Posttraumatic Stress DisorderNCT05527509
Risk and Resiliency Factors in the RCMP: A Prospective Investigation
A study testing Emotional Resilience Skills Training (ERST) and Active Monitoring in people with Posttraumatic Stress Disorder and Major Depressive Disorder, run by University of Regina at 1 site in Canada.
Trial summary
The Royal Canadian Mounted Police (RCMP), like all public safety personnel (PSP), are frequently exposed to potentially psychologically traumatic events that contribute to posttraumatic stress injuries (PTSI). Addressing PTSI is impeded by the limited available research. Read more about this study
- Who is it for?
- Ages 19 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Major Depressive Disorder, Panic Disorder
- What is being tested?
- Emotional Resilience Skills Training (ERST) and Active Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 1 siteCanada
- Study dates
- 22 Apr 2019to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 57 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cadets starting the RCMP Cadet Training Program
Who cannot join
- Anyone other than cadets starting the RCMP Cadet Training Program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Regina
Regina, Saskatchewan, S4S0A2
R. Nicholas Carleton, PhD, 306-337-2387, nick.carleton@uregina.ca
Jonathan Burry, PM, 306-337-2667, Jonathan.Burry@uregina.ca
About this study
The Royal Canadian Mounted Police (RCMP), like all public safety personnel (PSP), are frequently exposed to potentially psychologically traumatic events that contribute to posttraumatic stress injuries (PTSI). Addressing PTSI is impeded by the limited available research. The RCMP are working to build evidence-based solutions to PTSI and other mental health challenges facing their members, which by extension will help all PSP, as part of the Canadian Government Federal Framework on Posttraumatic Stress Disorder. A key element is the "Longitudinal Study of Operational Stress Injuries / Étude longitudinale sur les traumatismes liés au stress opérationnel", a study which has been renamed "Risk and Resiliency Factors in the RCMP: A Prospective Investigation", and is referred to as the "RCMP Study" for short. The RCMP Study has been detailed online (www.rcmpstudy.ca) and in a recently published peer-reviewed protocol paper, "The Royal Canadian Mounted Police (RCMP) Study: protocol for a prospective investigation of mental health risk and resilience factors" (https://doi.org/10.24095/hpcdp.42.8.02). The RCMP Study, part of the concerted efforts by the RCMP to reduce PTSI by improving access to evidence-based assessments, treatments, and training as well as participant recruitment and RCMP Study developments to date. The RCMP Study has been designed to (1) develop, deploy and assess the impact of a system for ongoing annual, monthly and daily evidence-based assessments; (2) evaluate associations between demographic variables and PTSI; (3) longitudinally assess individual differences associated with PTSI; (4) augment the RCMP Cadet Training Program with skills to proactively mitigate PTSI; and (5) assess the impact of the augmented training condition (ATC) versus the standard training condition (STC). Participants in the STC (n = 480) and ATC (n = 480) are assessed before and after training and annually for 5 years on their deployment date; they also complete brief monthly and daily surveys. The RCMP Study results are expected to benefit the mental health of all participants, RCMP and PSP by reducing PTSI among all who serve.
