Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder

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).

Study Overview

• Status: Completed
• Conditions: PTSD
• Intervention / Treatment: Procedure: acupuncture

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Morningside, Maryland, United States, 20762
      • Malcom Grow Medical Clinics and Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Post Traumatic Stress Disorder Checklist (PCL-5) for the Diagnosis and Statistical Manual of Mental Disorders (DMS-5) Analysis	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.	6 Years

Collaborators and Investigators

• Sponsor: Malcolm Grow Medical Clinics and Surgery Center
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Actual): October 18, 2023
• Study Completion (Actual): October 18, 2023

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: PTSD; Acupuncture; PCL-5 Questionnaire
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 20190055H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No