NCT04127032

Brief Summary

This study evaluates a transdiagnostic Internet-delivered cognitive behavioural therapy (ICBT) recently tailored for Canadian public safety personnel (PSP) reporting symptoms of depression, anxiety, or posttraumatic stress. Outcomes of interest include engagement with the intervention, changes in symptoms and functioning, and strengths and limitations of implementing ICBT with Canadian PSP.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Dec 2019

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Dec 2019Mar 2028

First Submitted

Initial submission to the registry

October 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
8.3 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 4, 2025

Status Verified

March 1, 2025

Enrollment Period

8.3 years

First QC Date

October 11, 2019

Last Update Submit

March 31, 2025

Conditions

Depression, AnxietyPsychological Trauma

Keywords

InternetCognitive Behavioral TherapyTelemedicine

Outcome Measures

Primary Outcomes (4)

  • Change in depression

    Patient Health Questionnaire - 9 Item (PHQ-9). Higher total scores indicate greater severity of depression. Scores range from 0 to 27. Note: this measure is only administered at weeks 9 through 16 for clients who are still engaged in treatment at those timepoints.

    screening and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  • Change in anxiety

    Generalized Anxiety Disorder - 7 Item (GAD-7). Higher total scores indicate greater severity of anxiety. Scores range from 0 to 21. Note: this measure is only administered at weeks 9 through 16 for clients who are still engaged in treatment at those timepoints.

    screening and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12, 13, 14, 15, 16, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  • Change in posttraumatic stress

    PTSD Checklist for DSM-5 (PCL-5). Higher total scores indicate greater severity of posttraumatic stress. Scores range from 0 to 80.

    screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  • Change in posttraumatic stress

    Abbreviated PTSD Checklist - Civilian Version (PCL-C). Higher total scores indicate greater severity of posttraumatic stress. Scores range from 5 to 30. Note: this measure is only administered at weeks 9 through 16 for clients who are still engaged in treatment at those timepoints.

    1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15 and 16 weeks

Secondary Outcomes (16)

  • Change in panic symptoms

    screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  • Change in social anxiety

    screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  • Change in anger

    screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  • Change in sleep problems

    screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).

  • Other sleep problems

    screening

  • +11 more secondary outcomes

Study Arms (1)

Tailored ICBT for PSP

EXPERIMENTAL

Therapist-guided, Internet-delivered cognitive behavioral therapy tailored specifically for Canadian public safety personnel.

Behavioral: PSP Wellbeing Course

Interventions

PSP Wellbeing CourseBEHAVIORAL

A tailored ICBT intervention will be delivered to public safety personnel who report symptoms of depression, anxiety, or posttraumatic stress. Clients will choose whether they prefer weekly therapist support, twice-weekly support, or monitored optional support. The intervention is designed to be completed in 8 weeks, but clients will be able to extend their access to therapist support by an additional 8 weeks (i.e., up to 16 weeks in total).

Tailored ICBT for PSP

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • residing in a Canadian province or territory in which PSPNET is able to offer services
  • endorsing symptoms of anxiety, depression, or post-traumatic stress
  • able to access a computer and internet service
  • willing to provide a physician as emergency contact unless the participant does not have a physician and the clinician conducting the telephone screening assesses the need for an emergency contact to be low.

You may not qualify if:

  • high suicide risk
  • suicide attempt or hospitalization in the last year
  • primary problems with psychosis, alcohol or drug problems, mania
  • currently receiving regular psychological treatment for anxiety or depression
  • not present in Canada during treatment
  • concerns about ICBT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology and Canadian Institute for Public Safety Research and Treatment

Regina, Saskatchewan, S4S 0A2, Canada

RECRUITING

Related Publications (3)

  • Price JA, McCall HC, Demyen SA, Spencer SM, Katz BM, Clairmont AP, Hadjistavropoulos HD. Optimization of Internet-Delivered Cognitive Behavioral Therapy for Canadian Leaders Within Public Safety: Qualitative Study. J Med Internet Res. 2025 Apr 17;27:e72321. doi: 10.2196/72321.

    PMID: 40245389DERIVED

  • Price JA, Gregory J, McCall HC, Landry CA, Beahm JD, Hadjistavropoulos HD. Client Perspectives of Case Stories in Internet-Delivered Cognitive Behavioral Therapy for Public Safety Personnel: Mixed Methods Study. JMIR Form Res. 2024 Oct 25;8:e64454. doi: 10.2196/64454.

    PMID: 39453705DERIVED

  • Hadjistavropoulos HD, McCall HC, Thiessen DL, Huang Z, Carleton RN, Dear BF, Titov N. Initial Outcomes of Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy Tailored to Public Safety Personnel: Longitudinal Observational Study. J Med Internet Res. 2021 May 5;23(5):e27610. doi: 10.2196/27610.

    PMID: 33949959DERIVED

Related Links

MeSH Terms

Conditions

DepressionAnxiety DisordersPsychological Trauma

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Study Officials

  • Heather D Hadjistavropoulos, PhD

    University of Regina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather D Hadjistavropoulos, PhD

CONTACT

306-585-5133heather.hadjistavropoulos@uregina.ca

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

October 11, 2019

First Posted

October 15, 2019

Study Start

December 1, 2019

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

April 4, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)