Posttraumatic Stress DisorderNCT05530642
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
A study testing Emotional Resilience Skills Training (ERST) in people with Posttraumatic Stress Disorder and Major Depressive Disorder, run by University of Regina at 1 site in Canada.
Trial summary
Public safety personnel (PSP; e.g., border services personnel, correctional workers, firefighters, paramedics, police, public safety communicators) are frequently exposed to potentially psychologically traumatic events. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy 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)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteCanada
- Study dates
- 22 Sep 2020to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently serving PSP firefighters, municipal police officers, paramedics, and public safety communicators
- Potential participants were Canadian citizens or permanent residents
- 18 years or older
- Fluently read, write, and speak either English or French
- Employed in their PSP sector for a minimum of three years
- Access to a computer with internet service
Who cannot join
- High risk of suicide or previous suicide attempt/hospitalization within the prior year
- Currently experiencing psychosis, mania
- Currently experiencing impairing drug or alcohol addictions
- Current or ongoing performance management concerns
- Any history of advocating against mental health care
Trial locations and contacts
1 site in 1 country.
About this study
Public safety personnel (PSP; e.g., border services personnel, correctional workers, firefighters, paramedics, police, public safety communicators) are frequently exposed to potentially psychologically traumatic events. Such events contribute to substantial and growing challenges from posttraumatic stress injuries (PTSIs), including but not limited to posttraumatic stress disorder. The PSP PTSI Study has been designed to evaluate an evidence-informed, proactive system of mental health assessment and training among Royal Canadian Mounted Police (www.rcmpstudy.ca) for delivery among diverse PSP (i.e., firefighters, municipal police, paramedics, public safety communicators). The training is based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders, adapted for PSP, and named Emotional Resilience Skills Training (ERST). The subsequent PSP PTSI Study results are expected to benefit the mental health of all participants and, ultimately, all PSP.
Read the detailed description
Public safety personnel (PSP; e.g., border services personnel, correctional workers, firefighters, paramedics, police, public safety communicators) are frequently exposed to potentially psychologically traumatic events. Such events contribute to substantial and growing challenges from posttraumatic stress injuries (PTSIs), including but not limited to posttraumatic stress disorder. The PSP PTSI Study has been designed to evaluate an evidence-informed, proactive system of mental health assessment and training among Royal Canadian Mounted Police (www.rcmpstudy.ca) for delivery among diverse PSP (i.e., firefighters, municipal police, paramedics, public safety communicators). The training is based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders, adapted for PSP, and named Emotional Resilience Skills Training (ERST). Specifically, the PSP PTSI Study will: 1) adapt, implement, and assess the impact of a system for ongoing (i.e., annual, monthly, daily) evidence-based assessments; 2) evaluate associations between demographic variables and PTSI; 3) longitudinally assess individual differences associated with PTSI; and, 4) assess the impact of providing diverse PSP with a tailored version of the ERST originally developed for the Royal Canadian Mounted Police in mitigating PTSIs based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders. Participants are assessed at pre-training; week 1 (i.e., Time 1) and post-training; week 13 (i.e., Time 2), and then at a 1-year follow-up after training, during week 65 (Time 3). The assessments include clinical interviews, self-report surveys including brief daily and monthly assessments, and daily biometric data. The PSP PTSI Study hypotheses were pre-registered with aspredicted.org for the PSP PTSI Study and associated hypotheses occurred on March 7, 2022 with the name, "An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel" (#90136). Hypotheses specific to individual difference variables are publicly available; however, the overarching PSP PTSI Study hypotheses are: 1) participant mental health disorder prevalence at Time 1, based on Clinical Interviews or screening tools based on self-reported symptoms, will be higher than would be expected for the general population; 2) from Time 1 to Time 2, participants will evidence reductions in risk, increases in resiliency, and improvements in mental health, as a function of the ERST; 3) participants will evidence statistically significant predictive relationships between completing assessments and changes to individual differences over time (i.e., inversely with risk, positively with resilience, positively with mental health); 4) participants will evidence statistically significant sequential predictive relationships for environmental factors or individual differences reported during the Daily Assessments, Monthly Assessments, and Full Assessments; 5) all participants will evidence sustained reductions in risk, increases in resilience, and increases in mental health at Time 3 relative to Time 2; 6) participants will evidence a statistically significant relationship between changes in individual differences over time and engagement with ERST content; 7) participants will evidence a statistically significant relationship between changes in environmental factors or individual differences over time, frequency of exercise, and other self-reported indicators of physical health; 8) relative to men, women will report more difficulties with mental disorder symptoms and occupational stressors; 9) diastole will be reduced in PSP who report symptoms consistent with one or more PTSI; 10) the biometric data will be statistically significantly and substantively correlated with measures of PTSI; 11) there will be a statistically significant and substantive relationship between PTSI symptom severity and reduced diastolic function; and 12) 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 subsequent PSP PTSI Study results are expected to benefit the mental health of all participants and, ultimately, all PSP.
- Conditions
- Posttraumatic Stress Disorder, Major Depressive Disorder, Panic Disorder, Generalized Anxiety Disorder, Trauma, Traumatic Stress Disorder
- Being tested
- Emotional Resilience Skills Training (ERST)
- 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 The 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 PSP trainers from each of the PSP pilot sectors (i.e., CanOps, Regina Fire \& Protective Services, Regina Police Service, Saskatoon Police Service, Regina Emergency Medical Services, Ottawa Emergency Medical Services) 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.
| Study group | Role | What they receive |
|---|---|---|
| Emotional Resilience Skills Training (ERST) | 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. 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 13)
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 13)
Sustained Posttraumatic Stress Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)
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 13), Time 3 (1-year follow-up; week 65)
Change in Major Depressive Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)
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 13)
Sustained Major Depressive Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)
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 13), Time 3 (1-year follow-up; week 65)
Change in Generalized Anxiety Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)
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 13)
Sustained Generalized Anxiety Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)
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 13), Time 3 (1-year follow-up; week 65)
Change in Panic Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)
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 13)
Sustained Panic Disorder Symptoms from Time 2 (post-training; week 13) to Time 3 (1-year follow-up; week 65)
Panic Disorder Severity Scale (PDSS); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
Measured: Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start22 Sep 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The PSP PTSI Study uses a longitudinal prospective sequential experimental cohort design that engages each participant for approximately 16 months. Several practical constraints prohibited a randomized controlled trial, including resource limitations and probable interactions between PSP during and after training.
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Institute for Public Safety Research and Treatment, Saskatchewan Ministry of Justice and Attorney General, Association of Public Safety Communication Officials, Frontenac Paramedic Services, Ottawa Paramedic Service, Paramedic Services Chiefs of Saskatchewan, Peterborough County-City Paramedics, Regina Fire and Protective Services, Saskatchewan Association of Chiefs of Police, Saskatchewan Federation of Police Officers, Saskatchewan Health Authority - Regina Area
- Responsible party
- Sponsor
- Investigators
- R. Nicholas Carleton, PhD, Principal investigator, University of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530642
- Sponsor's protocol ID
- 2020-226
- Status last verified
- Nov 2023
- First submitted
- 29 Aug 2022
- Last updated
- 4 Dec 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 35993603Nisbet J, Maguire KQ, Teckchandani TA, Shields RE, Andrews KL, Afifi TO, Brunet A, Keane TM, Kratzig GP, MacPhee RS, Martin RR, McCarron MCE, Neary JP, Sauer-Zavala S, Carleton RN. Suicidal Ideation, Planning, and Attempts Changes Among Diverse Canadian Public Safety Personnel After the Emotional Resilience Skills Training. Suicide Life Threat Behav. 2025 Feb;55(1):e13168. doi: 10.1111/sltb.13168.
PubMed 39927828Carleton RN, Sauer-Zavala S, Teckchandani TA, Maguire KQ, Jamshidi L, Shields RE, Afifi TO, Nisbet J, Andrews KL, Stewart SH, Fletcher AJ, Martin R, MacPhee RS, MacDermid JC, Keane TM, Brunet A, McCarron M, Lix LM, Jones NA, Kratzig GP, Neary JP, Anderson G, Ricciardelli R, Cramm H, Sareen J, Asmundson GJG. Mental health disorder symptom changes among public safety personnel after emotional resilience skills training. Compr Psychiatry. 2025 Apr;138:152580. doi: 10.1016/j.comppsych.2025.152580. Epub 2025 Feb 5.
PubMed 39923735Carleton RN, McCarron M, Kratzig GP, Sauer-Zavala S, Neary JP, Lix LM, Fletcher AJ, Camp RD 2nd, Shields RE, Jamshidi L, Nisbet J, Maguire KQ, MacPhee RS, Afifi TO, Jones NA, Martin RR, Sareen J, Brunet A, Beshai S, Anderson GS, Cramm H, MacDermid JC, Ricciardelli R, Rabbani R, Teckchandani TA, Asmundson GJG. Assessing the impact of the Royal Canadian Mounted Police (RCMP) protocol and Emotional Resilience Skills Training (ERST) among diverse public safety personnel. BMC Psychol. 2022 Dec 9;10(1):295. doi: 10.1186/s40359-022-00989-0.
