We know that going on deployment comes with the risk of development of Post Traumatic Stress Disorder (PTSD). Ideally we would like to prevent this condition from developing. Stress Inoculation Training (SIT) has been proposed as a method for teaching someone to deal with stress, and it is hoped that such training may lower the risk of developing PTSD.
WHY IS THE STUDY BEING DONE?
The purpose of this study is to explore the effects of stress inoculation training for personnel deploying to a combat zone. The purpose of this study is to evaluate the effectiveness of stress inoculation training on resilience and coping in an effort to reduce combat related stress.
WHO IS ELIGIBLE? Inclusion criteria is as follows: (1) active duty unit member deploying to a combat zone for a minimum of 6 months (2) planned rotation date from the unit is after the end of study data collection, and (3) signed voluntary informed consent is obtained. Individuals who fail to meet the inclusion criteria for the study will be excluded.
HOW LONG WILL YOU BE PARTICIPATING IN THE STUDY?
Your participation in this research project may range from sixty days prior to your deployment to ninety days after your deployment- ranging 6 to 15 months. You may stop participating in this study at any time. The study will include four forty-five minute sessions with a research team member for data collection- one following entry into the study, one during the training, one immediately following return from deployment, and the last one three months after return from deployment. Participants assigned to the control group will be required to attend any training-as-usual (TAU) sessions (data collection will be completed during this session). Those in the experimental group will attend a two-day Stress Inoculation Training (SIT) program and (data collection will take place during the program time).
WHAT IS INVOLVED IN THE STUDY?
Your participation in this study involves attending a training session along with answering written questions on four separate occasions. You will be randomly assigned into one of two groups. This means you will be assigned into one of these groups by chance. It is like flipping a coin. Neither you nor the investigators will be able to choose the group to which you are assigned. If you take part in this study, you will experience one of the following types of training:
Experimental Group will be assigned to the SIT program and will complete a two-day training schedule. Two questionnaires will be completed on the second day of training. Additional questionnaires will be completed upon return from your 6-15 month operational deployment and then again three months post-deployment. Questionnaires will take no longer than 15 minutes each to complete. SIT Group participants will attend a debriefing to assess experiences and if stress reduction support was offered to others in the unit.
Control Group will be assigned to training-as-usual (TAU) which will be facilitated by the study’s research assistant. Two questionnaires will be completed on the second day of training. Additional questionnaires will be completed upon return from operational deployment and again three months post-deployment. Questionnaires will take no longer than 15 minutes each to complete. The TAU consists of two 90 minute online modules of pre-deployment training. The content of TAU does not include any of the SIT content.
WHAT IS THE EXPERIMENTAL PART OF THE STUDY?
Specifically, the experimental part of this research project is your participation in the Stress Inoculation Training course and completion of the questionnaires. The materials for the two-day workshop are from Whole Person Associates, a company which specializes in stress and wellness programs. Content material includes: stress awareness and practice; sleep hygiene and relaxation; coping skills and practice; conflict resolution; anxiety awareness and management; and communication skills. Each participant in the experimental group will be provided with opportunities to practice these newly acquired skills while in the classroom environment.
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
A total of 52 subjects are expected to participate in this study.
WHAT ARE THE RISKS OF THE STUDY?
The possible risks and discomforts associated with study participation in this research project may include discomforting event during the training, an inconvenience of your time, and loss of privacy. Although unlikely, if you experience an awkward or embarrassing event during the training, an offer of counseling will be made, if you desire, you will be escorted to the Emergency Room if you are experiencing severe or significant acute symptoms.
Scores on one of the questionnaires (the Post Traumatic Stress Disorder PTSD Checklist-Military) that total 30 or greater will be reported to either Associate Investigators Dr. McLay or CDR Jonathan Deinard within 72 hours of completion. One of them will in turn contact you and assess any significant symptoms and offer mental health evaluation and/or treatment. You also have an option to decline treatment. If you show any indications of suicidal ideation, homicidal ideation or danger, you will be required to receive mental health evaluation.
This is a greater than minimal risk research project because a list with personal identifiers will be used to link electronic and paper data. A potential risk is that the temporary list used to identify records would be exposed outside of the research team or that the results could be linked to a study participant. Your privacy will be protected. Study procedures will ensure no identifying information will be linked to questionnaires. The master list of individual names and demographic information will be retained in a locked file cabinet. Signed consents will be kept in a separate locked file cabinet. A key/list assigning participants to code numbers/unique subject identifiers will be kept in a third separate file cabinet. Completed questionnaires will be de-identified and participant code numbers/unique subject identifiers will be used, these files will be kept separate from the key/list. All data bases with de-identified data will be password protected. No subject data will contain any individual identifying data. No individual identifiers will be used in the research database or in reporting research results.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
Your participation in this research project may not be of direct benefit to you personally. We hope the information learned from this study will benefit people with combat related stress reactions in the future. Sailors and the Navy will benefit by research that provides information regarding the effects of SIT on operational forces in an effort to improve the force health protection, operational readiness, and improved delivery of health services the U.S. military services.
WILL I BE PAID TO PARTICIPATE?
You will not be financially compensated for your participation in this study.
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