Read the detailed description
Contemporary programs designed to support PSP mental health focus on increasing knowledge, reducing stigma and increasing help-seeking behaviours. Most studies of PTSI among PSP use cross-sectional data with short follow-up periods and assess very small subsets of variables posited as important. The limited research suggests the extant programs produce small, time-limited, highly variable benefits, likely due to low fidelity of delivery and limited specification of the mechanisms of action for mitigating PTSI. A particularly large, robustly designed trial with serving PSP compared psychoeducation to resilience training focussed on stress reduction and mindfulness, but found no statistically significant differences between the treatment groups. The researchers recommended future programs target specific modifiable individual differences. Individual differences that have been posited as resilience factors for psychopathology include some personality traits (i.e., extroversion, conscientiousness), hope, distress tolerance, optimism, interpersonal supports and positive life activities (e.g., exercise). Environmental factors, individual differences in psychological variables and individual differences in physiological variables have also been posited as risk factors for psychopathology. Environmental risk factors for psychopathology include PPTE and stressors (e.g., adverse childhood experiences, difficult socioeconomic status), family history of psychopathology, pre-existing psychopathology, and peritraumatic experiences. Individual psychological difference risk factors for psychopathology include some personality traits (e.g., neuroticism, world view), anxiety sensitivity, fear of negative evaluation, illness/injury sensitivity, pain-related anxiety/fear, intolerance of uncertainty, rumination, maladaptive self-appraisal, dissociation, and anger. Individual physiological difference risk factors for psychopathology include autonomic nervous system dysregulation. Aversive avoidant reactions to emotions are particularly critical risk factors for developing PTSI. Greater acceptance of emotions reduces reliance on avoidant coping strategies (e.g., alcohol use, avoiding reminders of the event) that exacerbate PTSI symptoms and, paradoxically, lead to more frequent negative emotions. The UP for the transdiagnostic treatment of emotional disorders (UP) is an evidence-based cognitive behaviour intervention designed to help individuals cultivate an approach-oriented stance towards emotions. The UP was designed to reduce symptoms of diverse anxiety- and mood-related disorders. The UP is supported by considerable evidence demonstrating transdiagnostic effectiveness across several delivery formats (e.g., individual, group, self). There is preliminary support for the UP as a proactive intervention to mitigate PTSI based on a randomized trial assessing participants with elevated nonclinical symptoms of depression and anxiety. Participants found the proactive Unified Protocol training to be highly acceptable and satisfying; at 1-month follow-up, they reported using the new skills "some" to "most" of the time, and statistically significant improvements were observed from baseline to 1-month follow-up. The UP appears to have potential as a proactive intervention that can be efficiently and effectively delivered to PSP to use to protect their mental health and enhance job satisfaction.
The RCMP Study necessarily uses a longitudinal prospective sequential experimental cohort design to create a clustered randomized trial that engages individual participants for 5.5 years. The structure of the Cadet Training Program does not allow for randomizing individual participants or individual groups of participants; nevertheless, meta-analytic evidence suggests that results from studies using this design and results from true randomized controlled trials do not typically differ meaningfully or statistically significantly, and both methods produce comparable groups at baseline. The RCMP Study hypotheses were pre-registered with aspredicted.org for the RCMP Study and associated hypotheses occurred on 7 November 2019 with the name, "Risk and resiliency factors in the RCMP: A prospective investigation" (#30654). Participants will be assessed for at least 66 months, via full assessments (i.e., self-report surveys, clinical interviews), monthly assessments (i.e., ~20 minute self-report surveys), daily assessments (i.e., ~1 minute self-report surveys), and biometric assessments, to allow for sufficient time to potentially develop PTSI symptoms after deployment. The data collection time-period uses seven broad milestones (see Table 1 for a summary and the supplemental tables at http://hdl.handle.net/10294/14680 for details): pre-training (T1); pre-deployment (T2; ~26 weeks after recruitment); and each of five deployment anniversaries starting about 12 months after deployment (T3 to T7). Each milestone involves a full assessment (FA1 to FA7). Recruitment will continue until 480 ATC participants have completed FA2. Unless extended by the RCMP, FA7 concludes data collection from each participant. Participants complete their first monthly assessment (i.e., MA1) about 4 weeks after completing FA1 and do not complete a monthly assessment concordant with completion of a full assessment (i.e., maximum number of monthly assessments per participant is 65). Participants can complete their first daily assessment (i.e., DA1) on the same day as FA1 (i.e., maximum number of daily assessments per participant ~2008). Cadets cannot be enrolled into the ATC until all STC participants have deployed, creating a necessarily 26-week gap that will be used to prepare to transition the Cadet Training Program to the ATC (see supplemental tables at http://hdl.handle.net/10294/14680).
- Mental health disorder prevalence rates at T1 for both groups, based on clinical interviews, or screening tools based on self-reported symptoms, will be comparable to the mental health disorder prevalence rates of the general population (i.e. 10.1%).
- At T1, both groups will report individual difference scores comparable to the general population.
- From T1 to T2, both groups will show reductions in variables associated with risk (e.g. anxiety sensitivity), increases in variables associated with resilience (e.g. distress tolerance), improvements in mental health (e.g. absolute, statistically significant or clinically significant reductions in self-reported symptoms of PTSI, reductions in proportions of participants meeting diagnostic criteria using either standardized cut-off scores, clinical interview results), as a function of the Cadet Training Program.
- The ATC group will, but the STC participants will not, show statistically significant changes associated with more than small effect sizes.
- Relative to the STC group, the ATC group at T2 will report statistically lower risk, greater resilience and better mental health.
