NCT04335487

Brief Summary

This study evaluates two Internet-delivered cognitive behavioural therapy (ICBT) interventions: one for symptoms of posttraumatic stress disorder (PTSD) and one for symptoms of anxiety, depression, and PTSD. Both interventions have been tailored for Canadian public safety personnel (PSP). Outcomes of interest include preference for disorder-specific or transdiagnostic care, engagement with the interventions, 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
300

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Jul 2020

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 Progress75%
Jul 2020Mar 2028

First Submitted

Initial submission to the registry

March 31, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 6, 2020

Completed
7.7 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 29, 2026

Status Verified

April 1, 2026

Enrollment Period

7.7 years

First QC Date

March 31, 2020

Last Update Submit

April 28, 2026

Conditions

Keywords

InternetCognitive Behavioral TherapyTelemedicine

Outcome Measures

Primary Outcomes (1)

  • 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. This measure is administered at screening and 8, 26, and 52 weeks. Abbreviated PTSD Checklist - Civilian Version (PCL-C). Six items. Higher total scores indicate greater severity of posttraumatic stress. Scores range from 5 to 30. This measure is administered to help clinicians track progress and is administered weekly at weeks 1 to 7 and 9 to 16 post-enrollment if clients are still engaged in treatment at those timepoints.

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

Secondary Outcomes (13)

  • Change in depression

    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

    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 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).

  • +8 more secondary outcomes

Study Arms (2)

ICBT for PTSD Tailored for PSP

EXPERIMENTAL

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

Behavioral: PSP PTSD Course

Transdiagnostic ICBT Tailored for PSP

EXPERIMENTAL

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

Behavioral: PSP Wellbeing Course

Interventions

PSP PTSD CourseBEHAVIORAL

A tailored ICBT intervention designed to treat symptoms of PTSD will be delivered to public safety personnel. Clients will be offered once a week support, but support can be increased to twice a week support if PSP request extra support. The intervention is designed to be completed in 8 weeks, but clients will be able to extend their treatment by an additional 8 weeks (i.e., up to 16 weeks in total).

ICBT for PTSD Tailored for PSP

A tailored ICBT intervention designed to treat symptoms of depression, anxiety, or PTSD will be delivered to public safety personnel. Clients will be offered once a week support, but support can be increased to twice a week support if PSP request extra support. The intervention is designed to be completed in 8 weeks, but clients will be able to extend their treatment by an additional 8 weeks (i.e., up to 16 weeks in total).

Transdiagnostic ICBT Tailored 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 Saskatchewan for the duration of the intervention
  • endorsing symptoms of post-traumatic stress
  • able to access a computer and internet service
  • willing to provide a physician as emergency contact

You may not qualify if:

  • high suicide risk
  • suicide attempt or hospitalization in the last year
  • primary problems with psychosis, alcohol or drug problems, or mania
  • currently receiving regular psychological treatment
  • concerns about ICBT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology and Collaborative Centre for Justice and Safety

Regina, Saskatchewan, S4S 0A2, Canada

RECRUITING

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Preference trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 6, 2020

Study Start

July 6, 2020

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations