NCT07021183

Brief Summary

This study evaluates an internet-delivered cognitive behavioural therapy for insomnia (ICBTi) intervention, known as the Sleep Course, adapted for public safety personnel (PSP) experiencing sleep difficulties. The study seeks to replicate prior results from an Australian version of the Sleep Course assessing its effectiveness and acceptability when offered to PSP.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
23mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Mar 2025Mar 2028

Study Start

First participant enrolled

March 6, 2025

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

March 31, 2025

Last Update Submit

April 9, 2026

Conditions

Keywords

InternetInternet-Delivered CBTDigital Mental Health InterventionsInsomniaSleep DifficultiesDepressionAnxietyPublic Safety Personnel

Outcome Measures

Primary Outcomes (1)

  • Change in insomnia

    Insomnia Severity Index (ISI). Includes 7 items rated on a 0 to 5 scale. Higher total scores indicate greater severity of insomnia symptoms over the past two weeks. Scores range from 0 to 28.

    Screening, week 7 (post-treatment), and 3-month follow-up

Secondary Outcomes (12)

  • Change in Sleep Quality

    Screening, start of lesson 1 (day 0), start of lesson 2 (day 7), start of lesson 3 (day 21), start of lesson 4 (day 35), and week 7 (post-treatment), and 3-month follow-up

  • Change in Sleep-Related Impairment

    Screening, week 7 (post-treatment), and 3 month follow up

  • Change in attitudes and beliefs about sleep

    Screening, week 7 (post-treatment) and 3-month follow-up

  • Change in depression

    Screening, week 7 (post-treatment) and 3-month follow-up

  • Change in anxiety

    Screening, week 7 (post treatment) and 3-month follow-up

  • +7 more secondary outcomes

Study Arms (1)

ICBT for insomnia

EXPERIMENTAL

Therapist-guided, internet-delivered cognitive behavioral therapy for insomnia (ICBTi)

Behavioral: Sleep Course

Interventions

Sleep CourseBEHAVIORAL

The Sleep Course previously developed and evaluated in Australia has been tailored to PSP and will be delivered to clients meeting participation criteria. The Sleep Course has been slightly adapted for PSP by including relevant statistics and literature pertaining to sleep disturbance in PSP. The Sleep Course has four lessons and includes optional therapist support for up to 8 - 12 weeks. Clients who request support will be contacted by their therapist by secure emails on their designated check-in dates. The therapist also reviews client progress in the course and emails clients on a designated check in date. Sometimes the therapist will call the client. Phone calls are typically made if a client is not logging in or if the therapist feels that a phone call would be a helpful way to provide support.

ICBT for insomnia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Current or former paid or volunteer PSP
  • Living in a province in Canada where PSPNET offers the Sleep Couse for the treatment period
  • Willingness to learn information and skills to self-manage sleep difficulties
  • Have internet access
  • Consent to Sleep Course, online therapy as provided by PSPNET, and associated research

You may not qualify if:

  • Current severe medical or psychiatric disorder (e.g. current and recent mania or psychosis, recent hospitalization for mental health concerns, actively suicidal, medical condition client thinks will interfere with treatment, severe substance use)
  • Unable to read and understand English. (All content is provided in English and staff is English speaking; pending findings of the research PSPNET will explore translating the course into French)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

RECRUITING

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Heather D Hadjistavropoulos, PhD

    University of Regina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather D Hadjistavropoulos, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2025

First Posted

June 13, 2025

Study Start

March 6, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations