Clinical trial NCT04127032: Internet-Delivered Cognitive Behaviour Therapy for Public Safety Personnel
Official title: Internet-Delivered Cognitive Behaviour Therapy (ICBT) for Public Safety Personnel (PSP): Examination of Engagement, Outcomes, Strengths and Challenges
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression, Anxiety
Psychological Trauma
Keywords: Internet
Cognitive Behavioral Therapy
Telemedicine
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Government of Canada
First posted: 2019-10-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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, 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, and 26 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)? Please note: as of December 2024, we are exploring the impact of the PSP Wellbeing Course on symptom improvement and functioning at 8, and 26 weeks post-enrollment. The impact of this course at weeks 8, 26, and 52 was previously explored and has been published
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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in depression
timeFrame: 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).
measure: Change in anxiety
timeFrame: 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).
measure: Change in posttraumatic stress
timeFrame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
measure: Change in posttraumatic stress
timeFrame: 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15 and 16 weeks
Secondary outcomes:
measure: Change in panic symptoms
timeFrame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
measure: Change in social anxiety
timeFrame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
measure: Change in anger
timeFrame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
measure: Change in sleep problems
timeFrame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
measure: Other sleep problems
timeFrame: screening
measure: Alcohol use
timeFrame: screening
measure: Drug use
timeFrame: screening
measure: Change in functioning
timeFrame: screening and 4, 8, 12, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
measure: Change in resiliency
timeFrame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
measure: Change in use of health services
timeFrame: screening and 8, 26, and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
measure: Treatment satisfaction
timeFrame: week 8
measure: Working alliance
timeFrame: week 8
measure: Lifetime Traumatic Events History
timeFrame: screening and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
measure: Worst Traumatic Event
timeFrame: screening and 52 weeks (note: as of December 2024, we are no longer collecting data at 52 weeks).
measure: Engagement and Homework Compliance
timeFrame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 weeks
measure: Change in Moral Injury
timeFrame: screening, 8 and 26 weeks.
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Department of Psychology and Canadian Institute for Public Safety Research and Treatment
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Heather D Hadjistavropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hadjistavropoulos HD, McCall HC, Thiessen DL, Huang Z, Carleton RN, Dear BF, Titov N. Initial Outcomes of Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy Tailored to Public Safety Personnel: Longitudinal Observational Study. J Med Internet Res. 2021 May 5;23(5):e27610. doi: 10.2196/27610.