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Internet-Delivered Cognitive Behaviour Therapy for PTSD Among Public Safety Personnel

Primary Purpose

Posttraumatic Stress, Depression, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PSP PTSD Course
PSP Wellbeing Course
Sponsored by
University of Regina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress focused on measuring Internet, Cognitive Behavioral Therapy, Telemedicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Psychology and Collaborative Centre for Justice and SafetyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ICBT for PTSD Tailored for PSP

Transdiagnostic ICBT Tailored for PSP

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 8,16, 26, and 52 weeks, but at 16 weeks, it is only administered to clients who are still engaged in treatment at that time. 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 15 post-enrollment if clients are still engaged in treatment at those timepoints.

Secondary Outcome Measures

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 9, 10, 11, 12, 13, 14, 15, and 16 weeks for clients who are still engaged in treatment at those timepoints.
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 9, 10, 11, 12, 13, 14, 15, and 16 weeks for clients who are still engaged in treatment at those timepoints.
Change in panic symptoms
Panic Disorder Severity Scale (PDSS). Higher total scores indicate greater severity of panic symptoms. Scores range from 0 to 28. Note: this measure is only administered at 16 weeks for clients who are still engaged in treatment at that time. Note: this measure was replaced with an abbreviated, two-item version (the PDSS-SR-2).
Change in social anxiety
Mini Social Phobia Inventory (Mini-SPIN). Higher total scores indicate greater severity of social anxiety. Scores range from 0 to 12. Note: this measure is only administered at 16 weeks for clients who are still engaged in treatment at that time.
Change in anger
Dimensions of Anger Reactions (DAR-5) scale. Higher total scores indicate greater severity of anger problems. Scores range from 0 to 20. Note: this measure is only administered at 16 weeks for clients who are still engaged in treatment at that time.
Alcohol use
Alcohol Use Disorders Identification Test (AUDIT). Higher scores indicate greater alcohol consumption and alcohol-related problems. Scores ranger from 0 to 40.
Drug use
Drug Use Disorders Identification Test (DUDIT). Higher scores indicate greater drug use and drug-related problems. Scores ranger from 0 to 44.
Change in disability status
Work and Social Adjustment Scale (WSAS). Higher total scores indicate a greater degree of impairment. Total scores range from 0 to 40.Of note, we had originally planned to use the Sheehan Disability Scale but ultimately administered the Work and Social Adjustment scale as were unable to secure permission for the Sheehan Disability Scale. Note: this measure is only administered at 16 weeks for clients who are still engaged in treatment at that time.
Change in use of health services
Canadian Adapted Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P). This questionnaire is adapted from the TiC-P to assess use of health services and productivity loss due to health problems. Each item contributes uniquely to an estimate of the costs associated with a psychiatric condition. Note: this measure is only administered at 16 weeks for clients who are still engaged in treatment at that time.
Treatment satisfaction
Treatment Satisfaction Questionnaire. A bespoke questionnaire consisting of 19 items with varying response formats measuring treatment satisfaction and perceived treatment credibility. Items are not designed to be combined into a unitary measure. An abbreviated (10-item) version of this questionnaire will be administered at 16 weeks. Note: this measure is only administered at 16 weeks for clients who are still engaged in treatment at that time.
Working alliance
Working Alliance Inventory - Short Revised (WAI-SR). Higher scores indicate greater working alliance. Scores in three distinct domains of working alliance each range from 4 to 20. Note: this measure is only administered at 16 weeks for clients who are still engaged in treatment at that time.
Engagement and homework compliance
Homework Reflection. A bespoke questionnaire consisting of 8 items with varying response formats, designed to measure engagement with treatment tasks and help alert therapists to any challenges clients face. Items are not designed to be combined into a unitary measure. Note: this measure is only administered at 9, 10, 11, 12, 13, 14, 15, and 16 weeks for clients who are still engaged in treatment at those timepoints.

Full Information

First Posted
March 31, 2020
Last Updated
July 28, 2023
Sponsor
University of Regina
Collaborators
Government of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT04335487
Brief Title
Internet-Delivered Cognitive Behaviour Therapy for PTSD Among Public Safety Personnel
Official Title
Internet-Delivered Cognitive Behaviour Therapy for PTSD Among Public Safety Personnel: Open Cohort Preference Trial for Transdiagnostic or Disorder-Specific Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Regina
Collaborators
Government of Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Background: Public Safety Personnel (PSP) is a term that broadly encompasses personnel who ensure the safety and security of Canadians across jurisdictions, including, but not necessarily limited to, border services personnel, correctional employees, firefighters (career and volunteer), operational and intelligence personnel, paramedics, police officers, public safety communications officials (e.g., call centre operators/dispatchers), and search and rescue personnel. As a function of their vocations, PSP are frequently exposed to potentially psychologically traumatic events (e.g., threatened or actual physical assaults, sexual violence, fires, and explosions) and are at risk of posttraumatic stress injuries. Results from a recent survey with a large Canadian PSP sample showed 44.5% screened positive for one or more mental health disorders, which is much higher than the 10.1% diagnostic rate among the Canadian general public. The study showed that 23.2% of Canadian PSP screened positive for PTSD, and 25.7% screened positive for two or more mental disorders. For many Canadian PSP, access to in-person evidence-based care is impeded for several logistical reasons, including distance from services, long waiting lists, difficulty navigating services, and the cost of treatment. PSP also face attitudinal barriers, including concerns about stigma, discomfort admitting to needing help, distrust of service providers, and lack of awareness of their need for help. Internet-delivered cognitive behaviour therapy (ICBT) represents a convenient method for PSP to access care for mental health concerns, such as posttraumatic stress. In ICBT, clients receive access to standardized lessons that provide the same information and skills as traditional face-to-face CBT. In addition to weekly lessons, clients are encouraged to complete homework assignments to facilitate learning. Research shows that ICBT is effective at reducing symptoms of posttraumatic stress, and there is also evidence that the findings of research trials translate into routine clinic settings. Research Purpose: The current research project is designed to compare preference for disorder-specific program for PTSD (PSP PTSD Course) versus a transdiagnostic program for depression, anxiety, and PTSD (PSP Wellbeing Course); both courses have been adapted to be specific to PSP (e.g., case examples are relevant to PSP). The study will also examine engagement and outcomes of the courses. The current study outcome variables will include: 1) usage of both courses among Canadian PSP who are informed about the courses (e.g., # enrolling, completion rates); 2) symptoms of depression, anxiety, and PTSD, as well as secondary outcome measures (e.g., treatment satisfaction, disability) from PSP participants measured at 8, 26, and 52 week follow-up; and 3) strengths and challenges of both courses when offered to PSP. In order to take part, PSP will first complete an online questionnaire and telephone screening to assess whether they meet the following inclusion criteria: 1) 18 years of age or older; 2) resident of the Canadian provinces of Saskatchewan, Quebec, Nova Scotia, New Brunswick, Prince Edward Island, or Ontario; 3) endorsing symptoms of posttraumatic stress, but not high suicide risk or recent suicide attempts in the past year; 4) able to access and comfortable using computers and the internet; 5) not seeking help primarily for alcohol and or drugs, bipolar disorder, or psychotic symptoms; and 6) willing to provide an emergency contact. Eligible participants will be invited to choose either of the two courses. Both courses will be delivered by trained providers with graduate training in psychology or social work or graduate students under supervision. The programs were first offered in Saskatchewan and later translated into French and offered to PSP in Quebec, Nova Scotia, New Brunswick, Prince Edward Island, and Ontario. The primary research questions to be answered include: ENGAGEMENT: How many PSP will enroll in and complete each course? Of note, we had initially planned to investigate how often PSP engage with therapists and how often PSP extend support beyond 8 weeks, but unforeseen system-related challenges rendered these research questions difficult to investigate in an unintrusive manner, so we have abandoned these research questions. OUTCOMES: What will be the impact of the each course on symptom improvement and functioning at 8, 26, and 52 weeks post-enrollment (and at 16 weeks for clients still engaged in treatment at that time)? What factors will predict outcomes (e.g., symptom severity, demographics, engagement)? IMPLEMENTATION: What are stakeholder experiences, positive and negative, with each course? What are the suggested improvements to ICBT to meet the needs of PSP? Significance: This project will provide information that will inform future use of ICBT to assist PSP with symptoms of depression, anxiety, and PTSD. Deviations from Original Trial Protocol: We have made several changes to our methods since releasing our original trial protocol: (a) expanding access to this study to PSP residing in the Canadian provinces of Saskatchewan, Quebec, Nova Scotia, New Brunswick, Prince Edward Island, and Ontario due to interest from these provinces; (b) replacing the Sheehan Disability Scale with the Work and Social Adjustment Scale because we were unable to obtain permission to use the former; (c) removing a clinical interview from our planned outcome measures (Section H of the Mini International Neuropsychiatric Interview) due to lack of resources; (d) removing two questionnaires assessing exposure to potentially psychologically traumatic events (the Life Events Checklist for DSM-5 and a bespoke questionnaire inquiring about the worst event ever experienced) to reduce the burden of questionnaires on clients; (e) limiting our administration of outcome measures between 9 and 16 weeks post-enrollment to clients who are still engaged in treatment at those timepoints (i.e., rather than to all clients at those timepoints) to reduce the burden of questionnaires on clients; and (f) extending the trial and increasing our estimated enrollment from 50 participants to 300 participants to better address our research objectives and because we have been able to expand recruitment efforts across several provinces.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress, Depression, Anxiety