- Both groups will show statistically significant predictive relationships between completing assessments, changes to individual differences over time (i.e. inversely with risk [e.g. anxiety sensitivity], positively with resilience [e.g. hope], inversely with mental health symptoms [e.g. symptoms of major depressive disorder]) and successful completion of the Cadet Training Program.
- Both groups will evidence statistically significant sequential predictive relationships for environmental factors or individual differences reported during the daily, monthly and full assessments.
- Both groups will show increases in risk, decreases in resilience and reductions in mental health at T3, T4, T5, T6, and T7, relative to T2; however, the ATC group will show slower increases in risk, slower decreases in resilience and slower reductions in mental health.
- Both groups will show a statistically significant relationship between changes in environmental factors or individual differences over time, frequency of exercise109 and other self-reported indicators of physical health.
- Relative to the STC group, the ATC group will report fewer symptoms of and instances of mental health disorders after T1.
- The ATC group will show a statistically significant relationship between changes in environmental factors or individual differences over time and engagement with ATC content.
- Relative to men, women will report more difficulties with mental disorder symptoms and occupational stressors.
- Changes in biological variables (i.e. autonomic nervous system reactivity, heart rate variability, cardiac mechanical changes) will be associated with environmental factors or individual differences.
The RCMP Study has been designed as an applied longitudinal prospective sequential experimental cohort research project. Participants, the RCMP as an organization, past, present and future RCMP and all PSP should benefit directly and indirectly from the RCMP Study. The benefits should occur irrespective of any specific RCMP Study component (i.e. risk variables, resilience variables, biological variables, the relative impact of the ATC). Through the RCMP Study, the RCMP have become global leaders in the international efforts to better support the mental health of all PSP. The current protocol paper provides details to inform and support similar efforts by other researchers.
- Conditions
- Posttraumatic Stress Disorder, Major Depressive Disorder, Panic Disorder, Generalized Anxiety Disorder, Trauma, Traumatic Stress Disorder
- Being tested
- Emotional Resilience Skills Training (ERST), Active Monitoring
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depressive Disorder, Major, Panic Disorder, Generalized Anxiety Disorder, Wounds and Injuries, Stress Disorders, Traumatic, Trauma and Stressor Related Disorders, Compassion Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Resilience Skills Training (ERST)Behavioural
Also called Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP)
The ERST training is designed as a "train the trainer" model. Sauer-Zavala, a co-developer of the UP, personally trained a group of RCMP trainers during a week-long interactive workshop. The trainers continue to have access to Sauer-Zavala for optional follow-up consultation and support related to delivery of the ERST training for questions or to address any issues that arise during training. Having consultation and support available for the trainers should help to offset concerns raised about ensuring training fidelity subsequent to other mental health programs. Participants have ongoing access to ERST to support skill retention after training is completed, which should help to offset previous indications of problems with skill development for mental health programs.
Active MonitoringBehavioural
Participants in the STC will be assessed for at least 66 months, via full assessments (i.e., self-report surveys, clinical interviews), monthly assessments (i.e., ~20 minute self-report surveys), daily assessments (i.e., ~1 minute self-report surveys), and biometric assessments. The self-monitoring and feedback should be inherently beneficial and should facilitate earlier access to evidence-based care, which is why the STC is considered an active comparator.
| Study group | Role | What they receive |
|---|---|---|
| Standard Training Condition (STC) | Active comparator | The STC has received the "standard" RCMP Depot Division ("Depot") Cadet Training Program as has been provided to cadets prior to June 2022. The STC and the ATC will complete the same standardized self-report assessments, clinical interview assessments, and biometric assessments, and receive the same feedback and reporting based on those assessments. Receives: Behavioral: Active Monitoring |
| Augmented Training Condition (ATC) | Experimental | The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) is an evidence-based cognitive-behavioral intervention designed to cultivate constructive approach-oriented emotional engagement. The 13-week Emotional Resilience Training (ERST) is an adaptation of the UP designed for use as a proactive training course. The ERST frames emotional experiences as natural responses to threat, rather than pathological occurrences to avoid; as such, the ERST is well-suited for mitigating health challenges and the skills may also help PSP to support persons in distress, including other PSP and the community members they all serve. The ERST training materials include an instructor guide, didactic PowerPoints, and a trainee workbook. The ERST was designed for seamless integration with the Cadet Training Program, effective June 2022, which is what creates the augmented training arm (i.e., the ATC). Receives: Behavioral: Emotional Resilience Skills Training (ERST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Posttraumatic Stress Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 26)
Posttraumatic Stress Disorder Checklist Version 5; Total scores range from 0 to 80; Higher scores indicate more severe symptoms.
