Rapid Acupuncture Treatment for Post-Traumatic Stress Disorder

NCT05881174 | Completed

• 1 other identifier: 20190055H
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

PTSD

Keywords

Acupuncture; PTSD; PCL-5 Questionnaire

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Newly untreated diagnosed PTSD patients without medications

ACTIVE COMPARATOR

Newly untreated diagnosed PTSD patients who have not yet received any PTSD treatment for a 2-week therapy of acupuncture

Procedure: acupuncture

Newly diagnosed PTSD patients on pharmacological therapy

ACTIVE COMPARATOR

Newly diagnosed PTSD patients on pharmacological therapy for a 2-week therapy of acupuncture

Procedure: acupuncture

Newly diagnosed PTSD patients with or without medications with mild traumatic brain injury

ACTIVE COMPARATOR

Newly diagnosed PTSD patients with or without medications having mild traumatic brain injury for a 2-week therapy of acupuncture

Procedure: acupuncture

Interventions

acupuncture PROCEDURE

acupuncture

Newly diagnosed PTSD patients on pharmacological therapy; Newly diagnosed PTSD patients with or without medications with mild traumatic brain injury; Newly untreated diagnosed PTSD patients without medications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active duty and retired military referred from a participating Mental Health Clinic

You may not qualify if:

• Pregnancy Participated in a form of acupuncture in the last 3 months

Sponsors & Collaborators

• Malcolm Grow Medical Clinics and Surgery Center: lead
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Malcom Grow Medical Clinics and Surgery Center

Morningside, Maryland, 20762, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Richard C. Niemtzow, MD, PhD, MPH

  Malcolm Grow Medical Clinics and Surgery Center

  STUDY CHAIR

• Songxuan Zhou Niemtzow, MD, LAc

  Malcolm Grow Medical Clinics and Surgery Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Principal Investigator

Model Details: This is a 3 arm non-randomized, crossover-design clinical investigation using "rescue" acupuncture for the treatment of PTSD symptoms. Each patient receiving rescue acupuncture for PTSD will be their own "control."

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 31, 2023
• Study Start: November 24, 2020
• Primary Completion: October 18, 2023
• Study Completion: October 18, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)