- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02417051
The Efficacy of a Brief Resilience Training Program for Hurricane Sandy Disaster Responders
December 15, 2016 updated by: Adam Gonzalez, Stony Brook University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
202
Phase
- Not Applicable
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- An inability to comprehend the intervention in English.
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resiliency Training
Intervention: Disaster Worker Resiliency 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.
Other Names:
|
|
No Intervention: Waitlist
Waitlist control: Participants to be offered the program after completion of the trial.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress
Time Frame: 3 months post-intervention
|
Perceived Stress Scale (PSS; Cohen, Karmarck, and Mermelstein, 1983).
|
3 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-Traumatic Stress Disorder Symptoms
Time Frame: 3 months post-intervention
|
PTSD Checklist for DSM-5 (PCL-5; Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013).
|
3 months post-intervention
|
|
Depression Symptoms
Time Frame: 3 months post-intervention
|
Patient Health Questionnaire-9 (PHQ-9; Spitzer, Kroenke, & Williams, 1999).
|
3 months post-intervention
|
|
Mental Illness Stigma
Time Frame: 3 months post-intervention
|
Attitudes Towards Mental Illness Questionnaire (ATMIQ).
|
3 months post-intervention
|
|
Attitudes Towards Seeking Professional Help
Time Frame: 3 months post-intervention
|
Attitudes Towards Seeking Professional Help Survey (ATSPH; Bacon, Fischer & Farina, 1995).
|
3 months post-intervention
|
|
Post-traumatic Growth
Time Frame: 3 months post-intervention
|
Post-Traumatic Growth Inventory-Short Form (PTGI-SF; Cann et al., 2010).
|
3 months post-intervention
|
|
Health Promoting Behaviors
Time Frame: 3 months post-intervention
|
Health Promoting Lifestyles Profile-II (HPLP-II; Walker, Sechrist, & Pender, 1995).
|
3 months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adam Gonzalez, PHD, Stony Brook University
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
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- 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.
- 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.
- 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.
- Weathers, FW., Litz, BT, Keane, TM, Palmieri, PA, Marx, BP, & Schnurr, PP. The PTSD checklist for DSM-5 (PCL-5). National Center for PTSD. 2013.
- Fischer, 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.
Helpful Links
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
April 1, 2015
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
April 10, 2015
First Submitted That Met QC Criteria
April 10, 2015
First Posted (Estimate)
April 15, 2015
Study Record Updates
Last Update Posted (Estimate)
December 16, 2016
Last Update Submitted That Met QC Criteria
December 15, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-HITEP-140021-01-00
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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