Measured: Time 1 (pre-training; week 1), Time 2 (post-training; week 26)
Sustained Posttraumatic Stress Disorder Symptoms from Time 2 (post-training; week 26) to Time 7 (5-year follow-up)
Posttraumatic Stress Disorder Checklist Version 5; Total scores range from 0 to 80; Higher scores indicate more severe symptoms.
Measured: Time 2 (post-training; week 26), Time 3 (1-year follow-up), Time 4 (2-year follow-up), Time 5 (3-year follow-up), Time 6 (4-year follow-up), Time 7 (5-year follow-up)
Change in Major Depressive Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 26)
Patient Health Questionnaire - 9 (PHQ-9); Total scores range from 0 to 36; Higher scores indicate more severe symptoms.
Measured: Time 1 (pre-training; week 1), Time 2 (post-training; week 26)
Sustained Major Depressive Disorder Symptoms from Time 2 (post-training; week 26) to Time 7 (5-year follow-up)
Patient Health Questionnaire - 9 (PHQ-9); Total scores range from 0 to 36; Higher scores indicate more severe symptoms.
Measured: Time 2 (post-training; week 26), Time 3 (1-year follow-up), Time 4 (2-year follow-up), Time 5 (3-year follow-up), Time 6 (4-year follow-up), Time 7 (5-year follow-up)
Change in Generalized Anxiety Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 26)
Generalized Anxiety Disorder Scale - 7 (GAD-7); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
Measured: Time 1 (pre-training; week 1), Time 2 (post-training; week 26)
Sustained Generalized Anxiety Disorder Symptoms from Time 2 (post-training; week 26) to Time 7 (5-year follow-up)
Generalized Anxiety Disorder Scale - 7 (GAD-7); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
Measured: Time 2 (post-training; week 26), Time 3 (1-year follow-up), Time 4 (2-year follow-up), Time 5 (3-year follow-up), Time 6 (4-year follow-up), Time 7 (5-year follow-up)
Change in Panic Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 26)
Panic Disorder Severity Scale (PDSS); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
Measured: Time 1 (pre-training; week 1), Time 2 (post-training; week 26)
Sustained Panic Disorder Symptoms from Time 2 (post-training; week 26) to Time 7 (5-year follow-up)
Panic Disorder Severity Scale (PDSS); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
Measured: Time 2 (post-training; week 26), Time 3 (1-year follow-up), Time 4 (2-year follow-up), Time 5 (3-year follow-up), Time 6 (4-year follow-up), Time 7 (5-year follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start22 Apr 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The RCMP Study necessarily uses a longitudinal prospective sequential experimental cohort design to create a clustered randomized trial that engages individual participants for 5.5 years. The structure of the Cadet Training Program does not allow for randomizing individual participants or individual groups of participants; nevertheless, meta-analytic evidence suggests that results from studies using this design and results from true randomized controlled trials do not typically differ meaningfully or statistically significantly, and both methods produce comparable groups at baseline.
- Masking
- None (open label)
- Enrolment
- 960 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Canadian Mounted Police, Government of Canada, Ministry of Public Safety and Emergency Preparedness, Canadian Institute for Public Safety Research and Treatment
- Responsible party
- Sponsor
- Investigators
- R. Nicholas Carleton, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527509
- Sponsor's protocol ID
- 2019-055
- Status last verified
- Nov 2023
- First submitted
- 29 Aug 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are ethical and privacy concerns with respect to sharing the participant data, even after anonymization; as such, requests to access the datasets should be directed to the primary investigator and will be addressed on a case-by-case basis in connection with the University of Regina Research Ethics Board.
Publications
Carleton RN, Kratzig GP, Sauer-Zavala S, Neary JP, Lix LM, Fletcher AJ, Afifi TO, Brunet A, Martin R, Hamelin KS, Teckchandani TA, Jamshidi L, Maguire KQ, Gerhard D, McCarron M, Hoeber O, Jones NA, Stewart SH, Keane TM, Sareen J, Dobson K, Asmundson GJG. The Royal Canadian Mounted Police (RCMP) Study: protocol for a prospective investigation of mental health risk and resilience factors. Health Promot Chronic Dis Prev Can. 2022 Aug;42(8):319-333. doi: 10.24095/hpcdp.42.8.02.
