Six Ways to Help Manage Staff Trauma Exposure in PTSD Trials

There are currently more than 300 ongoing clinical research studies, mostly in the academic arena, occurring around the world into post-traumatic stress disorder (PTSD) in various populations.

But those with PTSD may not be the only ones’ suffering. The members of the research teams trying to help those with trauma illnesses, like PTSD, need to be considered too. More than two decades of scientific research shows that secondary trauma is a predictable consequence for some clinicians working with traumatized populations.

We’ve been working in PTSD research for some time, including becoming the first CRO to study post-traumatic stress disorder in military veterans. We’ve learned that our research teams conducting this important, life-changing work must be not only be selected based on their experience and merit, but must also be supported properly if trials are going to be successful and index trauma-related research is to continue to advance.

Interested in learning more about PTSD research? Check out our webinar on the nuances of conducting PTSD trials.

Here are six ways to ensure your site study team is appropriately prepared:

  1. Identify and select clinical trial staff that have experience working with PTSD and other trauma-related populations.  Make sure the staff has full support from an experienced behavioral health professional on site. Nurture staff retention and limit turnover, as trust and consistency in staff and participant interaction, are vital in trauma-related trials.
  2. Prepare clinical trial staff for the types of trauma they may be exposed to during a PTSD or trauma-related trial. Provide continuing professional training to improve trial staff’s understanding of trauma, making it clear that not all traumas or one’s reaction to trauma is the same. For example, combat-related trauma and sexual abuse/assault trauma are very different in presentation as well as gender and culturally different.
  3. Provide a safe and comfortable environment for PTSD trials to occur, for both the subject and the study staff. A feeling of safety and trust is vital for trauma subjects’ participation.
  4. Conduct in-house gatherings and consistent clinical and trauma-trained managerial supervision on-site meetings and consistent clinical training focused on trauma:
    • Debrief with team members on a regular basis.
    • Protect staff from secondary trauma effects by providing safe outlets for sharing any emotional distress of working with traumatized individuals and preventing their isolation.
    • Provide a mechanism for staff to meet with the principal investigator and/or medical monitor assigned to the study about what they are experiencing personally being part of a PTSD or trauma-related trial.
  5. Make sure through monitoring, staff care plans, and ongoing feedback sessions, that clinical trial staff maintain a balance between home, work and outside community, and/or spiritual activities.

Support and encourage clinical trial staff to engage in individual counseling or psychotherapy, when needed, to explore personal issues that may increase any likelihood of secondary traumatization at work.

What To Read Next:
7 Ways To Engage Military Vets In PTSD Clinical Trials

Author Details

Denise Bedoya
Ms. Bedoya has over 19 years of extensive experience in the research field, including both pharmaceutical and government sponsored studies as well as CRO experience, with experience across all Phases in the therapeutic areas of Neurology, Pediatrics, and Psychiatry. Her expertise has been gained in such disease states as depression, bipolar disorder, schizophrenia, autism, ADHD, OCD, disruptive behavioral disorders, post-traumatic stress disorder, eating disorders, anxiety, substance abuse, and traumatic brain injury. In addition, Ms. Bedoya has experience with Phase II rare disease trials. Ms. Bedoya has a Master’s of Arts in Clinical/Counseling Psychology, gained in 1998, from Cleveland State University and a Bachelor’s of Arts in Psychology from West Virginia University.
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