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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02417051
Other study ID # 1-HITEP-140021-01-00
Secondary ID
Status Completed
Phase N/A
First received April 10, 2015
Last updated December 15, 2016
Start date April 2015
Est. completion date November 2016

Study information

Verified date December 2016
Source Stony Brook University
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Institutional Review Board
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 202
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Disaster Worker Resiliency Training
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.

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Stony Brook University Department of Health and Human Services, Northwell Health, Rutgers University

References & Publications (5)

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. — View Citation

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation

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.

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. — View Citation

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived Stress Perceived Stress Scale (PSS; Cohen, Karmarck, and Mermelstein, 1983). 3 months post-intervention No
Secondary Post-Traumatic Stress Disorder Symptoms PTSD Checklist for DSM-5 (PCL-5; Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013). 3 months post-intervention No
Secondary Depression Symptoms Patient Health Questionnaire-9 (PHQ-9; Spitzer, Kroenke, & Williams, 1999). 3 months post-intervention No
Secondary Mental Illness Stigma Attitudes Towards Mental Illness Questionnaire (ATMIQ). 3 months post-intervention No
Secondary Attitudes Towards Seeking Professional Help Attitudes Towards Seeking Professional Help Survey (ATSPH; Bacon, Fischer & Farina, 1995). 3 months post-intervention No
Secondary Post-traumatic Growth Post-Traumatic Growth Inventory-Short Form (PTGI-SF; Cann et al., 2010). 3 months post-intervention No
Secondary Health Promoting Behaviors Health Promoting Lifestyles Profile-II (HPLP-II; Walker, Sechrist, & Pender, 1995). 3 months post-intervention No
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