PubMed 35993603Khoury JMB, Jamshidi L, Shields RE, Nisbet J, Afifi TO, Fletcher AJ, Stewart SH, Asmundson GJG, Sauer-Zavala S, Kratzig GP, Carleton RN. Putative risk and resiliency factors among Royal Canadian Mounted Police cadets. Front Psychol. 2023 Mar 15;14:1048573. doi: 10.3389/fpsyg.2023.1048573. eCollection 2023.
PubMed 37008880
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk and Resiliency Factors in the RCMP: A Prospective Investigation
- ClinicalTrials.gov ID
- NCT05527509
- Acronym / sponsor ID
- 2019-055
- Conditions
- Posttraumatic Stress Disorder, Major Depressive Disorder, Panic Disorder, Generalized Anxiety Disorder, Trauma, Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 960 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Royal Canadian Mounted Police, Government of Canada, Ministry of Public Safety and Emergency Preparedness, Canadian Institute for Public Safety Research and Treatment
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Royal Canadian Mounted Police (RCMP), like all public safety personnel (PSP), are frequently exposed to potentially psychologically traumatic events that contribute to posttraumatic stress injuries (PTSI). Addressing PTSI is impeded by the limited available research. The RCMP are working to build evidence-based solutions to PTSI and other mental health challenges facing their members, which by extension will help all PSP, as part of the Canadian Government Federal Framework on Posttraumatic Stress Disorder. A key element is the "Longitudinal Study of Operational Stress Injuries / Étude longitudinale sur les traumatismes liés au stress opérationnel", a study which has been renamed "Risk and Resiliency Factors in the RCMP: A Prospective Investigation", and is referred to as the "RCMP Study" for short. The RCMP Study has been detailed online (www.rcmpstudy.ca) and in a recently published peer-reviewed protocol paper, "The Royal Canadian Mounted Police (RCMP) Study: protocol for a prospective investigation of mental health risk and resilience factors" (https://doi.org/10.24095/hpcdp.42.8.02). The RCMP Study, part of the concerted efforts by the RCMP to reduce PTSI by improving access to evidence-based assessments, treatments, and training as well as participant recruitment and RCMP Study developments to date. The RCMP Study has been designed to (1) develop, deploy and assess the impact of a system for ongoing annual, monthly and daily evidence-based assessments; (2) evaluate associations between demographic variables and PTSI; (3) longitudinally assess individual differences associated with PTSI; (4) augment the RCMP Cadet Training Program with skills to proactively mitigate PTSI; and (5) assess the impact of the augmented training condition (ATC) versus the standard training condition (STC). Participants in the STC (n = 480) and ATC (n = 480) are assessed before and after training and annually for 5 years on their deployment date; they also complete brief monthly and daily surveys. The RCMP Study results are expected to benefit the mental health of all participants, RCMP and PSP by reducing PTSI among all who serve.
Detailed description
Contemporary programs designed to support PSP mental health focus on increasing knowledge, reducing stigma and increasing help-seeking behaviours. Most studies of PTSI among PSP use cross-sectional data with short follow-up periods and assess very small subsets of variables posited as important. The limited research suggests the extant programs produce small, time-limited, highly variable benefits, likely due to low fidelity of delivery and limited specification of the mechanisms of action for mitigating PTSI. A particularly large, robustly designed trial with serving PSP compared psychoeducation to resilience training focussed on stress reduction and mindfulness, but found no statistically significant differences between the treatment groups. The researchers recommended future programs target specific modifiable individual differences. Individual differences that have been posited as resilience factors for psychopathology include some personality traits (i.e., extroversion, conscientiousness), hope, distress tolerance, optimism, interpersonal supports and positive life activities (e.g., exercise). Environmental factors, individual differences in psychological variables and individual differences in physiological variables have also been posited as risk factors for psychopathology. Environmental risk factors for psychopathology include PPTE and stressors (e.g., adverse childhood experiences, difficult socioeconomic status), family history of psychopathology, pre-existing psychopathology, and peritraumatic experiences. Individual psychological difference risk factors for psychopathology include some personality traits (e.g., neuroticism, world view), anxiety sensitivity, fear of negative evaluation, illness/injury sensitivity, pain-related anxiety/fear, intolerance of uncertainty, rumination, maladaptive self-appraisal, dissociation, and anger. Individual physiological difference risk factors for psychopathology include autonomic nervous system dysregulation. Aversive avoidant reactions to emotions are particularly critical risk factors for developing PTSI. Greater acceptance of emotions reduces reliance on avoidant coping strategies (e.g., alcohol use, avoiding reminders of the event) that exacerbate PTSI symptoms and, paradoxically, lead to more frequent negative emotions. The UP for the transdiagnostic treatment of emotional disorders (UP) is an evidence-based cognitive behaviour intervention designed to help individuals cultivate an approach-oriented stance towards emotions. The UP was designed to reduce symptoms of diverse anxiety- and mood-related disorders. The UP is supported by considerable evidence demonstrating transdiagnostic effectiveness across several delivery formats (e.g., individual, group, self). There is preliminary support for the UP as a proactive intervention to mitigate PTSI based on a randomized trial assessing participants with elevated nonclinical symptoms of depression and anxiety. Participants found the proactive Unified Protocol training to be highly acceptable and satisfying; at 1-month follow-up, they reported using the new skills "some" to "most" of the time, and statistically significant improvements were observed from baseline to 1-month follow-up. The UP appears to have potential as a proactive intervention that can be efficiently and effectively delivered to PSP to use to protect their mental health and enhance job satisfaction.
