Internet-Delivered Cognitive Behaviour Therapy for Public Safety Personnel

Depression, Anxiety Clinical Trial

Official title:

Internet-Delivered Cognitive Behaviour Therapy (ICBT) for Public Safety Personnel (PSP): Examination of Engagement, Outcomes, Strengths and Challenges

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04127032
• Other study ID #: 2019-157
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: March 31, 2025

Study information

• Verified date: December 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 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.

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, public safety communications officials (e.g., call centre operators/dispatchers), correctional employees, firefighters, paramedics, border services personnel, operational and intelligence personnel, search and rescue personnel, and police officers. As a function of their vocations, PSP are frequently exposed to traumatic events (e.g., threatened or actual physical assaults, sexual violence, fires, and explosions) and are at risk of post-traumatic 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. For many Canadian PSP access to in-person evidence-based care is impeded for several reasons, including preference to self-manage symptoms, geographic barriers (e.g., difficulty accessing care while deployed to remote locations), logistical barriers (e.g., shift work limits access to standard service hours), stigma (e.g., perceptions of being evaluated negatively for having mental health concerns), growing waiting-lists, and limited resources (e.g., insufficient access to mental health care coverage).

Transdiagnostic Internet-delivered cognitive behaviour therapy (ICBT) represents a convenient method for PSP to access care for mental health concerns, such as depression, anxiety, and post-traumatic stress. In transdiagnostic ICBT, clients receive access to standardized lessons that provide the same information and skills as traditional face-to-face CBT. Divergent mental health symptoms are targeted within transdiagnostic ICBT by educating clients in strategies that apply to multiple conditions (e.g., cognitive restructuring, graded exposure); this helps to ensure multiple concerns are addressed in an efficient manner. This is important given high rates of mental health comorbidity. In addition to weekly lessons, clients are encouraged to complete homework assignments to facilitate learning. Research shows that transdiagnostic ICBT is effective at reducing symptoms of anxiety, depression and trauma and there is also evidence that the findings of research trials translate into routine clinic settings. Most commonly, ICBT is delivered with brief once weekly e-therapist assistance (~20 minutes) via the telephone or secure email over ~8 weeks. There are also encouraging research results that clients can benefit with lower levels of support, such as when treatment is largely self-directed but with automated reminder emails, e-therapist monitoring and optional e-therapist support as needed by clients.

Research purpose:

The purpose of the current research project is to explore outcomes of a transdiagnostic ICBT course that is specifically tailored for PSP (e.g., case examples are relevant to PSP), referred to as the PSP Wellbeing Course. Of particular interest in this study are: 1) the usage of the PSP Wellbeing Course among PSP who are informed about the PSP Wellbeing Course (e.g., # enrolling, completion rates, use of e-therapist support); 2) outcomes of the PSP Wellbeing Course with respect to diverse outcome measures (e.g., depression, anxiety, trauma, functioning) measured at 8, 26, and 52 week follow-up; and 3) strengths and challenges of the PSP Wellbeing Course when offered to Canadian 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) not endorsing 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 unless the participant does not have a physician and the clinician assesses the need for an emergency contact as low during the telephone screening. The PSP Wellbeing Course will be delivered by trained providers with graduate training in psychology or social work or graduate students under supervision. Of note, the program was first offered in Saskatchewan and later translated to French and offered to PSP who reside in Quebec as well (update: recruitment in Quebec began on September 23, 2020). The program was also expanded to PSP in Nova Scotia, New Brunswick, and Prince Edward Island in February 2022, as well as to PSP in Ontario in March 2023. Of note, a purely self-guided version of the PSP Wellbeing Course (i.e., without therapist guidance) was made available to PSP anywhere in Canada in English on December 1st, 2021 and in French on November 19th, 2022. The primary research questions to be answered include:

1. ENGAGEMENT: How many PSP will enroll in and complete the PSP Wellbeing Course? What will be the uptake of optional e-therapist support, versus 1x week or 2x week e-therapist support? What will be the length of support selected (8 week-16 week)?

2. OUTCOMES: What will be the impact of the PSP Wellbeing 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 the PSP Wellbeing 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 common mental health concerns. Data will be extracted and analyzed on a quarterly basis in order to provide a preliminary evaluation of engagement, outcomes and implementation experiences and determine if adjustments to ICBT are required. Once adjustments are completed or deemed unnecessary, data will be extracted and analyzed biannually.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Depression, Anxiety
• Psychological Trauma

Intervention

Behavioral:
• PSP Wellbeing Course
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).

Locations

Country	Name	City	State
Canada	Department of Psychology and Canadian Institute for Public Safety Research and Treatment	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 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
Primary	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
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.	screening and 8, 26, and 52 weeks
Primary	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 12 and 16 weeks for clients who are still engaged in treatment at those timepoints.	1, 2, 3, 4, 5, 6, 7, 12, and 16 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 6, 2023.	screening and 8, 26, and 52 weeks
Secondary	Change in social anxiety (French)	Social Interaction Phobia Scale (SIPS). Higher total scores indicate greater severity of social anxiety. Scores range from 0 to 56. This measure is administered only to clients of the French version of the PSP Wellbeing Course. Note: this measure is only administered at 16 weeks for clients who are still engaged in treatment at that time. Note: this measure was added on September 23, 2020.	screening and 8, 16, 26, and 52 weeks
Secondary	Change in social anxiety (English)	Mini-Social Phobia Inventory (Mini-SPIN). Higher total scores indicate greater severity of social anxiety. Scores range from 0 to 12. This measure is administered only to clients of the English version of the PSP Wellbeing Course. Note: this measure replaced the 6-item version of the Social Interaction Anxiety Scale and the 6-item version of the Social Phobia Scale (SIAS-6/SPS-6) 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	Change in sleep problems	Insomnia Severity Index (ISI). Higher total scores indicate greater severity of sleep problems. Scores range from 0 to 28. Note: this measure was added on December 3, 2020.	screening and 8, 26, and 52 weeks
Secondary	Other sleep problems	SLEEP-50 Questionnaire. This questionnaire consists of 50 items spanning 9 subscales. However, instead of administering and scoring the entire questionnaire, we are administering only 21 items for descriptive purposes. Note: this measure was added on December 3, 2020.	screening
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 resiliency	Brief Resiliency Scale (BRS). Higher total scores indicate greater resiliency. Total scores represent mean scores across the six items of the scale and range from 0 to 5. Note: this measure was added on December 3, 2020.	screening and 8, 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	Lifetime Traumatic Events History	Life Events Checklist for DSM-5 (LEC-5). A checklist of common traumatic events used to establish the nature of the traumatic events a respondent has experienced. This questionnaire is not intended to be scored.	screening and 52 weeks
Secondary	Worst Traumatic Event	Worst Traumatic Event Questionnaire. A checklist of common traumatic events used to establish the nature of the single worst traumatic event a respondent has experienced. This questionnaire is not intended to be scored.	screening and 52 weeks
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 the PSP Wellbeing Course.