Psychological StressNCT02417051
The Efficacy of a Brief Resilience Training Program for Hurricane Sandy Disaster Responders
A study testing Disaster Worker Resiliency Training in people with Psychological Stress, run by Stony Brook University.
Trial summary
The goal of this project is to adapt and test the efficacy of the National Institute of Environmental Health and Safety (NIEHS) Disaster Worker Resilience Training (DWRT) Program for Superstorm Sandy responders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Disaster Worker Resiliency Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Nov 2016
- 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
- Participated as a volunteer or professional in Hurricane Sandy relief efforts.
- Report that they are still an active disaster responder (i.e., they may be called upon to participate in future disaster relief efforts) as either a volunteer or professional.
Who cannot join
- An inability to comprehend the intervention in English.
About this study
The goal of this project is to adapt and test the efficacy of the National Institute of Environmental Health and Safety (NIEHS) Disaster Worker Resilience Training (DWRT) Program for Superstorm Sandy responders. The DWRT is a brief, 4-5 hour training program designed to improve resilience for stress reactions in active emergency responders. A total of 120 participants will be recruited. 60 will receive the DWRT, and 60 will be assigned to a waitlist control condition. A three-month assessment period will be utilized to enable us to evaluate the effects of the intervention. Participants assigned to the waitlist condition will be offered the option to participant in the course following completion of the 3 month wait period. It is hypothesized that, participants attending the DWRT program, as compared to those in the waitlist condition, will show increased resilience at three months post-intervention as indicated by lower perceived stress, greater posttraumatic growth, more positive health behaviors (e.g., sleep, nutrition, exercise), and fewer new PTSD and depression symptoms. It is predicted that participants attending the DWRT program, as compared to those in the waitlist condition, will demonstrate greater awareness of the mental health effects of disasters, including the symptoms of PTSD and depression. It is predicted that, participants attending the DWRT program, as compared to those in the waitlist condition, will endorse more positive attitudes towards mental health care, including willingness to seek treatment if needed.
Read the detailed description
This project is a scientific collaboration between the World Trade Center (WTC) Health Program at Stony Brook University (SBU), the Epidemiology Program at North Shore-LIJ Health System (NSLIJ), and Rutgers University. The goal is to adapt and test the efficacy of the National Institute of Environmental Health and Safety (NIEHS) Disaster Worker Resilience Training (DWRT) Program for Sandy responders by leveraging data from the ongoing projects and the expertise of collaborators at these sites. The DWRT program was originally designed for and piloted with responders to the 2010 Deep Water Horizon oil spill. Knowledge from the ongoing Sandy projects will be used to tailor this intervention to address Sandy-specific risk factors and unique features of the responder communities in the New York Metropolitan area. Responders identified from ongoing projects at SBU (N=1500, 50% anticipated eligible) and other current local disaster responders will be targeted for enrollment. The objectives are to: (1) to adapt the DWRT program for this population; (2) recruit and randomly assign responders (N = 120) to the DWRT program or a waitlist control condition; (3) assess the efficacy of this intervention to enhance resilience over a three month period; and (4) host forums with community stakeholders to share information on this program and its outcomes. The expected outcomes are: (1) efficacy data on the DWRT program, and (2) qualitative data on the acceptability of this intervention to Sandy responders. The products are: (1) a final report; (2) articles for publication; (3) abstracts for national conferences; and (4) a training manual, participant workbook, and presenter materials.
- Conditions
- Psychological Stress
- Being tested
- Disaster Worker Resiliency Training
- Keywords
- Psychological Resilience, Perceived Stress, Psychological Stress, Disaster Worker, Superstorm Sandy, Mental Health, Prevention
- Medical subject headings
- Stress, Psychological, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disaster Worker Resiliency TrainingBehavioural
Also called Disaster Worker Resilience Training (DWRT) Program
The Disaster Worker Resilience Training (DWRT) Program is a 4 hour program which consists of a participant training manual, an instructor-training manual, and a digital presentation. It uses adult training techniques that emphasize active participation in individual and group experiential learning activities. The curriculum is organized into a preface and four chapters, each with action oriented learning objectives. Overall program objectives include a demonstrate an ability to: 1) Recognize signs and symptoms of disaster work-related stress, 2) Obtain support through employer and community resources, and 3) Build resilience by using stress reduction and coping strategies.
| Study group | Role | What they receive |
|---|---|---|
| Resiliency Training | Experimental | Intervention: Disaster Worker Resiliency Training (DWRT) Program. Receives: Behavioral: Disaster Worker Resiliency Training |
| Waitlist | No intervention | Waitlist control: Participants to be offered the program after completion of the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress
Perceived Stress Scale (PSS; Cohen, Karmarck, and Mermelstein, 1983).
Measured: 3 months post-intervention
Secondary outcomes (6)
Post-Traumatic Stress Disorder Symptoms
PTSD Checklist for DSM-5 (PCL-5; Weathers, Litz, Keane, Palmieri, Marx, \& Schnurr, 2013).
Measured: 3 months post-intervention
Depression Symptoms
Patient Health Questionnaire-9 (PHQ-9; Spitzer, Kroenke, \& Williams, 1999).
Measured: 3 months post-intervention
Mental Illness Stigma
Attitudes Towards Mental Illness Questionnaire (ATMIQ).
Measured: 3 months post-intervention
Attitudes Towards Seeking Professional Help
Attitudes Towards Seeking Professional Help Survey (ATSPH; Bacon, Fischer \& Farina, 1995).
Measured: 3 months post-intervention
Post-traumatic Growth
Post-Traumatic Growth Inventory-Short Form (PTGI-SF; Cann et al., 2010).
Measured: 3 months post-intervention
Health Promoting Behaviors
Health Promoting Lifestyles Profile-II (HPLP-II; Walker, Sechrist, \& Pender, 1995).
Measured: 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Psychological StressStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwell Health, Rutgers University, Department of Health and Human Services
- Responsible party
- Principal investigator, Adam Gonzalez, Stony Brook University
- Investigators
- Adam Gonzalez, PhD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417051
- Sponsor's protocol ID
- 1-HITEP-140021-01-00
- Status last verified
- Dec 2016
- First submitted
- 10 Apr 2015
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
PubMed 10568646Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Weathers, FW., Litz, BT, Keane, TM, Palmieri, PA, Marx, BP, & Schnurr, PP. The PTSD checklist for DSM-5 (PCL-5). National Center for PTSD. 2013.
Cann A, Calhoun LG, Tedeschi RG, Taku K, Vishnevsky T, Triplett KN, Danhauer SC. A short form of the Posttraumatic Growth Inventory. Anxiety Stress Coping. 2010;23(2):127-37. doi: 10.1080/10615800903094273.
PubMed 19582640Fischer, Edward H, and Farina, A. Attitudes toward Seeking Professional Psychological Help: A Shortened Form and Considerations for Research. Journal of College Student Development 36(4): 368-73, 1995.
Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.
PubMed 32627860
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Brief Resilience Training Program for Hurricane Sandy Disaster Responders
- ClinicalTrials.gov ID
- NCT02417051
- Acronym / sponsor ID
- 1-HITEP-140021-01-00
- Conditions
- Psychological Stress
- Keywords
- Psychological Resilience, Perceived Stress, Psychological Stress, Disaster Worker, Superstorm Sandy, Mental Health, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Northwell Health, Rutgers University, Department of Health and Human Services
- Study start
- Apr 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 15 Apr 2015 (estimated)
- 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 goal of this project is to adapt and test the efficacy of the National Institute of Environmental Health and Safety (NIEHS) Disaster Worker Resilience Training (DWRT) Program for Superstorm Sandy responders. The DWRT is a brief, 4-5 hour training program designed to improve resilience for stress reactions in active emergency responders. A total of 120 participants will be recruited. 60 will receive the DWRT, and 60 will be assigned to a waitlist control condition. A three-month assessment period will be utilized to enable us to evaluate the effects of the intervention. Participants assigned to the waitlist condition will be offered the option to participant in the course following completion of the 3 month wait period. It is hypothesized that, participants attending the DWRT program, as compared to those in the waitlist condition, will show increased resilience at three months post-intervention as indicated by lower perceived stress, greater posttraumatic growth, more positive health behaviors (e.g., sleep, nutrition, exercise), and fewer new PTSD and depression symptoms. It is predicted that participants attending the DWRT program, as compared to those in the waitlist condition, will demonstrate greater awareness of the mental health effects of disasters, including the symptoms of PTSD and depression. It is predicted that, participants attending the DWRT program, as compared to those in the waitlist condition, will endorse more positive attitudes towards mental health care, including willingness to seek treatment if needed.
Detailed description
This project is a scientific collaboration between the World Trade Center (WTC) Health Program at Stony Brook University (SBU), the Epidemiology Program at North Shore-LIJ Health System (NSLIJ), and Rutgers University. The goal is to adapt and test the efficacy of the National Institute of Environmental Health and Safety (NIEHS) Disaster Worker Resilience Training (DWRT) Program for Sandy responders by leveraging data from the ongoing projects and the expertise of collaborators at these sites. The DWRT program was originally designed for and piloted with responders to the 2010 Deep Water Horizon oil spill. Knowledge from the ongoing Sandy projects will be used to tailor this intervention to address Sandy-specific risk factors and unique features of the responder communities in the New York Metropolitan area. Responders identified from ongoing projects at SBU (N=1500, 50% anticipated eligible) and other current local disaster responders will be targeted for enrollment. The objectives are to: (1) to adapt the DWRT program for this population; (2) recruit and randomly assign responders (N = 120) to the DWRT program or a waitlist control condition; (3) assess the efficacy of this intervention to enhance resilience over a three month period; and (4) host forums with community stakeholders to share information on this program and its outcomes. The expected outcomes are: (1) efficacy data on the DWRT program, and (2) qualitative data on the acceptability of this intervention to Sandy responders. The products are: (1) a final report; (2) articles for publication; (3) abstracts for national conferences; and (4) a training manual, participant workbook, and presenter materials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resiliency Training | Experimental | Behavioral: Disaster Worker Resiliency TrainingIntervention: Disaster Worker Resiliency Training (DWRT) Program. |
| Waitlist | No intervention | –Waitlist control: Participants to be offered the program after completion of the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participated as a volunteer or professional in Hurricane Sandy relief efforts.
- Report that they are still an active disaster responder (i.e., they may be called upon to participate in future disaster relief efforts) as either a volunteer or professional.
Key exclusion criteria (1 listed)
- An inability to comprehend the intervention in English.
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 |
|---|---|---|
| Disaster Worker Resiliency TrainingAlso: Disaster Worker Resilience Training (DWRT) ProgramThe Disaster Worker Resilience Training (DWRT) Program is a 4 hour program which consists of a participant training manual, an instructor-training manual, and a digital presentation. It uses adult training techniques that emphasize active participation in individual and group experiential learning activities. The curriculum is organized into a preface and four chapters, each with action oriented learning objectives. Overall program objectives include a demonstrate an ability to: 1) Recognize signs and symptoms of disaster work-related stress, 2) Obtain support through employer and community resources, and 3) Build resilience by using stress reduction and coping strategies. | Behavioural | Resiliency Training |
Primary outcome
Perceived Stress
Time frame: 3 months post-intervention
Perceived Stress Scale (PSS; Cohen, Karmarck, and Mermelstein, 1983).
6 secondary outcomes
Post-Traumatic Stress Disorder Symptoms
Time frame: 3 months post-intervention
Depression Symptoms
Time frame: 3 months post-intervention
Mental Illness Stigma
Time frame: 3 months post-intervention
Attitudes Towards Seeking Professional Help
Time frame: 3 months post-intervention
Post-traumatic Growth
Time frame: 3 months post-intervention
Health Promoting Behaviors
Time frame: 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Background: PubMed 10568646Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- BackgroundWeathers, FW., Litz, BT, Keane, TM, Palmieri, PA, Marx, BP, & Schnurr, PP. The PTSD checklist for DSM-5 (PCL-5). National Center for PTSD. 2013.
- Background: PubMed 19582640Cann A, Calhoun LG, Tedeschi RG, Taku K, Vishnevsky T, Triplett KN, Danhauer SC. A short form of the Posttraumatic Growth Inventory. Anxiety Stress Coping. 2010;23(2):127-37. doi: 10.1080/10615800903094273.
- BackgroundFischer, Edward H, and Farina, A. Attitudes toward Seeking Professional Psychological Help: A Shortened Form and Considerations for Research. Journal of College Student Development 36(4): 368-73, 1995.
- Derived from this study: PubMed 32627860Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.
- Link to NIEHS Disaster Worker Training Program MaterialsLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Adam Gonzalez, PhD principal investigator
Stony Brook University
Questions about this trial
What is this clinical trial studying?
A study testing Disaster Worker Resiliency Training in people with Psychological Stress, run by Stony Brook University.
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 2 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: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perceived Stress (time frame: 3 months post-intervention). 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 NCT02417051, which also lists 6 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 16 Dec 2016.