The RCMP Study necessarily uses a longitudinal prospective sequential experimental cohort design to create a clustered randomized trial that engages individual participants for 5.5 years. The structure of the Cadet Training Program does not allow for randomizing individual participants or individual groups of participants; nevertheless, meta-analytic evidence suggests that results from studies using this design and results from true randomized controlled trials do not typically differ meaningfully or statistically significantly, and both methods produce comparable groups at baseline. The RCMP Study hypotheses were pre-registered with aspredicted.org for the RCMP Study and associated hypotheses occurred on 7 November 2019 with the name, "Risk and resiliency factors in the RCMP: A prospective investigation" (#30654). Participants will be assessed for at least 66 months, via full assessments (i.e., self-report surveys, clinical interviews), monthly assessments (i.e., ~20 minute self-report surveys), daily assessments (i.e., ~1 minute self-report surveys), and biometric assessments, to allow for sufficient time to potentially develop PTSI symptoms after deployment. The data collection time-period uses seven broad milestones (see Table 1 for a summary and the supplemental tables at http://hdl.handle.net/10294/14680 for details): pre-training (T1); pre-deployment (T2; ~26 weeks after recruitment); and each of five deployment anniversaries starting about 12 months after deployment (T3 to T7). Each milestone involves a full assessment (FA1 to FA7). Recruitment will continue until 480 ATC participants have completed FA2. Unless extended by the RCMP, FA7 concludes data collection from each participant. Participants complete their first monthly assessment (i.e., MA1) about 4 weeks after completing FA1 and do not complete a monthly assessment concordant with completion of a full assessment (i.e., maximum number of monthly assessments per participant is 65). Participants can complete their first daily assessment (i.e., DA1) on the same day as FA1 (i.e., maximum number of daily assessments per participant ~2008). Cadets cannot be enrolled into the ATC until all STC participants have deployed, creating a necessarily 26-week gap that will be used to prepare to transition the Cadet Training Program to the ATC (see supplemental tables at http://hdl.handle.net/10294/14680).
- Mental health disorder prevalence rates at T1 for both groups, based on clinical interviews, or screening tools based on self-reported symptoms, will be comparable to the mental health disorder prevalence rates of the general population (i.e. 10.1%).
- At T1, both groups will report individual difference scores comparable to the general population.
- From T1 to T2, both groups will show reductions in variables associated with risk (e.g. anxiety sensitivity), increases in variables associated with resilience (e.g. distress tolerance), improvements in mental health (e.g. absolute, statistically significant or clinically significant reductions in self-reported symptoms of PTSI, reductions in proportions of participants meeting diagnostic criteria using either standardized cut-off scores, clinical interview results), as a function of the Cadet Training Program.
- The ATC group will, but the STC participants will not, show statistically significant changes associated with more than small effect sizes.
- Relative to the STC group, the ATC group at T2 will report statistically lower risk, greater resilience and better mental health.
- Both groups will show statistically significant predictive relationships between completing assessments, changes to individual differences over time (i.e. inversely with risk [e.g. anxiety sensitivity], positively with resilience [e.g. hope], inversely with mental health symptoms [e.g. symptoms of major depressive disorder]) and successful completion of the Cadet Training Program.
- Both groups will evidence statistically significant sequential predictive relationships for environmental factors or individual differences reported during the daily, monthly and full assessments.
