Mental Health Research Study Seeks Adults Experiencing Nightmares
Research Center: NCIRE-The Veterans Health Research Institute and the San Francisco VA Medical Center
Location: This research study can be done from your home within the state of California
Lead Researcher: Anne Richards, M.D., M.P.H.
IRB Committee: This study has also been reviewed and approved by the San Francisco VA Medical Center.
According to the United States Department of Veterans Affairs, having trouble sleeping and experiencing nightmares can be two symptoms of Post-Traumatic Stress Disorder (PTSD). PTSD is a leading health care concern in service members, Veterans, other Department of Defense beneficiaries, as well as the general public. Researchers seek to provide better treatment options for those who experience nightmares, sleep disturbance, and overall symptom burden due to PTSD.
This research study is called REST. It explores the effectiveness of an FDA-approved medication called doxazosin on sleep and PTSD symptoms, including nightmares. Existing research shows that this medication may effectively treat sleep problems, nightmares, and other PTSD symptoms. However, there is still a need for better studies to demonstrate that this medication is effective for PTSD treatment.
Interested participants must be aged 18 to 60 years old and have symptoms of PTSD and experience nightmares. Participants must be willing to comply with the necessary study requirements. Compensation will be provided to eligible participants depending on which phase of the study they complete.
- You may experience a reduction in the severity and frequency of your nightmares, an improvement in your sleep, and a potential reduction in other PTSD symptoms.
- You may help researchers learn more about the effects of this potential treatment on sleep.
- You may contribute valuable information that may benefit others with PTSD and sleep problems related to PTSD in the future.
- You will be compensated up to $530 for participating in this study, depending on which phase of the study you complete.
- You will be helping to advance medical and mental health research.
- If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.
- Your records relating to this study and any other information received will be kept strictly confidential, except as required by law.
- Qualified health professionals will monitor your health as it relates to the study.
Who Can Participate?
- Adults aged 18 to 60 years old who have symptoms of PTSD and are experiencing nightmares related to a traumatic event.
- This study is inviting those who are U.S. Military Veterans.
- Must not have a psychiatric disorder with symptoms of psychosis or a manic episode within the last 5 years.
- This research study will take about 9.5 weeks to complete. There may be 1 study visit at the research site or partnered laboratory site near the participant depending on their location. However, participants will be given the option to participate remotely in study visits. If they choose this option, 1 or more home visits by study staff may be required in order to set up video conferencing equipment. All video conferencing equipment is expected to be returned at the end of your study participation. Permission from the study doctor is needed for remote participation.
- Some study requirements include but are not limited to:
- Completing questionnaires and surveys.
- Completing daily sleep diary entries through an app that will be downloaded into the participant’s electronic device (i.e., smartphone).
- Wearing a monitoring device, called an actigraph, which will measure wrist movement during wake and sleep. Participants may be asked to wear this device on their wrist, like a watch, at all times for 7 days and 7 nights, except during bathing, at three timepoints during the study.
- This study may involve the study staff reviewing medical records, having at-home sleep apnea screening, Laboratory tests, and EKG readings (if needed).
Please note that any study materials that would be mailed to the participants and would be needed back, the study team will include a prepaid return mailer. Participants may have to drop off packages to send back to the study team at their local UPS, FedEx, USPS, etc.
About the Research Center:
NCIRE – The Veterans Health Research Institute
Since 1988, NCIRE-supported scientists and clinicians have been at the front lines of Veterans health research, developing novel treatments for the wide range of conditions that affect Veterans of all ages. They support over 200 researchers who have joint faculty appointments at University of California San Francisco (UCSF) and San Francisco VA (SFVA) Medical Center. Their broad portfolio of projects receives generous support from the National Institutes of Health, the Department of Defense, and individual donors, making them the leading nonprofit research institute devoted to Veterans health in the U.S. Their goals are to continue to advance science, promote education, and foster innovation through leadership in the field of Veterans health research.
Due to the current situation with the COVID-19 pandemic, the researchers would like to assure the participants that ensuring the safety of the participants as well as the study staff is of utmost importance.