The purpose of this study is to compare the effectiveness of two psychological treatments for the reduction of suicide attempts among U.S. military personnel and veterans, and to identify the reasons why and how these treatments work.
Specifically, this study is looking at the efficacy of two interventions. The first intervention is Present Centered Therapy (PCT). This treatment has been shown to reduce depression, PTSD symptoms, and suicidal thoughts. The second intervention is Brief Cognitive Behavioral Therapy (BCBT). This treatment has also been shown to reduce depression, PTSD symptoms, and suicidal thoughts.
Both treatments involve a total of 12-16 sessions scheduled once or twice each week. Patients who have received either treatment have reported significant reductions in suicidal thoughts and psychological symptoms. These two treatments differ from each other with respect to the specific procedures and techniques used. The purpose of this study is to determine if one treatment works better than the other, or if they are equal to each other with respect to outcomes.
This study is only open to Veterans at the Ralph H. Johnson VA Health Care System and CBOCs or active duty military personnel in the Charleston, SC and Savannah, GA areas.
By doing this study, we hope to learn if a brief screening method can predict which people are most likely to show a positive response to selective serotonin reuptake inhibitor (SSRI) medications. This brief screening method involves using electrodes attached to your scalp via a cap, to measure electrical brain activity in response to a series of loud tones.
Your participation in this research will last about 17-21 weeks if you decide to stay for the whole study.
Researchers recently developed two new, computer-administered, brief questionnaire assessments of posttraumatic stress disorder (PTSD). The purpose of this study is to determine if these new assessments are accurate by comparing them with existing assessments for PTSD. To do this, we plan to administer the new questionnaires, existing questionnaires, and interview questions to 350 veterans with and without PTSD.
Veterans will be recruited from the Ralph H. Johnson VA Health Care System and Savannah CBOC.
While there are medications for PTSD, they don't treat all the symptoms and only affect the severity of some symptoms instead of reducing symptoms overall. As a result, you may be considering other options for your PTSD.
One option to consider is this clinical research study of an oral investigational drug for adults diagnosed with PTSD. In this study, doctors want to evaluate the safety and effectiveness of the investigational drug and compare it to a placebo, which looks like the investigational drug but contains no active medicine. The investigational drug has been studied in clinical research studies before, but it is not approved to treat PTSD. People with PTSD can only receive the investigational drug in clinical research studies like this one.
The results of this study will provide more information about the
investigational drug and whether it could one day be prescribed to
If you are eligible for this study and agree to participate, you will be randomly assigned (like the flip of a coin) to receive the investigational drug or placebo. You have an equal chance of receiving either study drug (investigational or placebo).
You, the study doctor and the study staff will not know which study drug you are receiving. However, in the event of an emergency, this information can be provided.
You will take your assigned study drug once a day for 8-weeks. You will attend up to 8 study center visits for tests, procedures, interviews, and questionnaires to evaluate your health and PTSD. You will also receive 4 phone or video calls from the study doctor/staff to talk about how you are feeling.
Your total study participation will last approximately 16 weeks, which includes screening for eligibility, study drug dosing, and follow-up.