- Both groups will show increases in risk, decreases in resilience and reductions in mental health at T3, T4, T5, T6, and T7, relative to T2; however, the ATC group will show slower increases in risk, slower decreases in resilience and slower reductions in mental health.
- Both groups will show a statistically significant relationship between changes in environmental factors or individual differences over time, frequency of exercise109 and other self-reported indicators of physical health.
- Relative to the STC group, the ATC group will report fewer symptoms of and instances of mental health disorders after T1.
- The ATC group will show a statistically significant relationship between changes in environmental factors or individual differences over time and engagement with ATC content.
- Relative to men, women will report more difficulties with mental disorder symptoms and occupational stressors.
- Changes in biological variables (i.e. autonomic nervous system reactivity, heart rate variability, cardiac mechanical changes) will be associated with environmental factors or individual differences.
The RCMP Study has been designed as an applied longitudinal prospective sequential experimental cohort research project. Participants, the RCMP as an organization, past, present and future RCMP and all PSP should benefit directly and indirectly from the RCMP Study. The benefits should occur irrespective of any specific RCMP Study component (i.e. risk variables, resilience variables, biological variables, the relative impact of the ATC). Through the RCMP Study, the RCMP have become global leaders in the international efforts to better support the mental health of all PSP. The current protocol paper provides details to inform and support similar efforts by other researchers.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The RCMP Study necessarily uses a longitudinal prospective sequential experimental cohort design to create a clustered randomized trial that engages individual participants for 5.5 years. The structure of the Cadet Training Program does not allow for randomizing individual participants or individual groups of participants; nevertheless, meta-analytic evidence suggests that results from studies using this design and results from true randomized controlled trials do not typically differ meaningfully or statistically significantly, and both methods produce comparable groups at baseline.
| Arm | Type | Receives |
|---|---|---|
| Standard Training Condition (STC) | Active comparator | Behavioral: Active MonitoringThe STC has received the "standard" RCMP Depot Division ("Depot") Cadet Training Program as has been provided to cadets prior to June 2022. The STC and the ATC will complete the same standardized self-report assessments, clinical interview assessments, and biometric assessments, and receive the same feedback and reporting based on those assessments. |
| Augmented Training Condition (ATC) | Experimental | Behavioral: Emotional Resilience Skills Training (ERST)The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) is an evidence-based cognitive-behavioral intervention designed to cultivate constructive approach-oriented emotional engagement. The 13-week Emotional Resilience Training (ERST) is an adaptation of the UP designed for use as a proactive training course. The ERST frames emotional experiences as natural responses to threat, rather than pathological occurrences to avoid; as such, the ERST is well-suited for mitigating health challenges and the skills may also help PSP to support persons in distress, including other PSP and the community members they all serve. The ERST training materials include an instructor guide, didactic PowerPoints, and a trainee workbook. The ERST was designed for seamless integration with the Cadet Training Program, effective June 2022, which is what creates the augmented training arm (i.e., the ATC). |
Who may qualify
- Ages
- 19 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Cadets starting the RCMP Cadet Training Program
Key exclusion criteria (1 listed)
- Anyone other than cadets starting the RCMP Cadet Training Program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Resilience Skills Training (ERST)Also: Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP)The ERST training is designed as a "train the trainer" model. Sauer-Zavala, a co-developer of the UP, personally trained a group of RCMP trainers during a week-long interactive workshop. The trainers continue to have access to Sauer-Zavala for optional follow-up consultation and support related to delivery of the ERST training for questions or to address any issues that arise during training. Having consultation and support available for the trainers should help to offset concerns raised about ensuring training fidelity subsequent to other mental health programs. Participants have ongoing access to ERST to support skill retention after training is completed, which should help to offset previous indications of problems with skill development for mental health programs. | Behavioural | Augmented Training Condition (ATC) |
| Active MonitoringParticipants in the STC will be assessed for at least 66 months, via full assessments (i.e., self-report surveys, clinical interviews), monthly assessments (i.e., ~20 minute self-report surveys), daily assessments (i.e., ~1 minute self-report surveys), and biometric assessments. The self-monitoring and feedback should be inherently beneficial and should facilitate earlier access to evidence-based care, which is why the STC is considered an active comparator. | Behavioural | Standard Training Condition (STC) |
Primary outcome
Change in Posttraumatic Stress Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 26)
Time frame: Time 1 (pre-training; week 1), Time 2 (post-training; week 26)
Posttraumatic Stress Disorder Checklist Version 5; Total scores range from 0 to 80; Higher scores indicate more severe symptoms.
Sustained Posttraumatic Stress Disorder Symptoms from Time 2 (post-training; week 26) to Time 7 (5-year follow-up)
Time frame: Time 2 (post-training; week 26), Time 3 (1-year follow-up), Time 4 (2-year follow-up), Time 5 (3-year follow-up), Time 6 (4-year follow-up), Time 7 (5-year follow-up)
Posttraumatic Stress Disorder Checklist Version 5; Total scores range from 0 to 80; Higher scores indicate more severe symptoms.
Change in Major Depressive Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 26)
Time frame: Time 1 (pre-training; week 1), Time 2 (post-training; week 26)
Patient Health Questionnaire - 9 (PHQ-9); Total scores range from 0 to 36; Higher scores indicate more severe symptoms.
Sustained Major Depressive Disorder Symptoms from Time 2 (post-training; week 26) to Time 7 (5-year follow-up)
Time frame: Time 2 (post-training; week 26), Time 3 (1-year follow-up), Time 4 (2-year follow-up), Time 5 (3-year follow-up), Time 6 (4-year follow-up), Time 7 (5-year follow-up)
Patient Health Questionnaire - 9 (PHQ-9); Total scores range from 0 to 36; Higher scores indicate more severe symptoms.
Change in Generalized Anxiety Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 26)
Time frame: Time 1 (pre-training; week 1), Time 2 (post-training; week 26)
Generalized Anxiety Disorder Scale - 7 (GAD-7); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
Sustained Generalized Anxiety Disorder Symptoms from Time 2 (post-training; week 26) to Time 7 (5-year follow-up)
Time frame: Time 2 (post-training; week 26), Time 3 (1-year follow-up), Time 4 (2-year follow-up), Time 5 (3-year follow-up), Time 6 (4-year follow-up), Time 7 (5-year follow-up)
Generalized Anxiety Disorder Scale - 7 (GAD-7); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
Change in Panic Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 26)
Time frame: Time 1 (pre-training; week 1), Time 2 (post-training; week 26)
Panic Disorder Severity Scale (PDSS); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
Sustained Panic Disorder Symptoms from Time 2 (post-training; week 26) to Time 7 (5-year follow-up)
Time frame: Time 2 (post-training; week 26), Time 3 (1-year follow-up), Time 4 (2-year follow-up), Time 5 (3-year follow-up), Time 6 (4-year follow-up), Time 7 (5-year follow-up)
Panic Disorder Severity Scale (PDSS); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 35993603Carleton RN, Kratzig GP, Sauer-Zavala S, Neary JP, Lix LM, Fletcher AJ, Afifi TO, Brunet A, Martin R, Hamelin KS, Teckchandani TA, Jamshidi L, Maguire KQ, Gerhard D, McCarron M, Hoeber O, Jones NA, Stewart SH, Keane TM, Sareen J, Dobson K, Asmundson GJG. The Royal Canadian Mounted Police (RCMP) Study: protocol for a prospective investigation of mental health risk and resilience factors. Health Promot Chronic Dis Prev Can. 2022 Aug;42(8):319-333. doi: 10.24095/hpcdp.42.8.02.
- Derived from this study: PubMed 37008880Khoury JMB, Jamshidi L, Shields RE, Nisbet J, Afifi TO, Fletcher AJ, Stewart SH, Asmundson GJG, Sauer-Zavala S, Kratzig GP, Carleton RN. Putative risk and resiliency factors among Royal Canadian Mounted Police cadets. Front Psychol. 2023 Mar 15;14:1048573. doi: 10.3389/fpsyg.2023.1048573. eCollection 2023.
- RCMP Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. There are ethical and privacy concerns with respect to sharing the participant data, even after anonymization; as such, requests to access the datasets should be directed to the primary investigator and will be addressed on a case-by-case basis in connection with the University of Regina Research Ethics Board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
R. Nicholas Carleton, PhD principal investigator
University of Regina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Resilience Skills Training (ERST) and Active Monitoring in people with Posttraumatic Stress Disorder and Major Depressive Disorder, run by University of Regina at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact R. Nicholas Carleton, PhD (306-337-2387, nick.carleton@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Posttraumatic Stress Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 26) (time frame: Time 1 (pre-training; week 1), Time 2 (post-training; week 26)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05527509, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.