Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05881174
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2023-05-19
Brief Title:
Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder
Sponsor:
Malcolm Grow Medical Clinics and Surgery Center
Organization:
Malcolm Grow Medical Clinics and Surgery Center
Study Overview
Official Title:
Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The summary of this research study is to test the effectiveness of a rapid rescue acupuncture technique as a non-pharmacologic alternative treatment for the reduction of post-traumatic stress disorder PTSD symptoms in affected individuals as a means to improve warfighter health and enable a more rapid return to duty especially in austere environments Patients will receive acupuncture as a research-related course of treatment for PTSD The PCL-5 questionnaire will be used to assess the presence and severity of PTSD symptoms A PCL-5 questionnaire will be administered at the beginning of the first treatment of rescue acupuncture and after the last treatment Following the acupuncture treatment a PCL-5 questionnaire will be initiated at the beginning of the first week of treatment and the end of the second week of treatment at the participating Mental Health Clinic pMHC
Detailed Description:
The objective is to treat three ARMS of PTSD patients ARM 1 Newly untreated diagnosed PTSD patients referred from a participating Mental Health Clinic pMHC who have not yet received any PTSD treatment for a 2-week therapy of rescue acupuncture six 30 minute sessions Monday Wednesday and Friday ARM 2 Newly diagnosed PTSD patients referred from the pMHC but already placed on pharmacological therapy ie Prazosin SSRI sedative etc prior to their enrollment in the pMHC and ARM 3 newly diagnosed PTSD patients with or without medications referred to pMHC but have a mild traumatic brain injury that does not impede their judgment ability ARMs 2 and 3 will follow the same rescue acupuncture program as ARM 1 A PCL-5 questionnaire will be administered prior to and after rescue acupuncture ARMs 1 2 and 3 patients will return to the pMHC after 2 weeks of rescue acupuncture to start or continue pharmacological andor non-pharmacological therapys and will also be evaluated by a PCL-5 questionnaire at the start and after 2 weeks Statistical analysis of the PCL-5 questionnaire will compare the three ARMS together as to whether acupuncture is a benefit or not to the patient following therapies received for 2 weeks in the pMHC The lowering of the PCL-5 symptomatic questionnaire score is a favorable indication of a benefit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None