Related Impairment

    12 weeks

  • Generalized Anxiety Disorder (GAD) 7

    12 weeks

  • Warwick Edinburgh Mental Wellbeing Scale(WEMWBS )

    12 weeks

  • +8 more secondary outcomes

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

Digital CBTi will be offered using the SleepioTM website and supporting Sleepio™ app (Big Health Ltd., London, UK) via 6 sessions training program (spanning 6 to 12 weeks), lasting an average of 20 minutes each, unlocked weekly. The participant will receive the Sleepio intervention as soon as they become assigned.

Behavioral: Digital Cognitive Behavioral Therapy for Insomnia (dCBTi)

Attention Control arm

NO INTERVENTION

Participants in the control group will have access to online the sleep diary and sleep education material for 12 weeks, without the CBTi intervention by the Sleepio™ app (Big Health Ltd., London, UK). They will start the digital cognitive behavioral therapy for insomnia (dCBTi) intervention 12 weeks after the initial enrollment.

Interventions

Digital Cognitive Behavioral Therapy for Insomnia (dCBTi)BEHAVIORAL

Digital CBTi is a computer-based cognitive behavioral therapy that provides strategies to improve sleep and daytime function (concentration, productivity) and decreases symptoms of sleep-related attributions, night-time thought content in individuals with insomnia. It is easily accessible with any internet-connected device, eg, computer, tabs, and smartphones.

Also known as: Sleepio
Intervention arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Health care workers with probable insomnia disorder, as indicated by a score of 16 or lower on the Sleep Condition Indicator (SCI),
  • Self-identify as being involved in frontline management of patients;
  • Access to a mobile phone or a computer with Internet access.

You may not qualify if:

  • Participants requiring urgent CBT treatment as per their health care provider,
  • Participants received CBT in the past 3 months
  • Participants participating in other psychological treatments and/or drug trials during the study;
  • Self-reported additional sleep related disorders: sleep apnea or restless legs syndrome;
  • Significant other significant medical or psychiatric conditions e.g. life threatening (e.g. cancer), neurological conditions (e.g. epilepsy); severe depression , active suicide intent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Toronto Western Hospital - UHN

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Toronto Western Hospital

Toronto, Ontario, Canada

ENROLLING BY INVITATION

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersStress Disorders, Post-TraumaticAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersStress Disorders, TraumaticTrauma and Stressor Related DisordersBehavioral SymptomsBehavior

Study Officials

  • Mandeep Singh, MD, FRCPC

    Associate Professor, Department of Anesthesiology and Pain Medicine, Toronto Western Hospital, UHN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mandeep Singh, MBBS, FRCPC

CONTACT

416-603-5118mandeep.singh@uhn.ca

Abdel Basit Al Hawwari, MSN, RN

CONTACT

4166035800abdelbasit.alhawwari@uhn.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be randomized and allocated to either the intervention or attention control arm of the trial. Randomization will be centrally controlled, and allocation will be concealed using a secure, web-based randomization using the Research Electronic Data Capture (REDCap) platform.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm, pragmatic prospective, parallel, multi-center, randomized controlled trial (RCT)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 18, 2023

Study Start

June 16, 2023

Primary Completion

December 31, 2024

Study Completion

April 30, 2025

Last Updated

December 11, 2024

Record last verified: 2024-08

Locations

CA(2)