Keywords
Internet, Cognitive Behavioral Therapy, Telemedicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Preference trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICBT for PTSD Tailored for PSP
Arm Type
Experimental
Arm Description
Therapist-guided, Internet-delivered cognitive behavioral therapy for PTSD tailored specifically for Canadian public safety personnel.
Arm Title
Transdiagnostic ICBT Tailored for PSP
Arm Type
Experimental
Arm Description
Therapist-guided, transdiagnostic Internet-delivered cognitive behavioral therapy tailored specifically for Canadian public safety personnel.
Intervention Type
Behavioral
Intervention Name(s)
PSP PTSD Course
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
PSP Wellbeing Course
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in posttraumatic stress
Description
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 8,16, 26, and 52 weeks, but at 16 weeks, it is only administered to clients who are still engaged in treatment at that time. 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 15 post-enrollment if clients are still engaged in treatment at those timepoints.
Time Frame
screening and 8,16, 26, and 52 weeks
Secondary Outcome Measure Information:
Title
Change in depression
Description
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 9, 10, 11, 12, 13, 14, 15, and 16 weeks for clients who are still engaged in treatment at those timepoints.
Time Frame
screening and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 26, and 52 weeks
Title
Change in anxiety
Description
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 9, 10, 11, 12, 13, 14, 15, and 16 weeks for clients who are still engaged in treatment at those timepoints.
Time Frame
screening and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 26, and 52 weeks
Title
Change in panic symptoms
Description
Panic Disorder Severity Scale (PDSS). Higher total scores indicate greater severity of panic symptoms. Scores range from 0 to 28. Note: this measure is only administered at 16 weeks for clients who are still engaged in treatment at that time. Note: this measure was replaced with an abbreviated, two-item version (the PDSS-SR-2).
Time Frame
screening and 8, 16, 26, and 52 weeks
Title
Change in social anxiety
Description
Mini Social Phobia Inventory (Mini-SPIN). Higher total scores indicate greater severity of social anxiety. Scores range from 0 to 12. Note: this measure is only administered at 16 weeks for clients who are still engaged in treatment at that time.
Time Frame
screening and 8, 16, 26, and 52 weeks
Title
Change in anger
Description
Dimensions of Anger Reactions (DAR-5) scale. Higher total scores indicate greater severity of anger problems. Scores range from 0 to 20. Note: this measure is only administered at 16 weeks for clients who are still engaged in treatment at that time.
Time Frame
screening and 8, 16, 26, and 52 weeks
Title
Alcohol use
Description
Alcohol Use Disorders Identification Test (AUDIT). Higher scores indicate greater alcohol consumption and alcohol-related problems. Scores ranger from 0 to 40.
Time Frame
screening
Title
Drug use
Description
Drug Use Disorders Identification Test (DUDIT). Higher scores indicate greater drug use and drug-related problems. Scores ranger from 0 to 44.
Time Frame
screening
Title
Change in disability status
Description
Work and Social Adjustment Scale (WSAS). Higher total scores indicate a greater degree of impairment. Total scores range from 0 to 40.Of note, we had originally planned to use the Sheehan Disability Scale but ultimately administered the Work and Social Adjustment scale as were unable to secure permission for the Sheehan Disability Scale. Note: this measure is only administered at 16 weeks for clients who are still engaged in treatment at that time.
Time Frame
screening and 8, 16, 26, and 52 weeks
Title
Change in use of health services
Description
Canadian Adapted Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P). This questionnaire is adapted from the TiC-P to assess use of health services and productivity loss due to health problems. Each item contributes uniquely to an estimate of the costs associated with a psychiatric condition. Note: this measure is only administered at 16 weeks for clients who are still engaged in treatment at that time.
Time Frame
screening and 8, 16, 26, and 52 weeks
Title
Treatment satisfaction
Description
Treatment Satisfaction Questionnaire. A bespoke questionnaire consisting of 19 items with varying response formats measuring treatment satisfaction and perceived treatment credibility. Items are not designed to be combined into a unitary measure. An abbreviated (10-item) version of this questionnaire will be administered at 16 weeks. Note: this measure is only administered at 16 weeks for clients who are still engaged in treatment at that time.
Time Frame
8 and 16 weeks
Title
Working alliance
Description
Working Alliance Inventory - Short Revised (WAI-SR). Higher scores indicate greater working alliance. Scores in three distinct domains of working alliance each range from 4 to 20. Note: this measure is only administered at 16 weeks for clients who are still engaged in treatment at that time.
Time Frame
8 and 16 weeks
Title
Engagement and homework compliance
Description
Homework Reflection. A bespoke questionnaire consisting of 8 items with varying response formats, designed to measure engagement with treatment tasks and help alert therapists to any challenges clients face. Items are not designed to be combined into a unitary measure. Note: this measure is only administered at 9, 10, 11, 12, 13, 14, 15, and 16 weeks for clients who are still engaged in treatment at those timepoints.
Time Frame
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather D Hadjistavropoulos, PhD
Phone
306-585-5133
Email
heather.hadjistavropoulos@uregina.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather D Hadjistavropoulos, PhD
Organizational Affiliation
University of Regina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology and Collaborative Centre for Justice and Safety
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S 0A2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather D Hadjistavropoulos, PhD
Phone
306-585-5133
Email
heather.hadjistavropoulos@uregina.ca
First Name & Middle Initial & Last Name & Degree
Heather D Hadjistavropoulos, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.pspnet.ca/
Description
Additional information about PSPNET.

Learn more about this trial

Internet-Delivered Cognitive Behaviour Therapy for PTSD Among Public Safety Personnel

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