- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06861400
A Digital Resilience Intervention for Emergency Medical Service Workers
March 5, 2025 updated by: Bryce Hruska, Syracuse University
Self-Reflective Resilience-Recovery Activity Promotion Training for Emergency Medical Service Personnel
Emergency medical service (EMS) workers (i.e., ambulance service providers) experience triple the risk for anxiety, depression, and posttraumatic stress disorder (PTSD) compared to the general U.S. population.
These mental disorders impact health and well-being across the life course.
Thus, there is a critical need for interventions targeting key risk factors that can reduce EMS workers' mental health risk.
Chronic stress represents such a risk factor and is a routine feature of the EMS profession due to the demands of providing emergency medical care.
Self-Reflective Resilience-Recovery Activity Promotion Training (SRR-RAPT) promotes finding positive meaning in stressors by building self-awareness of the coping and regulatory responses used to manage them; evaluating those responses; adapting them based upon their perceived effectiveness; and developing a plan for managing similar stressors in the future based on what can be learned from the current situation.
In addition to prompting self-monitoring and active reflection on stressors and coping responses, SRR-RAPT encourages practicing recovery activities that permit a person's stressor induced strain level to return to baseline.
The primary objective of the current study is to evaluate the feasibility, acceptability, and adoptability of SRR-RAPT among EMS personnel.
A secondary objective was to examine the intervention's effect on hypothesized mechanisms of action predicted to vary in response to the intervention, as well as consider the intervention's ability to reduce mental health symptoms.
It is hypothesized that the intervention will be associated with more positive meaning made, adaptive self-reflection, recovery activities, and recovery experiences, as well as lower levels of mental health symptoms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13244
- Syracuse University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Full-time or part-time employee at an emergency medical service agency
- ≥ 18 years of age
- ≥ 1 emergency medical service shift scheduled in the next 8 days from recruitment date.
Exclusion Criteria:
- Not a full-time or part-time employee at an emergency medical service agency
- < 18 years of age
- < 1 emergency medical service shift scheduled in the next 8 days from recruitment date.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-Reflective Resilience-Recovery Activity Promotion Training (SRR-RAPT)
Receives Self-Reflective Resilience-Recovery Activity Promotion Training (SRR-RAPT)
|
Self-Reflective Resilience-Recovery Activity Promotion Training (SRR-RAPT) promotes finding positive meaning in stressors by building self-awareness of the coping and regulatory responses used to manage them; evaluating those responses; adapting them based upon their perceived effectiveness; and developing a plan for managing similar stressors in the future based on what can be learned from the current situation.
In addition to prompting self-monitoring and active reflection on stressors and coping responses, SRR-RAPT encourages practicing recovery activities that permit a person's stressor induced strain level to return to baseline.
SRR-RAPT is administered daily for 8 consecutive days.
|
|
No Intervention: Usual Care
Does not receive SRR-RAPT.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time period required to achieve target sample size
Time Frame: From study initiation until at least 80 participants are recruited, up to 12 months
|
The number of months it takes to recruit the number of participants necessary to reach the target sample size.
|
From study initiation until at least 80 participants are recruited, up to 12 months
|
|
Number of participants recruited and randomized each week of the study
Time Frame: From study initiation until at least 80 participants are recruited, up to 12 months
|
A count of the number of participants who are recruited and randomized each week that the study is taking place.
|
From study initiation until at least 80 participants are recruited, up to 12 months
|
|
Acceptability
Time Frame: Day 8 of the intervention
|
Assessed with 3 items asking about respondents' perceptions that the intervention was helpful ("I found that answering the questions about managing stressful experiences and practicing recovery behaviors was helpful"); useful ("I found that answering the questions about managing stressful experiences and practicing recovery behaviors was useful"); and not burdensome ("I found that answering the questions about managing stressful experiences and practicing recovery behaviors was not too burdensome").
Respondents rated each item on a scale ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree").
Ratings are summed to yield a total daily score.
|
Day 8 of the intervention
|
|
Adoptability
Time Frame: Day 8 of the intervention
|
Assessed with 3 items asking about respondents intention to use what they had learned from the intervention in the future ("I will keep using these questions to help manage stressful experiences and practice recovery activities in the future."
"I will try to use these questions in the future when managing stressful experiences and trying to practice recovery activities."
"I plan to use some of the approaches that I came up with in my responses to the questions about managing stressful experiences and practicing recovery behaviors in the future").
Respondents rate each item on a scale ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree").
Ratings are summed to yield a total daily score.
|
Day 8 of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Meaning Made
Time Frame: Days 1 to 8 of the intervention
|
Assessed using 3 items with the highest factor loadings on the positive reframing, acceptance, and religion subscales of the Brief COPE plus one additional item representing growth ("I identified lessons that I can learn from the challenge").
Respondents rate how much they performed the strategy described in response to any stressful or challenging experiences they encountered today.
Ratings are made on a scale ranging from 1 ("Not at all") to 4 ("I did this a lot").
Ratings are summed to yield a total daily score.
|
Days 1 to 8 of the intervention
|
|
Adaptive Self-Reflection
Time Frame: Days 1 to 8 of the intervention
|
Derived from 3 items used in prior research.
Each day respondents rate how much they agree with the following statements describing how they reacted to challenging and stressful events they encountered today: "I noticed the strategies that I used to cope with today's stress experiences", "I considered how I approach stressful experiences in my life", and "After attempting to deal with any of today's stressful experiences, I thought about how well my approach worked."
Ratings are made on a scale ranging from 1 ("Strongly Disagree") to 5 ("Strongly Agree").
Ratings are summed to yield a total daily score.
|
Days 1 to 8 of the intervention
|
|
Recovery Activities
Time Frame: Days 1 to 8 of the intervention
|
Pittsburgh Enjoyable Activities Test.
For each item, respondents indicate whether they did the activity described today when they were not working ("Yes" vs "No").
Endorsed items are summed to yield a total daily count.
|
Days 1 to 8 of the intervention
|
|
Recovery Experiences
Time Frame: Days 1 to 8 of the intervention
|
Derived from 8 items with the highest factor loadings from the detachment, relaxation, mastery, and control subscales of the Recovery Experiences Questionnaire.
Respondents report how much they agree with each statement describing what they did during their off-job time today on a scale ranging from 1 ("Totally Disagree") to 5 ("Totally Agree").
Ratings are summed to yield a total daily score.
|
Days 1 to 8 of the intervention
|
|
PTSD Symptom Severity
Time Frame: Days 1 to 8 of the intervention
|
Short -form of the PTSD Checklist for DSM-5.
Each day respondents rate how bothered they are by PTSD symptoms on a scale ranging from 0 ("Not at all") to 4 ("Extremely").
Ratings are summed to yield a total daily score.
|
Days 1 to 8 of the intervention
|
|
Depression Symptom Severity
Time Frame: Days 1 to 8 of the intervention
|
PROMIS-dep-4a questionnaire.
Each day respondents rate the extent they experienced depression symptoms on a scale ranging from 1 ("Not at all") to 5 ("All of the time").
Ratings are summed to yield a total daily score.
|
Days 1 to 8 of the intervention
|
|
Anxiety Symptom Severity
Time Frame: Days 1 to 8 of the intervention
|
PROMIS-anx-4a questionnaire.
Each day respondents rate the extent they experienced anxiety symptoms on a scale ranging from 1 ("Not at all") to 5 ("All of the time").
Ratings are summed to yield a total daily score.
|
Days 1 to 8 of the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
- Pressman SD, Matthews KA, Cohen S, Martire LM, Scheier M, Baum A, Schulz R. Association of enjoyable leisure activities with psychological and physical well-being. Psychosom Med. 2009 Sep;71(7):725-32. doi: 10.1097/PSY.0b013e3181ad7978. Epub 2009 Jul 10.
- Sonnentag S, Fritz C. The Recovery Experience Questionnaire: development and validation of a measure for assessing recuperation and unwinding from work. J Occup Health Psychol. 2007 Jul;12(3):204-21. doi: 10.1037/1076-8998.12.3.204.
- Cella D, Choi SW, Condon DM, Schalet B, Hays RD, Rothrock NE, Yount S, Cook KF, Gershon RC, Amtmann D, DeWalt DA, Pilkonis PA, Stone AA, Weinfurt K, Reeve BB. PROMIS(R) Adult Health Profiles: Efficient Short-Form Measures of Seven Health Domains. Value Health. 2019 May;22(5):537-544. doi: 10.1016/j.jval.2019.02.004.
- Zuromski KL, Ustun B, Hwang I, Keane TM, Marx BP, Stein MB, Ursano RJ, Kessler RC. Developing an optimal short-form of the PTSD Checklist for DSM-5 (PCL-5). Depress Anxiety. 2019 Sep;36(9):790-800. doi: 10.1002/da.22942. Epub 2019 Jul 29.
- Cooper C, Katona C, Livingston G. Validity and reliability of the brief COPE in carers of people with dementia: the LASER-AD Study. J Nerv Ment Dis. 2008 Nov;196(11):838-43. doi: 10.1097/NMD.0b013e31818b504c.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 28, 2023
Primary Completion (Actual)
December 20, 2023
Study Completion (Actual)
December 20, 2023
Study Registration Dates
First Submitted
February 24, 2025
First Submitted That Met QC Criteria
February 28, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 5, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-3278-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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