Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 (i.e. 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 and/or non-pharmacological therapy(s) 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Newly untreated diagnosed PTSD patients without medications Newly untreated diagnosed PTSD patients who have not yet received any PTSD treatment for a 2-week therapy of acupuncture |
Procedure: acupuncture
acupuncture
|
| Active Comparator: Newly diagnosed PTSD patients on pharmacological therapy Newly diagnosed PTSD patients on pharmacological therapy for a 2-week therapy of acupuncture |
Procedure: acupuncture
acupuncture
|
| Active Comparator: Newly diagnosed PTSD patients with or without medications with mild traumatic brain injury Newly diagnosed PTSD patients with or without medications having mild traumatic brain injury for a 2-week therapy of acupuncture |
Procedure: acupuncture
acupuncture
|
Outcome Measures
Primary Outcome Measures
- The Post Traumatic Stress Disorder Checklist (PCL-5) for the Diagnosis and Statistical Manual of Mental Disorders (DMS-5) Analysis [6 Years]
Data will be analyzed using SAS v 9.4. The paired samples t-test will be used to assess the difference in PCL-5 score between pre and post acupuncture treatments. The paired samples t-test will be used to assess the difference in PCL-5 score between pre and post-pharmacological or non-pharmacological treatments. The ANOVA test will be used to assess differences in PCL-5 score between pharmacological, non-pharmacological or both pharmacological and non-pharmacological treatments. Mixed models will be used to assess differences in PCL-5 score between acupuncture treatments and pharmacological. The PCL-5 Analysis-pharmacological or both pharmacological and non-pharmacological treatment scale is a 20-item (0 = not at all, 4 = extremely) self-report measure that assesses the presence and severity of PTSD symptoms. The total severity score (min=0 and Max=80). A PCL-5 score of 31-33 or higher suggests the patient may benefit from PTSD treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
Active duty and retired military referred from a participating Mental Health Clinic
-
Exclusion Criteria:
Pregnancy Participated in a form of acupuncture in the last 3 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Malcom Grow Medical Clinics and Surgery Center | Morningside | Maryland | United States | 20762 |
Sponsors and Collaborators
- Malcolm Grow Medical Clinics and Surgery Center
- Uniformed Services University of the Health Sciences
Investigators
- Study Chair: Richard C. Niemtzow, MD, PhD, MPH, Malcolm Grow Medical Clinics and Surgery Center
- Study Director: Songxuan Zhou Niemtzow, MD, LAc, Malcolm Grow Medical Clinics and Surgery Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20190055H