PubMed 36494748
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
- ClinicalTrials.gov ID
- NCT05530642
- Acronym / sponsor ID
- 2020-226
- Conditions
- Posttraumatic Stress Disorder, Major Depressive Disorder, Panic Disorder, Generalized Anxiety Disorder, Trauma, Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Canadian Institute for Public Safety Research and Treatment, Saskatchewan Ministry of Justice and Attorney General, Association of Public Safety Communication Officials, Frontenac Paramedic Services, Ottawa Paramedic Service, Paramedic Services Chiefs of Saskatchewan, Peterborough County-City Paramedics, Regina Fire and Protective Services, Saskatchewan Association of Chiefs of Police, Saskatchewan Federation of Police Officers, Saskatchewan Health Authority - Regina Area
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 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.
Public safety personnel (PSP; e.g., border services personnel, correctional workers, firefighters, paramedics, police, public safety communicators) are frequently exposed to potentially psychologically traumatic events. Such events contribute to substantial and growing challenges from posttraumatic stress injuries (PTSIs), including but not limited to posttraumatic stress disorder. The PSP PTSI Study has been designed to evaluate an evidence-informed, proactive system of mental health assessment and training among Royal Canadian Mounted Police (www.rcmpstudy.ca) for delivery among diverse PSP (i.e., firefighters, municipal police, paramedics, public safety communicators). The training is based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders, adapted for PSP, and named Emotional Resilience Skills Training (ERST). The subsequent PSP PTSI Study results are expected to benefit the mental health of all participants and, ultimately, all PSP.
Detailed description
Public safety personnel (PSP; e.g., border services personnel, correctional workers, firefighters, paramedics, police, public safety communicators) are frequently exposed to potentially psychologically traumatic events. Such events contribute to substantial and growing challenges from posttraumatic stress injuries (PTSIs), including but not limited to posttraumatic stress disorder. The PSP PTSI Study has been designed to evaluate an evidence-informed, proactive system of mental health assessment and training among Royal Canadian Mounted Police (www.rcmpstudy.ca) for delivery among diverse PSP (i.e., firefighters, municipal police, paramedics, public safety communicators). The training is based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders, adapted for PSP, and named Emotional Resilience Skills Training (ERST). Specifically, the PSP PTSI Study will: 1) adapt, implement, and assess the impact of a system for ongoing (i.e., annual, monthly, daily) evidence-based assessments; 2) evaluate associations between demographic variables and PTSI; 3) longitudinally assess individual differences associated with PTSI; and, 4) assess the impact of providing diverse PSP with a tailored version of the ERST originally developed for the Royal Canadian Mounted Police in mitigating PTSIs based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders. Participants are assessed at pre-training; week 1 (i.e., Time 1) and post-training; week 13 (i.e., Time 2), and then at a 1-year follow-up after training, during week 65 (Time 3). The assessments include clinical interviews, self-report surveys including brief daily and monthly assessments, and daily biometric data. The PSP PTSI Study hypotheses were pre-registered with aspredicted.org for the PSP PTSI Study and associated hypotheses occurred on March 7, 2022 with the name, "An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel" (#90136). Hypotheses specific to individual difference variables are publicly available; however, the overarching PSP PTSI Study hypotheses are: 1) participant mental health disorder prevalence at Time 1, based on Clinical Interviews or screening tools based on self-reported symptoms, will be higher than would be expected for the general population; 2) from Time 1 to Time 2, participants will evidence reductions in risk, increases in resiliency, and improvements in mental health, as a function of the ERST; 3) participants will evidence statistically significant predictive relationships between completing assessments and changes to individual differences over time (i.e., inversely with risk, positively with resilience, positively with mental health); 4) participants will evidence statistically significant sequential predictive relationships for environmental factors or individual differences reported during the Daily Assessments, Monthly Assessments, and Full Assessments; 5) all participants will evidence sustained reductions in risk, increases in resilience, and increases in mental health at Time 3 relative to Time 2; 6) participants will evidence a statistically significant relationship between changes in individual differences over time and engagement with ERST content; 7) participants will evidence a statistically significant relationship between changes in environmental factors or individual differences over time, frequency of exercise, and other self-reported indicators of physical health; 8) relative to men, women will report more difficulties with mental disorder symptoms and occupational stressors; 9) diastole will be reduced in PSP who report symptoms consistent with one or more PTSI; 10) the biometric data will be statistically significantly and substantively correlated with measures of PTSI; 11) there will be a statistically significant and substantive relationship between PTSI symptom severity and reduced diastolic function; and 12) 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 subsequent PSP PTSI Study results are expected to benefit the mental health of all participants and, ultimately, all PSP.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The PSP PTSI Study uses a longitudinal prospective sequential experimental cohort design that engages each participant for approximately 16 months. Several practical constraints prohibited a randomized controlled trial, including resource limitations and probable interactions between PSP during and after training.
| Arm | Type | Receives |
|---|---|---|
| Emotional Resilience Skills Training (ERST) | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Currently serving PSP firefighters, municipal police officers, paramedics, and public safety communicators
- Potential participants were Canadian citizens or permanent residents
- 18 years or older
- Fluently read, write, and speak either English or French
- Employed in their PSP sector for a minimum of three years
Key exclusion criteria (5 listed)
- High risk of suicide or previous suicide attempt/hospitalization within the prior year
- Currently experiencing psychosis, mania
- Currently experiencing impairing drug or alcohol addictions
- Current or ongoing performance management concerns
- Any history of advocating against mental health care
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: The 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 PSP trainers from each of the PSP pilot sectors (i.e., CanOps, Regina Fire \& Protective Services, Regina Police Service, Saskatoon Police Service, Regina Emergency Medical Services, Ottawa Emergency Medical Services) 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 | Emotional Resilience Skills Training (ERST) |
Primary outcome
Change in Posttraumatic Stress Disorder Symptoms from Time 1 (pre-training; week 1) to Time 2 (post-training; week 13)
Time frame: Time 1 (pre-training; week 1), Time 2 (post-training; week 13)
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 13) to Time 3 (1-year follow-up; week 65)
Time frame: Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)
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 13)
Time frame: Time 1 (pre-training; week 1), Time 2 (post-training; week 13)
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 13) to Time 3 (1-year follow-up; week 65)
Time frame: Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)
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 13)
Time frame: Time 1 (pre-training; week 1), Time 2 (post-training; week 13)
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 13) to Time 3 (1-year follow-up; week 65)
Time frame: Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)
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 13)
Time frame: Time 1 (pre-training; week 1), Time 2 (post-training; week 13)
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 13) to Time 3 (1-year follow-up; week 65)
Time frame: Time 2 (post-training; week 13), Time 3 (1-year follow-up; week 65)
Panic Disorder Severity Scale (PDSS); Total scores range from 0 to 28; Higher scores indicate more severe symptoms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 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 39927828Nisbet J, Maguire KQ, Teckchandani TA, Shields RE, Andrews KL, Afifi TO, Brunet A, Keane TM, Kratzig GP, MacPhee RS, Martin RR, McCarron MCE, Neary JP, Sauer-Zavala S, Carleton RN. Suicidal Ideation, Planning, and Attempts Changes Among Diverse Canadian Public Safety Personnel After the Emotional Resilience Skills Training. Suicide Life Threat Behav. 2025 Feb;55(1):e13168. doi: 10.1111/sltb.13168.
- Derived from this study: PubMed 39923735Carleton RN, Sauer-Zavala S, Teckchandani TA, Maguire KQ, Jamshidi L, Shields RE, Afifi TO, Nisbet J, Andrews KL, Stewart SH, Fletcher AJ, Martin R, MacPhee RS, MacDermid JC, Keane TM, Brunet A, McCarron M, Lix LM, Jones NA, Kratzig GP, Neary JP, Anderson G, Ricciardelli R, Cramm H, Sareen J, Asmundson GJG. Mental health disorder symptom changes among public safety personnel after emotional resilience skills training. Compr Psychiatry. 2025 Apr;138:152580. doi: 10.1016/j.comppsych.2025.152580. Epub 2025 Feb 5.
- Derived from this study: PubMed 36494748Carleton RN, McCarron M, Kratzig GP, Sauer-Zavala S, Neary JP, Lix LM, Fletcher AJ, Camp RD 2nd, Shields RE, Jamshidi L, Nisbet J, Maguire KQ, MacPhee RS, Afifi TO, Jones NA, Martin RR, Sareen J, Brunet A, Beshai S, Anderson GS, Cramm H, MacDermid JC, Ricciardelli R, Rabbani R, Teckchandani TA, Asmundson GJG. Assessing the impact of the Royal Canadian Mounted Police (RCMP) protocol and Emotional Resilience Skills Training (ERST) among diverse public safety personnel. BMC Psychol. 2022 Dec 9;10(1):295. doi: 10.1186/s40359-022-00989-0.
- PSP PTSI Study WebsiteLink provided by the sponsor.
- 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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Major Depression
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
Recruiting
Exercise and Emotional Learning in Posttraumatic Stress Disorder
PTSD
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. This study is not recruiting at the moment.
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) 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 13) (time frame: Time 1 (pre-training; week 1), Time 2 (post-training; week 13)). 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 NCT05530642, which also lists 4 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 4 Dec 2023.