Clinical trial NCT04335487: 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
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress
Depression
Anxiety
Keywords: Internet
Cognitive Behavioral Therapy
Telemedicine
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Government of Canada
First posted: 2020-04-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Preference trial
Primary purpose: TREATMENT

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, and 26 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 unless the participant does not have a physician and the clinician assesses the need for an emergency contact as low during the telephone screening. 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)? Please note: Effective December 2024, we have discontinued data collection at the 52-week post-enrollment mark. This decision was made due to low response rates at this time point and limited resources available to enhance enrollment efforts.
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); (h) replacing the Panic Disorder Severity Scale-Self Report (PDSS-SR) with a 2-item version of the same measure; (i) replacing the Drug Use Disorders Identification Test (DUDIT) with the condensed version (DUDIT-C); (j) adding the abbreviated clinical version of the Moral Injury Outcome Scale (MIOS-AC); and (k) no longer administering measures at week 52."

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

Primary outcomes:
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).
Secondary 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 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: 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 use of health services
timeFrame: screening and 8, 26, and 52 weeks
measure: Treatment satisfaction
timeFrame: week 8
measure: Working alliance
timeFrame: week 8
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 Collaborative Centre for Justice and Safety
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Heather D Hadjistavropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
References: