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

Depression Clinical Trial

Official title:

Internet-Delivered Cognitive Behaviour Therapy for PTSD Among Public Safety Personnel: Open Cohort Preference Trial for Transdiagnostic or Disorder-Specific Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04335487
• Other study ID #: 2019-157b
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: University of Regina
• Contact: Heather D Hadjistavropoulos, PhD
• Phone: 306-585-5133
• Email: heather.hadjistavropoulos[@]uregina.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. 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.

2. 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)?

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Posttraumatic Stress

Intervention

Behavioral:
• PSP PTSD Course
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).
• PSP Wellbeing Course
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).

Locations

Country	Name	City	State
Canada	Department of Psychology and Collaborative Centre for Justice and Safety	Regina	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Regina	Government of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 12 and 16 post-enrollment if clients are still engaged in treatment at those timepoints.	screening and 8, 26, and 52 weeks
Secondary	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 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
Secondary	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 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
Secondary	Change in panic symptoms	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
Secondary	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 was added on October 6th, 2023.	screening and 8, 26, and 52 weeks
Secondary	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.	screening and 8, 26, and 52 weeks
Secondary	Alcohol use	Alcohol Use Disorders Identification Test (AUDIT). Higher scores indicate greater alcohol consumption and alcohol-related problems. Scores ranger from 0 to 40.	screening
Secondary	Drug use	Drug Use Disorders Identification Test (DUDIT). Higher scores indicate greater drug use and drug-related problems. Scores ranger from 0 to 44.	screening
Secondary	Change in functioning	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
Secondary	Change in use of health services	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
Secondary	Treatment satisfaction	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
Secondary	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.	week 8
Secondary	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, 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.

External Links

•   Additional information about PSPNET.