- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04335487
Internet-Delivered Cognitive Behaviour Therapy for PTSD Among Public Safety Personnel
Internet-Delivered Cognitive Behaviour Therapy for PTSD Among Public Safety Personnel: Open Cohort Preference Trial for Transdiagnostic or Disorder-Specific Therapy
Study Overview
Status
Conditions
Intervention / Treatment
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? 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; (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; (g) replacing the 6-item version of the Social Interaction Anxiety Scale and the 6-item version of the Social Phobia Scale (SIAS-6/SPS-6) with the Mini Social Phobia Inventory (Mini-SPIN); and (h) replacing the Panic Disorder Severity Scale-Self Report (PDSS-SR) with a 2-item version of the same measure.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Heather D Hadjistavropoulos, PhD
- Phone Number: 306-585-5133
- Email: heather.hadjistavropoulos@uregina.ca
Study Locations
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4S 0A2
- Recruiting
- Department of Psychology and Collaborative Centre for Justice and Safety
-
Contact:
- Heather D Hadjistavropoulos, PhD
- Phone Number: 306-585-5133
- Email: heather.hadjistavropoulos@uregina.ca
-
Principal Investigator:
- Heather D Hadjistavropoulos, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ICBT for PTSD Tailored for PSP
Therapist-guided, Internet-delivered cognitive behavioral therapy for PTSD tailored specifically for Canadian public safety personnel.
|
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).
|
Experimental: Transdiagnostic ICBT Tailored for PSP
Therapist-guided, transdiagnostic Internet-delivered cognitive behavioral therapy tailored specifically for Canadian public safety personnel.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in posttraumatic stress
Time Frame: screening and 8, 26, and 52 weeks
|
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 12 and 16 post-enrollment if clients are still engaged in treatment at those timepoints. |
screening and 8, 26, and 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol use
Time Frame: screening
|
Alcohol Use Disorders Identification Test (AUDIT).
Higher scores indicate greater alcohol consumption and alcohol-related problems.
Scores ranger from 0 to 40.
|
screening
|
Drug use
Time Frame: screening
|
Drug Use Disorders Identification Test (DUDIT).
Higher scores indicate greater drug use and drug-related problems.
Scores ranger from 0 to 44.
|
screening
|
Change in depression
Time Frame: screening and 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 26, and 52 weeks
|
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 12 and 16 weeks for clients who are still engaged in treatment at those timepoints.
|
screening and 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 26, and 52 weeks
|
Change in anxiety
Time Frame: screening and 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 26, and 52 weeks
|
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 12 and 16 weeks for clients who are still engaged in treatment at those timepoints.
|
screening and 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 26, and 52 weeks
|
Change in panic symptoms
Time Frame: screening and 8, 26, and 52 weeks
|
Panic Disorder Severity Scale-Self Report, (PDSS-SR), 2-item version.
Higher total scores indicate greater severity of panic symptoms.
Scores range from 0 to 8. Note: this measure replaced the full PDSS-SR on October 6th, 2023.
|
screening and 8, 26, and 52 weeks
|
Change in social anxiety
Time Frame: screening and 8, 26, and 52 weeks
|
Mini Social Phobia Inventory (Mini-SPIN).
Higher total scores indicate greater severity of social anxiety.
Scores range from 0 to 12. Note: this measure was added on October 6th, 2023.
|
screening and 8, 26, and 52 weeks
|
Change in anger
Time Frame: screening and 8, 26, and 52 weeks
|
Dimensions of Anger Reactions (DAR-5) scale.
Higher total scores indicate greater severity of anger problems.
Scores range from 0 to 20.
|
screening and 8, 26, and 52 weeks
|
Change in functioning
Time Frame: screening and 4, 8, 12, 26, and 52 weeks
|
Work and Social Adjustment Scale (WSAS).
Higher total scores indicate a greater degree of impairment.
Total scores range from 0 to 40.
Note: this measure is only administered at 12 weeks for clients who are still engaged in treatment at this timepoint.
Note: this measure replaced the Sheehan Disability Scale (SDS).
|
screening and 4, 8, 12, 26, and 52 weeks
|
Change in use of health services
Time Frame: screening and 8, 26, and 52 weeks
|
Health Service Use Questionnaire is a bespoke questionnaire that assesses the use of health services for mental health problems.
|
screening and 8, 26, and 52 weeks
|
Treatment satisfaction
Time Frame: week 8
|
Treatment Satisfaction Questionnaire.
A bespoke questionnaire consisting of 32 items with varying response formats measuring treatment satisfaction and perceived treatment credibility.
Items are not designed to be combined into a unitary measure.
|
week 8
|
Working alliance
Time Frame: week 8
|
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.
|
week 8
|
Engagement and homework compliance
Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 weeks.
|
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, and 12 weeks for clients who are still engaged in treatment at those timepoints.
|
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 weeks.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Heather D Hadjistavropoulos, PhD, University of Regina
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-157b
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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